HEALTH TECHNOLOGY ASSESSMENT

VOLUME 18 ISSUE 49 AUGUST 2014

ISSN 1366-5278

Multicentre cluster randomised trial comparing

a community group exercise programme and
home-based exercise with usual care for people
aged 65 years and over in primary care

Steve Iliffe, Denise Kendrick, Richard Morris, Tahir Masud, Heather Gage,
Dawn Skelton, Susie Dinan, Ann Bowling, Mark Griffin, Deborah Haworth,
Glen Swanwick, Hannah Carpenter, Arun Kumar, Zoe Stevens,
Sheena Gawler, Cate Barlow, Juliette Cook and Carolyn Belcher

DOI 10.3310/hta18490
Multicentre cluster randomised trial
comparing a community group exercise
programme and home-based exercise with
usual care for people aged 65 years and
over in primary care

Steve Iliffe,1* Denise Kendrick,2 Richard Morris,1

Tahir Masud,3 Heather Gage,4 Dawn Skelton,5
Susie Dinan,1 Ann Bowling,6 Mark Griffin,1
Deborah Haworth,1 Glen Swanwick,2
Hannah Carpenter,2 Arun Kumar,2 Zoe Stevens,1
Sheena Gawler,1 Cate Barlow,1 Juliette Cook2
and Carolyn Belcher2
1Research Department of Primary Care and Population Health, University College
London, London, UK
2Division of Primary Care, University of Nottingham, Nottingham, UK
3Clinical Gerontology Research Unit, Nottingham University Hospitals NHS Trust,

Nottingham, UK
4Department of Economics, University of Surrey, Guildford, UK
5School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK
6Health Sciences, University of Southampton, Southampton, UK

*Corresponding author

Declared competing interests of authors: Dawn Skelton and Susie Dinan are directors for Later
Life Training, who deliver FaME and OEP training to health and leisure professionals across the UK.
The other authors declare that they have no competing interests.

Published August 2014

DOI: 10.3310/hta18490
This report should be referenced as follows:

Iliffe S, Kendrick D, Morris R, Masud T, Gage H, Skelton D, et al. Multicentre cluster randomised
trial comparing a community group exercise programme and home-based exercise with usual care
for people aged 65 years and over in primary care. Health Technol Assess 2014;18(49).

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Abstract

Multicentre cluster randomised trial comparing a community

group exercise programme and home-based exercise with
usual care for people aged 65 years and over in primary care

Steve Iliffe,1* Denise Kendrick,2 Richard Morris,1 Tahir Masud,3

Heather Gage,4 Dawn Skelton,5 Susie Dinan,1 Ann Bowling,6
Mark Griffin,1 Deborah Haworth,1 Glen Swanwick,2
Hannah Carpenter,2 Arun Kumar,2 Zoe Stevens,1 Sheena Gawler,1
Cate Barlow,1 Juliette Cook2 and Carolyn Belcher2
1Research Department of Primary Care and Population Health, University College London,
London, UK
2Division of Primary Care, University of Nottingham, Nottingham, UK
3Clinical Gerontology Research Unit, Nottingham University Hospitals NHS Trust, Nottingham, UK
4Department of Economics, University of Surrey, Guildford, UK
5School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK
6Health Sciences, University of Southampton, Southampton, UK

*Corresponding author s.iliffe@ucl.ac.uk

Background: Regular physical activity (PA) reduces the risk of falls and hip fractures, and mortality from
all causes. However, PA levels are low in the older population and previous intervention studies have
demonstrated only modest, short-term improvements.
Objective: To evaluate the impact of two exercise promotion programmes on PA in people aged
≥65 years.
Design: The ProAct65+ study was a pragmatic, three-arm parallel design, cluster randomised controlled
trial of class-based exercise [Falls Management Exercise (FaME) programme], home-based exercise
[Otago Exercise Programme (OEP)] and usual care among older people (aged ≥65 years) in primary care.
Setting: Forty-three UK-based general practices in London and Nottingham/Derby.
Participants: A total of 1256 people ≥65 years were recruited through their general practices to take part
in the trial.
Interventions: The FaME programme and OEP. FaME included weekly classes plus home exercises for
24 weeks and encouraged walking. OEP included home exercises supported by peer mentors (PMs)
for 24 weeks, and encouraged walking.
Main outcome measures: The primary outcome was the proportion that reported reaching the
recommended PA target of 150 minutes of moderate to vigorous physical activity (MVPA) per week,
12 months after cessation of the intervention. Secondary outcomes included functional assessments of
balance and falls risk, the incidence of falls, fear of falling, quality of life, social networks and self-efficacy.
An economic evaluation including participant and NHS costs was embedded in the clinical trial.

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 ABSTRACT

Results: In total, 20,507 patients from 43 general practices were invited to participate. Expressions of
interest were received from 2752 (13%) and 1256 (6%) consented to join the trial; 387 were allocated to
the FaME arm, 411 to the OEP arm and 458 to usual care. Primary outcome data were available at
12 months after the end of the intervention period for 830 (66%) of the study participants.The
proportions reporting at least 150 minutes of MVPA per week rose between baseline and 12 months
after the intervention from 40% to 49% in the FaME arm, from 41% to 43% in the OEP arm and from
37.5% to 38.0% in the usual-care arm. A significantly higher proportion in the FaME arm than in the
usual-care arm reported at least 150 minutes of MVPA per week at 12 months after the intervention
[adjusted odds ratio (AOR) 1.78, 95% confidence interval (CI) 1.11 to 2.87; p=0.02]. There was no
significant difference in MVPA between OEP and usual care (AOR 1.17, 95% CI 0.72 to 1.92; p=0.52).
Participants in the FaME arm added around 15 minutes of MVPA per day to their baseline physical activity
level. In the 12 months after the close of the intervention phase, there was a statistically significant
reduction in falls rate in the FaME arm compared with the usual-care arm (incidence rate ratio 0.74,
95% CI 0.55 to 0.99; p=0.042). Scores on the Physical Activity Scale for the Elderly showed a small but
statistically significant benefit for FaME compared with usual care, as did perceptions of benefits from
exercise. Balance confidence was significantly improved at 12 months post intervention in both arms
compared with the usual-care arm. There were no statistically significant differences between intervention
arms and the usual-care arm in other secondary outcomes, including quality-adjusted life-years. FaME is
more expensive than OEP delivered with PMs (£269 vs. £88 per participant in London; £218 vs. £117 in
Nottingham). The cost per extra person exercising at, or above, target was £1919.64 in London and
£1560.21 in Nottingham (mean £1739.93).
Conclusion: The FaME intervention increased self-reported PA levels among community-dwelling older
adults 12 months after the intervention, and significantly reduced falls. Both the FaME and OEP
interventions appeared to be safe, with no significant differences in adverse reactions between study arms.
Trial registration: This trial is registered as ISRCTN43453770.
Funding: This project was funded by the NIHR Health Technology Assessment programme and will be
published in full in Health Technology Assessment; Vol. 18, No. 49. See the NIHR Journals Library website
for further project information.

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Contents

List of tables xiii

List of figures xvii

List of abbreviations xix

Plain English summary xxi

Scientific summary xxiii

Chapter 1 Background: why this study was needed 1

Promoting physical activity 1

Chapter 2 Study design, including interventions 3

Objectives 3
Design 3
Participants and inclusion/exclusion criteria 3
Inclusion criteria for practices 3
Inclusion criteria for participants 3
Exclusion criteria for participants 4
Recruitment of practices 4
Recruitment of participants 4
Interventions 4
Home-based Otago Exercise Programme 4
Community-based Falls Management Exercise programme 5
Usual care 6
Cultural and ethnic sensitivity 6
Outcome measures 6
Ascertainment of outcomes 7
Baseline data collection 8
Follow-up data collection 8
Sample size 8
Randomisation 9
Concealment of allocation 9
Blinding 9
Withdrawals 9
Contamination 10
Statistical methods 10
Economic evaluation 10
Intervention costs 11
Service use 11
Economic analysis 13
Data sets 13
Risks 13
Adverse events 14

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 CONTENTS

Informed consent 14
Ethics committee approval 14
Management of the trial 15
Summary 15

Chapter 3 Modification of trial processes and procedures 17

Improving the recruitment of general practices and participants 17
Adding an eligibility screen 18
Peer mentor recruitment and training 19
Quality control of the Falls Management Exercise programme 20
Measuring falls, service use and physical activity 20
Capturing adverse events 23

Chapter 4 Recruitment of practices, postural stability instructors, peer mentors

and participants 25
Recruitment of general practices 25
Postural stability instructors 25
Peer mentors 25
Recruitment of participants 26
Baseline characteristics of the study population 26
Retention of participants 30

Chapter 5 The primary outcome and safety 35

Sensitivity analyses 40
Adherence analysis 40
Falls Management Exercise programme 40
Otago Exercise Programme 40
Safety: adverse events in the trial 41

Chapter 6 Secondary outcomes 45

Other physical activity measures 45
Falls and falls risk 45
Quality-of-life measures 45
Balance confidence and social networks 48
Other secondary outcomes (measures taken only at baseline and immediately
post intervention) 48

Chapter 7 Economic analysis 55

Intervention costs – NHS perspective 55
Otago Exercise Programme 55
Otago Exercise Programme resources 55
Otago Exercise Programme costs 55
Falls Management Exercise programme resources 55
Falls Management Exercise programme costs 55
Comparing OEP and FaME 57
Discussion 57
Intervention costs – private/participant perspective 58
Service use 60
Cost-effectiveness analysis 70
Discussion 70

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Chapter 8 Discussion 71
What this study shows 71
Comparison with other studies 72
Strengths and limitations of the study 72
Lessons learned 74
Conclusions 75

Acknowledgements 77

References 79

Appendix 1 ProAct65+ adverse event report form (from Chapter 2) 87

Appendix 2 Primary outcome – modelling physical activity (from Chapter 5) 89

Appendix 3 Adverse reactions (from Chapter 5) 91

Appendix 4 Secondary outcomes (from Chapter 6) 95

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

List of tables
TABLE 1 Time scale of PM recruitment 19

TABLE 2 Schedule of questionnaires used during the ProAct65+ trial 22

TABLE 3 Characteristics of practices in the ProAct65+ trial 26

TABLE 4 Planned and actual contacts between PMs and trial participants in the
OEP arm 26

TABLE 5 Baseline measures compared with normative data 28

TABLE 6 Univariate associations between attrition and sociodemographic data 32

TABLE 7 Univariate associations between attrition and risk factors for falling,
exercise, psychosocial and functional measures 33

TABLE 8 Proportion of participants achieving or exceeding MVPA target,

by arm and time 36

TABLE 9 Modelling of relative odds of reaching 150 minutes MVPA weekly,

after adjustment for baseline MVPA 37

TABLE 10 Results from multilevel modelling of 12-month post intervention

primary outcomes [loge(CHAMPS score+1)] 38

TABLE 11 Percentage reporting 0 minutes MVPA, by group at each follow-up 39

TABLE 12 Categories of harm experienced by participants in the trial 41

TABLE 13 Numbers of all AEs and ARs occurring during ProAct65+ trial, by arm 41

TABLE 14 Adverse events, reactions and incidents by arm, during the

intervention period and in the 12 months post intervention, per person-month 42

TABLE 15 Adverse events by type 43

TABLE 16 Analysis of total weekly caloric expenditure by intervention arm at

baseline and 12 months post intervention 46

TABLE 17 Comparisons of reported falls between intervention arms 46

TABLE 18 Distribution of FES-I scores by time and intervention arm 47

TABLE 19 Distribution of SF-12 physical and mental component scores by time

and intervention arm 47

TABLE 20 Distribution of OPQoL and EQ-5D scores by time and intervention arm 48

TABLE 21 Differences in balance confidence and social networks, by arm, over time 49

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 LIST OF TABLES

TABLE 22 FRAT scores and OEE scores by arm, over time 50

TABLE 23 Functional assessment scores, by arm, over time 51

TABLE 24 Outcomes for PASE, Phone-FITT and the mental and physical
components of the SF-12 scale 52

TABLE 25 Total OPQoL and FRAT scores, by arm 53

TABLE 26 Changes in dichotomised FRAT scores, by arm 53

TABLE 27 European Quality of Life-5 Dimensions: descriptive statistics by group

at baseline, post intervention and 6 and 12 months post intervention 54

TABLE 28 Otago Exercise Programme costs 56

TABLE 29 Falls Management Exercise programme costs 57

TABLE 30 Out-of-pocket expenditures 59

TABLE 31 Falls Management Exercise programme travel costs 60

TABLE 32 Falls Management Exercise programme opportunity costs 60

TABLE 33 Primary care service use per participant, during the 6-month
intervention and the 12-month follow-up: London and Nottingham combined 61

TABLE 34 Primary care service use per participant, during the 6-month
intervention and 12-month follow-up: London 63

TABLE 35 Primary care service use per participant, during the 6-month
intervention and 12-month follow-up: Nottingham 65

TABLE 36 Costs of primary care service use (£, 2011) per participant, during the
6-month intervention and 12-month follow-up 67

TABLE 37 Falls per participant, during the 6-month intervention and 12-month
follow-up, captured from GP records 69

TABLE 38 Means CHAMPS minutes moderate and Phone-FITT total score at

baseline for: those with a Phone-FITT and CHAMPS recorded at 12 months post
intervention; those with a Phone-FITT but no CHAMPS recorded at 12 months
post intervention; and, those with neither a Phone-FITT nor a CHAMPS recorded
at 12 months post intervention 89

TABLE 39 Means loge(CHAMPS minutes moderate+1) at baseline for: those with

a Phone-FITT and CHAMPS recorded at 12 months post intervention; those with
a Phone-FITT but no CHAMPS recorded at 12 months post intervention; and,
those with neither a Phone-FITT nor a CHAMPS recorded at 12 months
post intervention 89

TABLE 40 Comparison of CHAMPS score between adherers and non-adherers to

the FaME intervention 90

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

TABLE 41 Comparison of CHAMPS score between adherers and non-adherers to

the OEP intervention 90

TABLE 42 Distribution of secondary outcome measures of PA by time and

intervention arm 96

TABLE 43 Distribution of secondary outcome measures of fear of falling (FES-I)

by time and intervention arm 98

TABLE 44 Distribution of measures of quality of life by time and intervention arm 100

TABLE 45 Other self-efficacy outcome measures 103

TABLE 46 Distribution of measures taken only at baseline and post intervention

by time and intervention arm 105

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

List of figures
FIGURE 1 Flow chart of the recruitment and assessment process in the
ProAct65+ trial 18

FIGURE 2 Number of PMs trained 19

FIGURE 3 Postural stability instructors quality assurance checklist 21

FIGURE 4 The ProAct65+ risk management pathway 24

FIGURE 5 Recruitment of participants to the trial 27

FIGURE 6 Educational attainment among trial participants 28

FIGURE 7 The CONSORT diagram 31

FIGURE 8 Proportion achieving or exceeding MVPA target, by arm over time 36

FIGURE 9 Box and whisker plot of minutes of MVPA 12 months post intervention
by group, according to CHAMPS questionnaire 37

FIGURE 10 Geometric means of number of minutes of MVPA by group and time,

according to CHAMPS questionnaire 37

FIGURE 11 Proportion of participants recording 0 minutes of MVPA per week,

by arm over time 39

FIGURE 12 Line graph to show means of total calorie expenditure by time and
intervention arm 97

FIGURE 13 Line graph to show means of PASE score by time and intervention arm 97

FIGURE 14 Line graph to show means of Phone-FITT score by time and

intervention arm 97

FIGURE 15 Line graph to show means of FES-I score by time and intervention arm 99

FIGURE 16 Line graph to show means of quality-of-life measures by time and

intervention arm 101

FIGURE 17 Line graphs of other measures 104

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

List of abbreviations

A&E accident and emergency LSNS Lubben Social Network Scale

AE adverse event MSPSS Multidimensional Scale of Perceived
Social Support
AI adverse incident
MVPA moderate to vigorous physical
AFRIS Attitudes to Falls-Related
activity
Interventions Scale
OEE Outcome Expectation for Exercise
AOR adjusted odds ratio
OEP Otago Exercise Programme
AR adverse reaction
OPQoL Older People’s Quality of
BP blood pressure
Life Questionnaire
CHAMPS Community Healthy Activities
OR odds ratio
Model Program for Seniors
PA physical activity
CI confidence interval
PASE Physical Activity Scale for
ConfBal Confidence in Balance scale
the Elderly
CONSORT Consolidated Standards of
PCRN Primary Care Research Network
Reporting Trials
PCT primary care trust
EQ-5D European Quality of Life-5
Dimensions PM peer mentor
FaME Falls Management Exercise PPI patient and public involvement
programme
PSI postural stability instructor
FES-I Falls Efficacy Scale-International
QALY quality-adjusted life-year
FRAT Falls Risk Assessment Tool
RCT randomised controlled trial
GP general practitioner
SAE serious adverse event
ICC intrapractice correlation coefficient
SD standard deviation
ICER incremental cost-effectiveness ratio
SF-12 Short Form questionnaire-12 items
IMD Index of Multiple Deprivation
TSC Trial Steering Committee
IMD2007 Index of Multiple Deprivation 2007
TUG timed get-up and go test
IRR incidence rate ratio

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Plain English summary

P hysical activity (PA) in later life can improve physical and mental health and quality of life, yet many
older adults are inactive.

The ProAct65+ trial tested two methods of promoting PA with older people, one with weekly classes
and the other with home exercises, both for 24 weeks. The aim of the study was to examine if the two
exercise programmes were effective in increasing levels of PA 12 months after each programme ended.

We invited people aged ≥65 years from 43 general practices to take part in the study, and 1256 did so.
Practices were randomly allocated to have class exercises, home exercise or usual care (with no special
exercise plan). We measured different aspects of health and well-being. The aim was to increase the
proportion of participants who reached or exceeded 150 minutes per week of moderate to vigorous PA.

Participants were followed up for 12 months after the exercise intervention ended. Significantly more of
those participants in the exercise classes than in the usual-care group reached the target for PA at the
12-month follow-up. Those who had home exercise alone were no more likely to reach the PA target
compared with the usual-care group. At follow-up the exercise class group had significantly fewer falls
than the usual-care group, but there was no significant difference for the exercise at home group.
Participants in the exercise class arm were more likely to be positive about exercise at follow-up.
There were no other changes in health and well-being.

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Scientific summary

Objective

The primary objective of the ProAct65+ trial was to determine the effect of two evidence-based exercise
programmes designed for older people, compared with usual care, on the achievement of recommended
physical activity (PA) targets 12 months after cessation of the intervention. A pragmatic, three-arm parallel
design, cluster-controlled trial was employed, with allocation at the level of general practice. Participants
were from UK-based general practices in London, Nottingham and Derby which agreed to participate in
the trial and their patients aged ≥65 years, who gave informed consent to participate.

Eligibility

Practices were eligible to participate if they committed themselves for the duration of the trial and if
community venues suitable for exercise classes were available in their catchment area. General practices
were recruited with assistance from the Primary Care Research Networks (PCRNs) in London (Greater
London PCRN) and Nottingham/Derby (East Midlands and South Yorkshire PCRN). Practices produced lists
of patients aged ≥65 years, and screened patients using the exclusion criteria. Sampling varied by practice
size, with all patients aged ≥65 years being invited where there were fewer than 600 patients in this age
group. Larger practices were provided with a random number list to identify up to 600 patients to invite.
Patients were sent trial invitation letters from their usual general practitioner (GP).

Patients aged ≥65 years who were independently mobile (with or without a walking aid) and physically
able to take part in a group exercise class were eligible to join the study. Patients were excluded if they
had experienced three or more falls in the previous year, had unstable clinical conditions, would be unable
to follow instructions about exercise safely or were receiving palliative care. In addition, those who were
already exercising at, or above, the target level were identified during the telephone call to arrange an
assessment visit, and excluded. Exclusion criteria were further reviewed by the research team at the
participant’s recruitment visit and GPs confirmed eligibility for all participants.

Design

The trial had three arms:

1. the home-based Otago Exercise Programme (OEP)

2. a community-based group exercise programme [Falls Management Exercise (FaME)]
3. usual care.

Home-based exercise programme (Otago Exercise Programme)

This comprised 30 minutes of leg muscle strengthening and balance retraining exercises, progressing in
difficulty, to be performed at home at least three times per week, and a walking plan for up to 30 minutes
at a moderate pace to be undertaken at least two times per week for 24 weeks. Participants received an
instruction booklet and ankle cuff weights (starting at 1kg) to provide resistance for strengthening
exercises. The programme was tailored for, and introduced to, participants by trained research staff in a
group session or at participants’ homes if they could not attend the session. Where available, trained peer
mentors (PMs) visited participants at home to start the exercise programme and carried out a further four
home visits (as the participants required) and up to 12 telephone contacts.

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 SCIENTIFIC SUMMARY

Community-based group exercise programme (Falls Management Exercise)

The FaME programme comprised a 1-hour-long postural stability instructor (PSI)-delivered group exercise
class in a local community centre for a maximum of 15 participants, and two 30-minute home exercise
sessions per week (based on the OEP, with an instruction booklet) for 24 weeks. Participants were advised
to walk at least twice per week for up to 30 minutes at a moderate pace. The programme included leg
muscle strengthening and balance retraining exercises that progressed in difficulty, progressive trunk and
arm muscle strengthening, bone loading, endurance (including walking) and flexibility training, functional
floor skills and adapted tai chi. Resistance bands and mats were used throughout the programme. Group
exercises included retraining of the ability to get up from, and down to, the floor (using a backward
chaining approach), floor exercises to improve balance, trunk and lower body strength and flexibility, and
coping strategies to reduce the risk of complications resulting from a long lie and its complications.

Usual care
Participants in the usual-care arm were not offered either the OEP or FaME programmes, but were free to
participate in any other non-trial-related exercise.

Outcomes

The primary outcome was the proportion of participants reaching or exceeding the national recommended
target of ≥150 minutes of moderate to vigorous physical activity (MVPA) per week at 12 months after the
cessation of the intervention. This was measured using the Community Healthy Activities Model Program
For Seniors (CHAMPS) scale. This was supplemented by two other PA measures, the Physical Activity Scale
for the Elderly (PASE) and a telephone questionnaire, Phone-FITT.

Secondary outcomes included:

1. direct health benefits (i.e. functional and psychological status, the rate of falls, the number and nature
of falls, and fear of falling)
2. self-efficacy for exercise and participants’ judgement of the value or importance of PA
3. health-related quality of life and quality-adjusted life-years (QALYs)
4. the NHS and private (participant) costs of each exercise programme, and possible cost offsets, identified
from a comparison of health and social service utilisation of participants in all groups during the
study period.

Allocation, blinding and withdrawal

Each practice was allocated to a treatment arm once all participants within that practice were recruited.
General practices, their participants, and researchers having contact with practices and participants were
blind to treatment arm until all participants within a practice were recruited. It was not possible to blind
participants to treatment arm because of the nature of the interventions. Participants could withdraw from
the trial at their own request. Data collected to the date of withdrawal were used in the analysis unless the
withdrawing participant requested otherwise.

Analysis

Comparisons between treatment arms were made using random-effects models to allow for clustering
between practices. Linear regression models were used for continuous outcome variables, logistic models
for binary outcome variables and negative binomial models for data on rate of falls. The primary outcome
was the proportions reaching the recommended PA target of at least 150 minutes of activity of moderate
to vigorous intensity each week. The CHAMPS score measuring minutes of PA followed a log-normal
distribution and contained many zeros, and was therefore transformed to loge (CHAMPS score+1).
The proportions whose weekly MVPA exceeded 150 minutes, and those who reported zero MVPA,

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were tabulated for all time points. All analyses were adjusted for variables used in minimisation (study site,
deprivation and practice list size), and for baseline values of the outcome measures. Differential effects of
the intervention by age (> or <75 years) and sex were assessed for the primary outcome measures by
adding terms for the interaction.

Analysis of each outcome measure was primarily conducted on complete cases. For the primary outcome,
analysis was repeated with multiple imputation of missing data firstly for those who had 12 months’
post-intervention data from the telephone-administered Phone-FITT PA questionnaire, using the Phone-FITT
score, and then for all participants, using all variables in the substantive model and Phone-FITT (at baseline
and 12 months). This was done with, and without, stratification by practice.

The full analysis set comprised all randomised participants for whom one post-baseline assessment
of the primary outcome measure was available. People who did not attend classes were included in an
intention-to-treat analysis.

Economic analysis
The costs of the exercise interventions were calculated from NHS and participant perspectives using study
protocols and records, and participant diaries, respectively. The extent to which costs of the interventions
were offset by savings elsewhere in the health-care system was explored through analysis of primary care
service utilisation, and hospital treatment for injurious falls during the 6-month intervention period and for
the 12 months post intervention. QALY gains from exercise were investigated using European Quality of
Life-5 Dimensions utility indices obtained by transforming Short Form questionnaire-12 items scores.
Cost-effectiveness was calculated using the primary PA outcome (proportion achieving at least
150 minutes of moderate or vigorous intensity PA per week) at 12 months post intervention.

Safety
The medical records were checked by GPs for all recruited participants for suitability prior to
commencement of the interventions. Safe exercise guidelines were followed, pre-exercise assessments
were conducted, and exercise intensity and difficulty were increased with caution to minimise injury risk.
Adverse events (AEs) and serious AEs were assessed for seriousness, expectedness and causality, and
recorded and monitored until resolution, stabilisation, or until shown that the study intervention was not
the cause.

Ethics and consent

Written informed consent was obtained from all participants to participate in the trial, and to allow
researchers to review medical records for the purposes of measuring service use and AEs. Ethical approval
was granted to the trial from Nottingham Research Ethics Committee 2 (application number 08/H0408/72).
National Health Service Research & Development approval was granted by NHS Nottingham City,
Nottinghamshire County, Derby City, Derbyshire County and Westminster, Brent, Harrow, Hounslow and
Barnet & Enfield Primary Care Trusts.

Results

Forty-three practices were recruited to the trial. The target of recruiting 12 PSIs per site was achieved and
FaME arm classes were fully staffed. Thirty-eight PMs were recruited, trained and deployed in the trial:
31 in London and seven in the Nottingham/Derby practices. In total, 20,507 patients were invited to
participate. Expressions of interest were received from 2752 (13%) patients and 1256 (6% of those
approached) consented. Three hundred and eighty-seven participants were allocated to the FaME arm,
411 to the OEP arm and 458 to the usual-care arm. One participant withdrew after consenting but before
baseline assessment could be completed, and one withdrew during the intervention period, requesting
deletion of all data. Trial participants performed below normative levels on most scales, suggesting that
they were a population which would benefit from increased PA.

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 SCIENTIFIC SUMMARY

Recruitment and retention

Of the 1256 randomised study participants, 830 (66.1%) remained in the trial at the primary end point,
12 months after the end of the intervention period. The recruitment of older people who would benefit from
increasing their PA (as shown by their performance on a range of functional and psychological measures)
to trials is possible in general practice. Retention of trial participants in the study remained problematic,
despite the efforts made to increase it.

Primary outcome
The proportions reporting at least 150 minutes of MVPA per week rose from 40% to 49% in the FaME
arm, from 41% to 43% in the OEP arm, and from 37.5% to 38.0% in the usual-care arm. Participants
in the FaME arm, compared with the usual-care arm, reported more MVPA at 12 months after the
intervention, adding around 15 minutes of MVPA per day. There was no statistically significant increase in
MVPA in the OEP arm compared with the usual-care arm. The interventions were safe. There were no
statistically significant differences in possible or probable adverse reactions between arms, during or after
the intervention period.

Secondary outcomes
In the 12 months after the close of the intervention phase there was a statistically significant reduction in
falls in the FaME arm compared with the usual-care arm [incidence rate ratio 0.74, 95% confidence
interval (CI) 0.55 to 0.99; p=0.042]. Although there were fewer falls in the OEP arm, there was no
statistically significant difference between the OEP and usual-care arms.

Scores on the PASE showed a small, but statistically significant, benefit for FaME compared with usual care
(difference in means 11.2, 95% CI 0.2 to 20.2; p=0.046), but no statistically significant benefit for OEP
(difference in means 7.5, 95% CI –3.8 to 18.8; p=0.20). Significant improvements were seen in balance
confidence for both intervention arms at 12 months post intervention. The mean difference for FaME
compared with usual care was –0.529 (95% CI –0.998 to –0.061; p=0.027), while the mean difference
for OEP compared with usual care was –0.545 (95% CI –1.033 to –0.057; p=0.029). Participants in the
FaME and OEP arms were significantly less likely to dismiss exercise as not beneficial and, in the FaME arm,
were more likely to be positive about exercise, 12 months after the end of the interventions. There were
no other statistically significant differences between intervention arms and the usual-care arm in self-
efficacy, mental and physical well-being, quality of life, balance confidence, social networks, falls risk or
functional abilities.

Economic analysis
The FaME programme is more expensive than OEP delivered with PMs (£269 vs. £88 per participant in
London; £218 vs. £117 in Nottingham). There were no differences in primary care service use between
groups, or in costs of hospital treatment for injurious falls over the 6-month intervention period or the
subsequent 12 months. The study failed to find a significant difference between the groups in terms of
QALYs. As the FaME programme, when compared with usual-care, results in 14% more participants
achieving the target of 150 minutes of MVPA at 12 months post intervention, the cost per extra person
exercising was £1920 in London and £1560 in Nottingham (mean £1740).

Conclusions

The FaME programme significantly increased MVPA and a significantly higher proportion of
community-dwelling older adults reached the recommended target for 150 minutes of MVPA per week
compared with usual care up to 12 months after the end of the intervention. No significant effect was
found for the OEP on MVPA compared with usual care. The FaME programme significantly reduced the
number of falls in the 12 months following the end of the intervention compared with usual care,
but no significant effect was found for the OEP on the number of falls.

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The FaME intervention increased PA levels, and reduced falls, but further studies are needed to measure
attenuation of these effects over time and to test the impact of reinforcement of the intervention. Ways of
recruiting the less-active population need further exploration. Community-based exercise programmes
proposing to use PMs should explore the feasibility of this prior to embarking on the programme, and
strategies to optimise PM motivation and involvement need further investigation.

Trial registration

This trial is registered as ISRCTN43453770.

Funding

Funding for this study was provided by the Health Technology Assessment programme of the National
Institute for Health Research.

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This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Chapter 1 Background: why this study

was needed
T he health benefits of physical activity (PA) include reductions in the risk of cardiovascular disease,
type 2 diabetes, osteoporosis and certain cancers.1 There is growing evidence of an association
between regular PA and a reduced risk of all-cause mortality,2 and of the potential savings for NHS
budgets from exercise promotion for older adults.3 Sedentary behaviour increases the risk of dependence,
falls and fractures. Sustained levels of PA in adulthood maintain bone strength and can prevent fragility
fractures in later life. Research has shown that a lifetime’s history of regular PA can reduce the risk of hip
fracture by up to 50% and much of this benefit is thought to result from a reduction in falls.4 It is now
clear that habitual PA and improved access to exercise opportunities is an important public health
approach to the prevention of functional decline that can lead to frailty, falls and fractures.5

Falls are common in people aged ≥65 years and can have serious consequences, including injury, pain,
impaired function, loss of confidence in carrying out everyday activities, loss of independence and
autonomy, and even death.6,7 There is evidence that interventions providing some form of exercise may be
effective in preventing falls among older people8 and that health-care costs9,10 could be reduced if the
number of falls was reduced.7,11–14

Current PA recommendations propose a target of 150 minutes of moderate to vigorous physical activity
(MVPA) per week.15 However, surveys have consistently shown a high prevalence of physical inactivity in
the UK population.16 A systematic review comparing 17 randomised controlled trials (RCTs) with different
interventions designed to encourage sedentary, community-dwelling adults to do more PA17 concluded
that interventions were effective in the short- and mid-term, at least in middle age, and that there were no
significant increases in adverse events (AEs) in the four studies that reported them. However, it is unclear
which individual interventions (e.g. home- or facility-based) are the most effective in increasing PA in the
long term or in specific groups (e.g. older people).

Promoting physical activity

The NHS has attempted to address the problem of inactivity in a variety of ways, including exercise referral
schemes in primary care (‘exercise on prescription’), which were provided by approximately 90% of primary
care trusts (PCTs) in the 2000s and usually involved referring patients to local leisure centres.18 Although
exercise on prescription has been shown to be feasible and effective in vulnerable older people,19 there
appear to be significant barriers to the uptake of exercise classes in leisure centres. For many older people,
home exercise or group exercise in non-intimidating environments (e.g. community halls) may be more
appealing, and result in higher uptake of exercise programmes and longer continuation of exercise. Peer
activity mentors have also been shown to be effective in increasing uptake and adherence to exercise.20-23

There are currently two existing exercise programmes designed for use in community settings with people
aged ≥65 years. The first is a home-based programme, the Otago Exercise Programme (OEP), and the second
is a community-based group exercise programme, the Falls Management Exercise (FaME) programme.

The OEP24–30 and FaME programme31,32 are both designed for use in community settings, specifically for
people aged ≥65 years, to reduce falls. FaME is based on the components of fitness and principles of
programming for all older adults (i.e. warm-up, mobility, stretches, strength and balance, endurance and a
cool down), while OEP includes brief warm-up and strength and balance exercises appropriate for the age
group. Both programmes involve strength and balance training which is tailored to the individual’s ability
and health status.

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 BACKGROUND: WHY THIS STUDY WAS NEEDED

The OEP is a home-based exercise programme for older people which is effective in reducing falls and
fall-related injuries, improving balance, strength and confidence in performing everyday activities without
falling, and has been shown to be cost-effective for people aged ≥80 years.24–30 It was designed to be
delivered by physiotherapists, and nurses trained and supervised by physiotherapists. A 1-year evaluation of
the OEP showed considerable improvements in outdoor activities (walking, shopping, gardening and other
outside leisure activities) after 6 months (Professor A J Campbell, University of Otago, 2007, personal
communication) with participants continuing to exercise after completing the programme. It also showed
significant improvements in executive function after 6 months.30 While the OEP has been evaluated in four
controlled trials of older primary care patients in New Zealand and one RCT in Canada, it has not been
tested in a primary care setting in the UK for its feasibility, impact, acceptability and cost-effectiveness.

The FaME programme is a group exercise programme which was developed and tested in a controlled trial
in the UK,31 but not in a primary care population. It aims to improve balance33 and was designed to be
delivered by qualified postural stability instructors (PSIs).32 It has been shown to be effective in reducing
falls, and injuries resulting from falls.16,31 Good adherence was demonstrated with the FaME programme
and nearly two-thirds of people participating in FaME continued in group exercise programmes for over
1 year after trial completion (Professor D A Skelton, Glasgow Caledonian University, 2007, personal
communication). The FaME programme remains to be evaluated for its impact, acceptability and
cost-effectiveness within primary care.

This trial aimed to fill the gaps in the current evidence base by evaluating the delivery, impact, acceptability
and cost-effectiveness of a community-based exercise programme (FaME) and a home-based exercise
programme (OEP) supported by similarly aged (peer) mentors (PMs), compared with usual care for primary
care patients. The underlying assumption was that the exercises would produce sufficient subjective
well-being and improved mobility to encourage continuation of higher levels of PA after the cessation of
the intervention. Each exercise programme was compared with usual care for effectiveness in producing
sustained change in PA. The two programmes would be compared for cost-effectiveness if both were
effective in promoting sustained change in PA. Our primary hypotheses at the start of the study were
(1) both exercise programmes would produce sustained changes in PA compared with usual care and
(2) OEP would be more cost-effective than FaME.

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Chapter 2 Study design, including interventions

T his chapter describes the trial as originally designed and is a summary of the full protocol.34

Objectives

The primary objective of the ProAct65+ study was to determine the effect of two evidence-based exercise
programmes designed for older people compared with usual care (i.e. with no special interventions to
promote PA), on the achievement of recommended PA targets 12 months after cessation of intervention.

The secondary objectives were to:

1. determine the health benefits of the two programmes to participants starting at various levels of
PA – particularly the effects on physical and psychological status, health status, health-related quality of
life and quality-adjusted life-years (QALYs)
2. estimate the costs of the exercise interventions, and possible cost offsets, and to assess the
cost-effectiveness of community group exercise, and home-supported exercise compared with usual care
3. determine the acceptability of the programmes, adherence rates, enabling factors and barriers to
future implementation
4. compare the time course of responses by participants, in terms of exercising at the recommended
levels, at 0, 6, 12, 18 and 24 months after cessation of the intervention, between those undergoing the
exercise programmes and those receiving usual care
5. determine participants’ perceptions of the value of exercise and the predictors of continued exercise.

Design

The ProAct65+ study was based on a three-arm, parallel design, cluster-controlled trial comparing a
community centre-based group exercise programme (FaME), with a home-based exercise programme and
walking plan (OEP) and with usual care, and using minimisation for allocation at the level of general practice
in two UK centres (London and Nottingham/Derby). We initially planned 2 years’ follow-up post intervention
to determine the impact, acceptability and adherence to the programme, longer-term continuation of
exercise and cost-effectiveness. The Consolidated Standards of Reporting Trials (CONSORT) diagram35
summarises the design (see Figure 7).

Participants and inclusion/exclusion criteria

Participants were patients aged ≥65 years registered with participating general practices who gave
informed consent to participate.

Inclusion criteria for practices

Inclusion criteria for practices were (1) a commitment to participate over the duration of the study and
(2) the availability of a suitable community venue in the practice catchment area.

Inclusion criteria for participants

Those aged ≥65 years who could walk independently both indoors and outdoors (with or without a
walking aid and without help from another person), and who would be physically able to take part in a
group exercise class, were eligible to participate in the trial.

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 STUDY DESIGN, INCLUDING INTERVENTIONS

Exclusion criteria for participants

Those with any of the following criteria were excluded:

l three or more self-reported falls in the previous year

l resting blood pressure (BP) >180/100mmHg; tachycardia >100 beats per minute; those considered by
their general practitioner (GP) to have uncontrolled hypertension; significant drop in BP during exercise
previously recorded in the participant’s medical records, or found at initial assessment
l psychiatric conditions which would prevent participation in an exercise class (e.g. psychotic illness)
l uncontrolled medical problems, which the GP considered would exclude patients from undertaking the
exercise programme (e.g. acute systemic illness such as pneumonia, poorly controlled angina, acute
rheumatoid arthritis, unstable or acute heart failure)
l conditions requiring a specialist exercise programme (e.g. uncontrolled epilepsy, significant neurological
disease or impairment; unable to maintain seated upright position or unable to move about
independently indoors)
l not living independently (e.g. living in residential or nursing homes)
l significant cognitive impairment (resulting in the individual being unable to follow simple instructions)
l already receiving long-term physiotherapy or already in an exercise programme.

Exclusion criteria were checked at the recruitment appointment by the researcher. This assessment
included measurement of resting BP and pulse, functional assessments and completion of a health
questionnaire. GPs were asked to confirm eligibility for each potentially eligible participant. A further
exclusion criterion of those already exercising at, or above, the target level was introduced early in the trial
(see Chapter 3 for details).

Recruitment of practices
General practices were recruited through the Primary Care Research Networks (PCRNs) in London and
Nottingham/Derby. The PCRNs were asked to identify potential participant practices. Mailed invitations,
telephone contact with practice managers and personal contact with local GP opinion leaders were used
as necessary.36–38

Recruitment of participants
Practices produced a single numbered list of patients aged ≥65 years. Practice clinical staff were allowed
to make and justify their own exclusions in liaison with the research team. The research team provided the
practices with a random number list to select the sample of patients to be approached after exclusions had
been made. Our intention was that the sampling would vary depending on practice size. In practices with
fewer than 450 patients aged ≥65 years, all patients aged ≥65 years would be invited to participate. In
larger practices random sampling would be used to identify 450 patients aged ≥65 years who would be
invited to participate. Patients were then sent invitation letters about the trial by their usual GP.

Interventions

There were three arms to the trial:

1. home-based exercise programme and walking plan (OEP)

2. community centre-based group exercise programme (FaME)
3. usual care.

Home-based Otago Exercise Programme

This consisted of a 30-minute programme of leg muscle strengthening and balance retraining exercises,
progressing in difficulty, to be performed at home at least three times per week, and a walking plan
to be undertaken at least two times per week for 24 weeks. Each participant received an instruction
booklet and ankle cuff weights (starting at 1kg) to provide resistance for the strengthening exercises.

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

The OEP intervention is described as ‘moderate’ intensity by the original authors,24 and is designed to be
performed unsupervised in the patient’s home and is less intense than the FaME programme.

The programme was introduced to participants by trained research staff, at an appropriate starting level
determined at an initial assessment, in either a group setting or at home, depending on circumstances.
Mentor support has been shown to be effective in increasing adherence,20–22 so in the initial plan of this
intervention trained PMs then contacted and visited the participants at home to start the exercise
programme, and followed them up at home with up to three more visits (as the participants required).
Participants were asked to record the days they carried out the programme and mentors telephoned them
fortnightly to encourage activity and prompt progression of exercises. Mentors recorded and reported any
problems encountered with the exercise programme to the research team using an AE form developed for
the study (see Appendix 1). The delivery of the OEP was standardised through training of PMs before the
trial started, and there was regular contact with the participants and PMs to check that exercise protocols
were being followed.

Community-based Falls Management Exercise programme

The FaME programme comprises 1-hour-long group exercise class in a local community centre for a
maximum of 15 participants and two 30-minute home exercise sessions (based on the OEP) per week for
24 weeks. These classes were run by PSIs, trained to promote exercise with older people. Participants were
advised to walk at least twice per week for up to 30 minutes at a moderate pace. The FaME intervention is
a more comprehensive intervention, containing both floor exercises and cardiovascular exercises that the
OEP does not contain, and is more intense. The balance section is challenging. The programme included
leg muscle strengthening and balance retraining that progressed in difficulty. Progressive trunk and arm
muscle strengthening, bone loading, endurance (including walking) and flexibility training, functional floor
skills (see below) and adapted tai chi completed this evidence-based programme. Ankle cuff weights,
TheraBands™ (elastic resistance training bands) and mats are also used throughout the programme. The
group exercises include retraining of the ability to get up from the floor and floor exercises to improve
strength, balance and coping strategies to reduce the risk of complications resulting from a long lie.32 The
delivery of the FaME programme was standardised through training of PSIs before the trial started and
there were regular quality assurance visits to the FaME classes to check that intervention delivery protocols
were being followed.

The PSIs kept a register of attendance and recorded tailoring of the programme and any feedback from
participants. They followed up non-attenders by telephone as necessary, recording any positive or negative
feedback and notified the research team about reasons for non-attendance or drop out. Participants were
given a personalised booklet containing their home exercise instructions.

Initially we planned that FaME groups would have 9 or 10 participants, so there would be four or five
classes per week for each of the practices allocated to this arm. The number of PSIs running these classes
was determined by their availability, but the aim was to maximise continuity and standardisation of PA
training, so the ideal arrangement was to have one PSI leading all groups in one practice. We expected to
follow a similar approach to continuity of PMs for participants in the OEP arm.

A starting level for both interventions was determined from baseline assessments and instructor
observation in week 1 in FaME, and at the technique instruction class at the beginning of the OEP.
Experienced exercise instructors carried out standardised quality assurance visits to FaME classes and
reviewed PM paperwork for evidence of tailoring of exercises and of progression in exercise intensity.

General practitioners in participating practices allocated to either the FaME programme or OEP were
discouraged from referring participants involved in the trial to other exercise therapy programmes outside
of the study.

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR
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 STUDY DESIGN, INCLUDING INTERVENTIONS

Usual care
Participants in the usual-care arm were not offered either the OEP or FaME programme, but were free to
participate in any other exercise just as they would if they were not participating in the trial.

Cultural and ethnic sensitivity

Cultural and religious requirements were accommodated within the exercise programmes. The
recommendations from the Help the Aged Minority Ethnic Elders Falls Prevention Programme
(www.helptheaged.org.uk/meefp) were followed. In addition, the research team were advised by the
English Disability Sports Federation and the Integrated Fitness Initiative’s ‘Physical Activity Provision for
Ethnic Minority Groups’ Project Development Team. In particular, the FaME group class leaders ensured
that recommendations for attire respected cultural customs and religious beliefs for a range of
ethnic groups.

We made provision for single-sex exercise groups to be scheduled as required, and separate changing
facilities and same gender instructors were available wherever possible. Windows in the exercise
classrooms were screened as appropriate. Family support was encouraged and classes were provided at
different times of the day. The OEP also respected participants’ preferences regarding family support and
participation in the home exercise programme.

All research material and exercise manuals had a maximum reading age of 9 years. Inability to read the
material was not a formal exclusion criterion as the individual may be able to follow movement and
correction accurately in classes and family members were allowed to act as interpreters. Where possible,
invitation letters and information sheets were translated into local languages.

Outcome measures

The primary and secondary outcome measures were chosen to reflect the needs of participants
(e.g. functional outcomes, falls, confidence, quality of life, participant costs), and of commissioners of
exercise services in primary care and policy makers (e.g. PA, falls, NHS costs).

The primary outcome was the proportion of participants reaching the recommended PA target of at least
30 minutes of activity of moderate intensity on at least 5 days each week, measured using the Community
Healthy Activities Model Program For Seniors scale (CHAMPS) questionnaires. Although measures were
taken at 0, 6, 12, 18 and 24 months after the intervention, our primary analysis was of data collected at
12 months post intervention, as a previous study in New Zealand had suggested that this was the time
when the effect of the intervention was maximal.39

The secondary outcomes included:

1. the direct health benefits, i.e. functional and psychological status, the rate of falls (the major safety
outcome measure), the number and nature of falls, and fear of falling
2. self-efficacy for exercise and physical self-perception (self-esteem relative to the physical domain), which
includes measurement of perceived importance (the degree to which participants value their physical
condition, body image and physical strength) to inform predictors of exercise adherence and
continuation, and participants’ judgement of the value or importance of PA
3. health-related quality of life and QALYs40
4. the NHS and private (participant) costs of each exercise programme, and possible cost offsets, identified
from a comparison of health and social service utilisation of participants in all groups during the
study period.

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Ascertainment of outcomes
The following functional assessments were used by researchers at baseline and at the end of the
interventions (and at 6 months after allocation in the usual-care arm):

1. Modified Clinical Romberg Static Balance test, eyes open and closed41
2. timed get-up and go (TUG) as a measure of balance and falls risk42
3. functional reach as a measure of balance and falls risk43
4. 30-second chair rise as a measure of lower limb strength and power.44

The following validated tools were used at baseline and as self-completion questionnaires at follow-up:

1. Confidence in balance as measured by the Confidence in Balance (ConfBal) scale.45 A total score is
provided as a measure of confidence.
2. Confidence in carrying out a range of basic activities of daily living without falling as measured by the
Falls Efficacy Scale-International (FES-I).46
3. Readiness to change as measured by the transtheoretical model,47 applying it to exercise behaviour to
determine perceived barriers48 and self-efficacy for exercise.49 Expectations of exercise were measured
with the Outcome Expectation for Exercise (OEE) scale-2, a 13-item measure with two subscales:
positive and negative OEE.50
4. Quality of life was measured using the Older People’s Quality of Life Questionnaire (OPQoL).51–53
5. Social network size and density was measured using the brief Lubben Social Network scale (LSNS)54 and
perceived social support was measured by the Multidimensional Scale of Perceived Social
Support (MSPSS).55
6. Subjective habitual PA was assessed using a number of validated questionnaires to ensure all domains
of activity and sport are considered, including the Phone-FITT, Physical Activity Scale for the Elderly
(PASE) and CHAMPS22,56,57 and the current level of activity questions used in the Household Survey.58
7. Attitudes and beliefs about falls prevention interventions were measured using the Attitudes to
Falls-Related Interventions Scale (AFRIS) questionnaire.59
8. Falls risk was measured by the Falls Risk Assessment Tool (FRAT).60
9. Health-related quality of life was measured by the Short Form questionnaire-12 items (SF-12).61
Quality-adjusted Life-years, which are the main outcome for the economic analysis, were based on
European Quality of Life-5 Dimensions (EQ-5D) utility weights obtained by transforming SF-12 scores.40

In addition, demographic information, co-morbidity, medication, use of general practice and hospital and
community social services were recorded at baseline and updated at subsequent assessments. Falls were
ascertained by self-completed fall diaries (completed 4-weekly during the intervention period and at longer
intervals thereafter – see Chapter 3), with follow-up of non-responders and telephone contact with fallers
to ascertain the type of fall and any injury and health-care usage that resulted.

For the purposes of the economic analysis, the resources used in the delivery of the interventions were
collected from records kept by PSI instructors (FaME) and the research staff and PMs (OEP). The use of
facilities and equipment, and the time spent on travel and instruction, were included and monetary costs
were assigned according to market rates.

In addition, the use of health and social care services (GP, community, outpatient, hospital admission) was
recorded for participants in all groups by means of the self-completion diaries. Self-reported service
utilisation was verified from the primary care medical records of consenting patients after the follow-up
period. Costs of services were obtained from local and national sources.62 Health and social care costs in
the exercise groups were compared with each other and with the usual-care (no exercise) group to
assess the extent to which the costs of the exercise intervention may be offset by savings elsewhere in the
health and social care system.

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
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 STUDY DESIGN, INCLUDING INTERVENTIONS

No other encouragement to continue with PA was given to participants, and all potential reinforcements in
the form of diaries and 6-monthly contacts were given to participants in all three arms of the trial. We
provided information about local exercise opportunities to all participants at the end of the intervention
period (i.e. 24 weeks after randomisation).

Baseline data collection

Baseline assessment included all functional assessments plus administration of all questionnaires
described above.

Follow-up data collection

Follow-up assessments occurred at 24 weeks after the commencement of the intervention, at 6, 12, 18
and 24 months after the completion of the intervention for participants in both intervention arms,
at 24 weeks after randomisation and at 6, 12, 18 and 24 months after completion of the 24-week
assessment in the control arm. The 24-week functional assessment was identical to the baseline
assessment plus administration of all questionnaires described above and administration of the Phone-FITT
questionnaire by telephone.

Assessments at 6, 12, 18 and 24 months after completion of the intervention or after completion of the
24-week assessment in the usual-care arm consisted of postal administration of the questionnaires
described above, plus the Phone-FITT questionnaire administered by telephone.

The primary outcome was the proportion of participants reaching the recommended PA target of at least
150 minutes of MVPA each week, measured using the CHAMPS questionnaire, at 12 months after
the intervention.

Sample size
Sample size estimates were based on the numbers of participants needed to detect differences in
proportions of participants in intervention and control groups:

1. participating in PA (defined as reaching the national target recommendations of five sessions of

≥30 minutes of at least moderate activity per week)
2. self-perceived health as measured by the EQ-5D index, from which mean QALY scores and the
incremental cost-effectiveness ratio (ICER) could be calculated.

Under individual randomisation, sample size calculations for a small effect size (0.3)63 equivalent to a mean
difference of 0.05 in the EQ-5D index in general community samples would have required 176 participants
per study group in an individually randomised trial.64 Published evidence of participants in a cluster
randomised trial of PA promotion shows the proportions of participants achieving the same recommended
targets for PA to be 14.6% (intervention subjects) compared with 4.9% (control subjects).65 A total of
215 participants in each study group would have been required to detect this difference between study
groups with 90% power (5% two-sided significance) in an individually randomised trial. Policy at the time
when the trial was designed sought a 1% increase in the number of people achieving the PA target of
five sessions of ≥30 minutes of at least moderate activity per week, year on year.1

Data from 24 general practices in the British Regional Heart study suggested that an intrapractice
correlation coefficient (ICC) not exceeding 0.02 was appropriate for PA outcomes among middle-aged
men, but this study aimed to represent the full range of cardiovascular disease prevalence across the UK
and the range was assumed to be less in the ProAct65+ study as it was less geographically dispersed.66
In addition, ICCs collected for a range of variables in primary care settings have typically averaged 0.01.67

Based on an intraclass correlation coefficient of 0.01, the design effect was estimated as 1.31, because
32 participants per practice were expected to provide data (see below). If 215 participants per arm
were to be required (before allowing for attrition) for an individually randomised design (90% power,

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

5% two-sided significance), then 282 per arm would be required for the clustered design. Allowing for
30% attrition, this equated to 403 participants per arm. The sample size was based on detecting
differences between each intervention (exercise programme) and the control arm: we did not expect
enough power to detect modest differences in outcome between the two intervention arms.

Assuming an average practice size of 6000 patients, 15% (900) of whom would be aged ≥65 years68
and that a random one in two sample of patients would be approached to take part in the study, we
calculated that 450 patients aged ≥65 years would need to be approached. Assuming a minimum of
10% of these patients agree to participate (approximately 45 per practice), and allowing for an attrition
rate of 30%, outcome data would be obtained on 32 participants per practice.

For small practices, we expected that all or most patients in each practice would be invited to join the trial. In
larger than average practices, however, where the patient list was very large, we anticipated that a stratified
random sample of 450 patients would be drawn. Response rates from each practice were recorded.

Randomisation
Owing to the relatively small number of practices in the trial, minimisation was used to allocate practices to
treatment arms to ensure maximum balance.69 After all participants from a practice had been recruited,
the practice was individually allocated to a study arm by the London co-ordinating centre. Practices were
given an identification number and treatments were assigned by the senior statistician for the trial using
computer-generated random number tables, embedded in a computer program for minimisation.
The variables used in the minimisation process were trial centre (London/Nottingham and Derby), practice
size (≥median practice size/<median practice size) and the index of multiple deprivation (IMD) 2007
(IMD2007)70 (≥median IMD2007/<median IMD2007). Minimisation was undertaken using the MINIM
program (www-users.york.ac.uk/~mb55/guide/minim.htm).71 Practice recruitment and allocation were
performed concurrently in the two centres. Median practice size and IMD2007 values for the whole of
England were used as cut-points for the minimisation process.

Concealment of allocation
Practices were allocated to intervention or usual care, only after all participants had been recruited.
The practices, their patients and the researchers undertaking baseline assessments were all blinded to
allocation until this point.

Blinding
It is difficult for participants to be blind in trials of exercise interventions and for researchers to remain blind
to the allocation of participants as they recruited them, or undertook baseline or follow-up assessments.
The researchers assessing outcomes were not blinded for pragmatic reasons alone; the study was funded
to support only enough researchers to carry our recruitment and follow-up simultaneously. However,
general practices and their participants, and researchers having contact with practices and participants, did
not have foreknowledge of the treatment arm allocation of the practice, which was not disclosed until
after all participants within a practice had been recruited.

Withdrawals
Participants could withdraw from the trial either at their own request or be withdrawn at the discretion
of the chief investigator after discussion with the chairperson of the trial steering committee (TSC).
Participants were made aware (via the information sheet and consent form) that withdrawal from the trial
would not affect their future care, and that the data collected to date may still be used in the final
analysis. Any requests to withdraw data made by individuals withdrawing from the trial were respected.
The research teams at each site advised discontinuation of exercise or withdrawal from the trial if the
exercise intervention posed a hazard to the safety of themselves or other participants. Those who
withdrew from the trial were not replaced.

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This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
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 STUDY DESIGN, INCLUDING INTERVENTIONS

Contamination
Usual-care arm participants may have been disappointed and might have sought their own way of
increasing PA, but the monthly diaries and the 6-monthly reviews should have captured this information.

Statistical methods
Characteristics of participants were compared with population norms at baseline (see Chapter 3). Linear
regression models were used for continuous outcome variables, logistic models for binary outcome
variables (in particular the primary end point, namely attainment of recommended exercise level at
12 months after the intervention), and negative binomial models for data on rate of falls. The assumptions
for using each model were checked and analyses adjusted accordingly. For a few quantitative outcome
measures found to have positively skewed distributions, logarithmic transformations were carried out. For
the outcome of minutes of MVPA, as measured by the CHAMPS score, there were a substantial number of
zeros in the data at each time point, so the MVPA values were transformed to loge(CHAMPS score+1).
Estimates of effects of each intervention against usual care were then back-transformed to provide an
estimate of the multiplicative effect of each intervention on MVPA. However, the primary outcome was
defined by dichotomising MVPA, whether or not it exceeded 150 minutes per week (as recommended by
guidelines), and binary logistic regression was applied.

All analyses were undertaken adjusted, (a) for variables used for minimisation (centre, deprivation and
practice size) and (b) for baseline values of the outcome measure. Multilevel models were applied to take
account of clustering at the practice level (applicable to all arms of the study). Our primary analysis focused
on participants with complete data at 12 months, but analysis using multiple imputation72 was also carried
out on the quantitative form of the primary outcome [loge(CHAMPS score+1)]. Some participants provided
Phone-FITT scores through telephone interview, even though they had not returned a questionnaire to
calculate a CHAMPS score. Therefore, imputation of the CHAMPS score at 12 months was first carried out
for those who provided a Phone-FITT score at 12 months. Second, all the variables in the analytical model
named above were entered into an imputation model for all participants, where all variables had missing
data imputed through chained equations. In each case, 50 imputed data sets were created, analysis carried
out and the 50 estimates of effects of the interventions were combined using Rubin’s rules.73 Differential
effects of the intervention by age and by sex were assessed for the primary outcome measure by adding
terms for the interaction between age (grouped into those aged<75 years and ≥75years at baseline) and
sex and treatment arm to the regression models. This analysis was confined to the quantitative form of the
primary outcome [loge(CHAMPS score+1)] to maximise power.

As the study consists of two intervention arms and one control arm, primary analysis consisted of
comparing each intervention group with the control group. No formal adjustment of p-values was made,
as the sample size had been specifically designed to test each intervention separately. Stata version 12
(StataCorp LP, College Station, TX, USA) and SPSS version 21 (IBM Corporation, Armonk, NY, USA) were
used for analyses, with the Stata mi command for multiple imputation. Multilevel analyses were carried out
using the xtmixed and xtmelogit commands in Stata for quantitative and binary outcomes, respectively,
and negative binomial regression was carried out in SPSS for the falls outcome.

Economic evaluation

An economic evaluation was conducted alongside the clinical trial. The predefined aims were to:

i. estimate the costs of the exercise interventions, from the NHS and participant perspectives
ii. explore the impact of the exercise interventions on participants’ utilisation of health and social services
during the 6-month intervention period, and for 12 months post intervention, to assess the extent to
which the costs of the interventions are offset by savings elsewhere in the system
iii. assess the cost-effectiveness of the interventions, compared with usual care (no exercise intervention),
using QALYs as the main measure of effectiveness.

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Data collection and analysis related to each aim are described separately, below.

Intervention costs

NHS perspective
The resources involved in the delivery of each intervention (OEP and FaME), and the physical amounts
used, were gathered from study records at each site (London and Nottingham/Derby). Resources fell into
four categories: set-up and management of the exercise interventions (appointment of PMs for OEP and
PSIs for FaME, securing venues for FaME exercise classes, organising staff reimbursements, etc.); hire of
facilities for FaME classes; procurement of exercise equipment, such as TheraBands, weights and mats;
human resources (cost of time input of PSIs) for FaME and PMs for OEP; and, travel and telephone
expenses associated with delivering the interventions. PSIs and PMs recorded all contacts with participants
on forms designed for the purpose. Resources associated with the research, such as recruiting participants
and gaining informed consent, were not included.

The interventions were delivered in 2010 and 2011, and full economic costs were calculated in British
pounds in 2011. Actual expenditures were used for the cost of non-human resources. PSIs were specifically
hired for the purposes of the research and paid a fixed fee per one-hour class of £50. In the costing
study, the cost of PSIs was based on the unit costs of an equivalent NHS grade, namely a community
physiotherapist. Two hours were allowed per class, to include preparation, clear up and travel time.
Use of unit costs has the advantage of taking account of salary on-costs, qualifications and management,
administrative and capital overheads.74 The value of volunteer PM time for OEP was established by
replacement cost methods using the unit cost to the NHS of community clinical support workers.73 The cost
of training PSIs and PMs in the FaME and OEP interventions (provided by the research team) was included.
The total cost of each intervention in each site was established and the cost per participant was calculated.

Private/participant perspective
Participants in all three groups reported out-of-pocket expenses related to exercising. This information was
collected in monthly diaries (six) during the 24-week intervention period, and in four subsequent diaries
with 3-month recall up to 18 months beyond the end of the intervention. They were asked to report if
they have bought anything to help them to exercise (e.g. special clothing such as stretchy trousers) and,
if so, what they bought and how much it cost. The diaries were also used for falls reporting and were
mailed back to the research team at the end of each reporting period. Diary data were collated at the
individual participant level and aggregated to provide total and average (per-participant) costs for each site
and study group.

The costs for participants in the FaME group of attending the group exercise venue were estimated from
information collected at the 24-week (end of intervention) postal assessment. A short structured form was
devised that asked them to report the distance they travelled (in miles, counting both ways); how long
they usually spent travelling to and from the exercise class (<15 minutes, 15–30 minutes, 30–45 minutes,
45–60 minutes, >1 hour); the mode of travel they usually used (train/tram/bus/taxi and fare both ways,
car and payment for parking or congestion charge, walk, other – specifying what method and cost per class).
This form also asked what other activity they gave up to attend the exercise class (work, caring, leisure,
etc.) to gain an indication of opportunity cost and the societal (productivity) effects. ProAct65+ targets
people aged ≥65 years and it was expected that many participants would be retired.

Service use
Exercise interventions have the potential to affect utilisation of health and social services in two ways.
First, exercise may result in general health benefits and therefore reduce other service utilisation and,
thereby, offset the cost of the intervention. Second, although designed to improve stability and reduce
falls, there is a possibility that additional engagement in exercise may increase the incidence of falls.
Monitoring falls, health and social care utilisation and costs associated with them was thus an important
component of the analysis of service use.

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 STUDY DESIGN, INCLUDING INTERVENTIONS

Health effects of exercise

Participants (all three groups) were asked to report at baseline their service use in the last month:
specifically how many times (0, 1, 2, 3 or 4, ≥5) in the last week they had visited their GP; had a home
visit from the GP; seen a nurse or other health professional at the GP surgery; had a home visit from a
nurse or other health professional; visited the hospital as an outpatient; stayed in hospital (number of
nights); bought or received prescribed medicines (number of items); not been able to do paid employment
or normal activities as a result of a health problem; had help at home from social care; and had needed
friends or relatives to help out at home. This information was used to compare groups at baseline.

Subsequently, service use data (same items as at baseline) were collected from participants in all groups
through the diaries (submitted monthly during the 6-month intervention and every 3 months thereafter
until 18 months post intervention). However, diary return was patchy, so a small pilot study was conducted
to explore the implications of collecting service use data from GP records (enabling all participants to be
included). Data were extracted for 27 participants (nine per study arm) for the 12 months prior to
recruitment and 18 months post recruitment, covering the same items as in the diary and with separate
documenting of service use related to physical injury and falls. The findings from this pilot study showed
(1) generally low numbers of contacts, except with GPs and other primary health-care professionals and
(2) that only a small proportion of recorded utilisation related to physical injury. It was therefore decided to
use GP records as the source of data on service use and to focus on primary care contacts (number of GP,
practice nurse, out-of-hours GP and other primary care contacts) at practice or clinic/home/by telephone.
Information on the number of falls, and service use associated with those falls [accident and emergency
(A&E) attendances, hospital admissions and number of inpatient nights] was also collected. All data
gathered from GP records covered the 18 months post recruitment (i.e. 6 months of the intervention and
12 months post intervention). Data were collected manually onto a specially designed proforma and
transferred to a SPSS database by a researcher working to a standard operating procedure.

Utilisation of each item of health and social care was recorded at the individual participant level and
aggregated to provide total and average (per-participant) utilisation for each site and study group. The
costs of health and social care utilisation were obtained by applying published unit cost data75 to physical
number of contacts for each service type. Group total and average costs were calculated for the 18-month
period post recruitment.

Falls
Falls were recorded in the study by two means. First, participants self-reported falls in diaries (according to
the same schedule as for service use): no fall versus fall with no injury, fall with bruise or cut, fall with
muscle or ligament injury, fall with broken bone. Reporting of any fall was followed up by the study team
for the purpose of AE reporting, but details of service use related to falls was not requested. Similarly,
the service use reported in diaries was not specifically related to the falls that were reported and could
refer to general health care that had been accessed. Secondly, data on falls [number, A&E attendances as
a result of falls, hospital admissions (and number of nights) as a result of falls], was collected as part of the
GP record extraction for the 18 months post recruitment. Concordance between the reporting of falls
for 53 participants in diaries and from GP records was explored. The findings showed good agreement for
people reporting no falls, but poor agreement where falls were reported. Of the 53, 16 had no diary data
or incomplete diary data. Of the 37 participants with both diary and GP data over the 12-month period,
there was disagreement between the sources regarding the number of falls for 10 records; in three of
these, the GP data recorded higher falls than the diaries, and in seven it was the other way round. Of the
27 cases where there was complete agreement between the GP and diary data, 25 were ‘nil’ returns
(i.e. no falls reported). On the assumption that falls giving rise to medical treatment are most consistently
likely to appear in the GP records, and as diary returns were incomplete, GP data were used in the
economic analysis as the primary source of information on service use associated with falls.

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

The number of falls, and A&E attendances and hospitalisations as a result of falls were collated at the
individual participant level and aggregated to provide total and average (per-participant) utilisation for each
site and study group. The costs of health and social care utilisation associated with falls were obtained by
applying published unit cost data74 to the number of A&E visits and hospital stays. Group total and
average costs were calculated for the 18-month period post recruitment.

Economic analysis

Standard techniques of economic appraisal were applied.76 The main measure of cost-effectiveness was the
mean difference in QALY scores at 12 months after the end of the intervention, after adjustment for baseline
measures in an analysis of covariance (as described in the statistical analysis section). Quality-adjusted life-year
scores were obtained by transforming SF-12 health-related quality-of-life scores into EQ-5D utility weights.
Transformation of SF-12 version 1 can be conducted using a published algorithm,40 but as version 2 had been
used in the study, an amended algorithm was obtained from the authors (Dr Oliver Rivero-Arias, Oxford
University, 2013, personal communication). The prepublished protocol specified that, if statistically significant
differences in mean-adjusted QALYs were found between groups at the primary end point, comparisons
between the usual-care (no exercise) group and each type of exercise programme would be conducted,
ICERs would be calculated, and a probabilistic sensitivity analysis undertaken.

Secondary cost-effectiveness analyses were conducted using the primary PA outcome [proportions in each
group reaching the recommended PA target of at least 30 minutes of activity of moderate intensity on at
least 5 days each week (150 minutes per week), measured using the CHAMPS and Phone-FITT
questionnaires] at 12 months after the end of the intervention.

The planned economic evaluation was based on NHS intervention costs only. Service use costs, and those
associated with falls, would be added to the analysis if significant differences in these variables were found
between groups.

Data sets
Missing outcome data were assumed to be ‘missing at random’, conditional on prespecified key predictors
of ‘missingness’ (in particular baseline values of the response variable, treatment arm and measures of
compliance post randomisation). Multiple imputation of outcome variables was carried out using these
predictors of missingness.77

The full analysis set comprised all randomised participants for whom one postbaseline assessment of the
primary outcome measure was available. The per-protocol set comprised all randomised participants who
are deemed to have no protocol violations. The safety set was all randomised participants who undertake
at least one OEP session or FaME class.

Risks
Participants completed a health questionnaire at recruitment which was sent to their GP to confirm
exclusion criteria, prior to commencement of either exercise programme. Previous evaluation of the OEP
showed significant reductions in falls and injuries.13 No adverse effects occurred in previous evaluations of
either the OEP or FaME programme.31

Safe exercise guidelines were followed, pre-exercise assessment was conducted and exercise intensity and
difficulty were increased with caution, to minimise the risk of injury. All participants and their GPs were
informed of the potential risk of injury from any exercise programme in the information documents
provided for participants and practices, so that consent was obtained with full knowledge of such risks.

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
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 STUDY DESIGN, INCLUDING INTERVENTIONS

Adverse events
An AE was defined as any unfavourable and unintended sign, symptom, syndrome or illness that develops
or worsens during the period of observation in the trial. This included:

1. exacerbation of a pre-existing illness

2. increase in frequency or intensity of a pre-existing episodic event or condition
3. condition detected or diagnosed after the intervention, even though it may have been present prior to
the start of the study
4. continuous persistent disease or symptoms present at baseline that worsen following the start of
the study.

A serious adverse event (SAE) was defined as any AE occurring following study-mandated procedures,
having received the OEP or FaME programme or usual treatment that results in any of the
following outcomes:

1. death
2. a life-threatening AE
3. inpatient hospitalisation or prolonging of existing hospitalisation
4. a disability/incapacity.

Important medical events that did not result in death, were not life-threatening and did not necessitate
hospitalisation were considered a SAE when, based on appropriate medical judgement, they jeopardised
the participant’s health and required medical or surgical intervention to prevent one of the outcomes listed
above. All AEs were assessed for seriousness, expectedness and causality. All AEs were recorded and
closely monitored until resolution, stabilisation, or until it had been shown that the study intervention was
not the cause.

Participants were asked to contact the trial site immediately in the event of any SAE. The chief investigator
was informed immediately and determined seriousness and causality in conjunction with any treating
medical practitioners. A SAE that was deemed directly related to, or suspected to be related to, the trial
intervention was reported to the TSC and the ethics committee.

Informed consent

Written informed consent was obtained from all participants. The decision regarding participation in the
study was entirely voluntary. The researcher emphasised to potential participants that consent regarding
study participation could be withdrawn at any time without penalty and without affecting the quality
or quantity of future medical care, or loss of benefits to which the participant was otherwise entitled.
No trial-specific interventions were undertaken before informed consent had been obtained.

Ethics committee approval

Ethical approval was granted to the trial from Nottingham Research Ethics Committee 2 (application
number 08/H0408/72). National Health Service Research & Development approval were granted by NHS
Nottinghamshire County and Westminster, Brent, Harrow, Hounslow and Barnet & Enfield PCTs,
and other relevant PCTs as practices were recruited to the study.

14
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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Management of the trial

A trial management committee made up of all co-applicants and research staff at each site met regularly,
face to face or by teleconference, to review the trial’s progress. Patient and public involvement (PPI) in the
study was ensured by involvement in the management group of two lay experts from Nottingham
University’s PPI forum. A combined TSC and data management committee met twice yearly to review
progress of the trial.

Summary

The ProAct65+ trial was a primary care-based exercise intervention for older people with wide inclusion
criteria. The pragmatic trial design replicated the approach taken in successful primary care trials in
New Zealand39 and differed from the majority of trials which focus on falls reduction in selected groups
by having continuation of PA as its primary outcome. The problems that we anticipated were (1) biases
in recruitment, with those already exercising at a relatively high level being more likely to volunteer for
this trial; (2) limited retention of recruits to the study, which we hoped to minimise by relatively frequent,
but brief, contact with participants after the end of the exercise programmes; (3) variation in ‘doses’ of
exercise, which we hoped to avoid through our quality assurance processes; and (4) an increase in falls
risk, as in previous studies,39 which we countered through training of staff, risk reduction and risk
management programmes.

Because the trial documented the levels of activity of participants (which could then be compared with
population norms), the number screened, the number who were ineligible and the number who refused,
its findings are generalisable, and can contribute to policy on exercise promotion and falls prevention
among older people. They are relevant to older people and to policy-makers working in health, social care
and leisure arenas, health and social care commissioners and providers, leisure providers and charities and
voluntary organisations working with older people.

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Chapter 3 Modification of trial processes

and procedures
T his chapter describes the challenges faced during the ProAct65+ trial and the modifications made to
the trial protocol.34

The protocol was amended in six main ways:

1. The number of practices was increased, the numbers invited from each practice were also increased,
and the recruitment period was extended, in order to recruit the target number of participants.
2. Telephone screening of possible participants prior to the initial assessment was introduced to exclude
those already exercising at, or above, the target level before they were given an appointment for the
baseline assessment.
3. The criteria for the recruitment of PMs for the OEP arm, and the intensity of their role, were changed in
an attempt to overcome problems of recruitment and retention.
4. A quality control system was incorporated into the FaME arm to aid standardisation of class activities.
5. The number of diaries participants were asked to complete during the follow-up period was reduced to
minimise the burden of diary completion and to optimise data collection about falls, service use
and costs.
6. An AE typology was developed and a system for checking it was applied consistently between sites,
to ensure governance of risks to participants.

Each of these changes will be summarised here and a detailed description can be found elsewhere.78

Improving the recruitment of general practices and participants

The flow path of participant recruitment to the trial is shown in Figure 1. The trial initially aimed to recruit
30 practices (15 at each site) and 45 patients per practice over a period of 3 weeks, to achieve a sample
size of 1200 participants aged ≥65 years. The proportion of those who expressed an interest varied
between practices, from 8% to 19% in London and from 7% to 21% in Nottingham/Derby, with a mean
of 13.4%. In order to achieve the recruitment target, the number of invitations to eligible patients was
increased from 450 per practice to 600 to adjust for the lower than anticipated recruitment, and more
practices were recruited.

Stratified random sampling was planned, whereby eligible patients would be stratified into age groups
65–74 years and ≥75 years. To simplify the tasks for the practices and to encourage their co-operation this
stratified sampling approach was abandoned and patients were sampled from one list of patients aged
≥65 years.

Room availability in practices for baseline assessments was limited and it took up to 6 weeks in some
practices to assess and recruit the target number of participants. The recruitment phase of the trial was
9 months longer than anticipated because of the need to recruit more practices at both sites and to allow
more time at each practice to undertake recruitment. This extension of the recruitment period altered the
time scale of the trial and potentially limited data collection for the 18- and 24-month follow-up. In total,
43 general practices and 1256 participants were finally recruited: 22 practices and 605 participants in
London and 21 practices and 651 participants in Nottingham/Derby.

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
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 MODIFICATION OF TRIAL PROCESSES AND PROCEDURES

Generating and cleaning practice lists using exclusion criteria to

shape searching of records

GPs asked to review lists to identify patients unsuitable for

invitation, using exclusion criteria and own judgement

Mailing to eligible patients with GP invitation and information

sheet

Expressions of interest returned to research groups in London

and Nottingham and Derby

Patient invited to have baseline assessment; telephone

screening to exclude those already physically active at target
level and frequent fallers

Baseline assessment and formal consent obtained

GPs asked to confirm suitability of those consented to joining

the trial

Practice allocated once all assessments complete

Patients informed of their allocation

Begin exercise interventions

Face-to-face post-intervention assessment at 24 weeks after

randomisation

Three-monthly diaries, postal and telephone follow-up at 6, 12, 18

and 24 months after closure of interventions

FIGURE 1 Flow chart of the recruitment and assessment process in the ProAct65+ trial.

Adding an eligibility screen

Although there were multiple steps for screening eligible patients (including electronic and manual patient
searches by the general practices), in the first practices recruited researchers encountered patients at the
baseline assessment and consent stage who were ineligible because they met exclusion criteria, particularly
falling fewer than three times in the previous 12 months or already exercising at the target level of five
sessions of 30 minutes of moderate exercise per week. To limit the number of assessments of participants
who would be found to be ineligible, researchers asked questions over the telephone about falls in the last
year and current levels of exercise when arranging the baseline assessment appointment, and excluded
those who met these criteria.

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Peer mentor recruitment and training

Volunteer PMs were recruited to support the participants during the exercise programme. Recruitment was
slow (Figure 2) and time-consuming. Despite intense efforts the number of PM who joined the trial did not
reach the target. After 8 months of PMs recruitment, the age criterion for PMs was altered to allow the
enrolment of adults aged ≥50 years. This led to an additional eight PMs being enrolled in London, but no
more in Nottingham/Derby.

Table 1 shows the length of time spent on recruiting PMs, numbers of individuals who expressed an
interest in becoming a PM, numbers of individuals trained, the number who subsequently disengaged from
the study, and the final number of PMs who volunteered and were allocated participants. There was a
large difference in the number of people who expressed an interest in becoming a PM and those that
were trained. Feedback from PMs suggests that disengagement was as a result of, in part, the length of
time between training and beginning work. This period was long because of the time needed to obtain
research management and governance approvals for the PMs, and because of the staggered recruitment
and randomisation of the practices. Disengagement was also as a result of, in part, the distance PMs
would need to travel to support participants.

Each PM in the trial mentored a mean of three participants (range 1–13) in London, and a mean of three
participants (range 1–5) in Nottingham/Derby. Overall, both sites fell short of the target of four to five
participants per PM. All participants, regardless of their PM support, received the initial exercise training

80

70
Number of peer mentors trained

60

50
London
40 Nottingham and Derby
Combined
30

20

10

0
1 4 7 10 13 16 19 22 25 28 31 34 37 40 43 46 49
Weeks

FIGURE 2 Number of PMs trained.

TABLE 1 Time scale of PM recruitment

Time scale and recruitment London Nottingham/Derby

Time spent on recruitment by staff (months) 12 15

Expressed interest (n) 130 79

Trained (n) 50 21

Disengaged (n) 19 14

Volunteered (n) 31 7

Time from trained to deployed (days) Mean 132 (range 21–255) Mean 155 (range 75–257)

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
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 MODIFICATION OF TRIAL PROCESSES AND PROCEDURES

session and a booklet with tailored exercise instructions. Not all participants received a PM because of the
difficulties recruiting them. In London, 123 (53%) participants and in Nottingham/Derby, 21 (12%)
participants had a PM.

Despite using the same recruitment methods, recruitment difficulties were greater in Nottingham/Derby,
possibly because the trial was competing with existing PM PA programmes for older people in
Nottingham/Derby. The TSC advised to keep the intervention true to usual practice in the NHS, i.e. one
instruction session plus a manual of exercises. Therefore, where there were insufficient PMs for all
participants, they were not supplemented by an alternative person and some participants had no PM
support at all.

In another attempt to increase the number of PMs and encourage them to support more participants,
the number of their supportive contacts with participants was reduced. Initially PMs were scheduled to
visit participants in their home on four occasions and telephone them 12 times during the 24-week
intervention. This was reduced to two visits and eight telephone calls. Over both sites, the number of
home visits ranged from zero to five (mean 2) and the number of telephone call contacts ranged from 0 to
18 (mean 6). Modification of the number of contacts did not increase PM recruitment or their case load.

Quality control of the Falls Management Exercise programme

The FaME intervention was a weekly group-based exercise session, supplemented with additional home
exercises (modified from the OEP) described in a booklet. Postural stability instructors were recruited to
lead the classes. The trial aimed to recruit 12 PSIs per site. In London, 16 PSIs were recruited, with a total
of seven working on the trial. As there were few qualified PSIs available to recruit in Nottingham/Derby,
the trial recruited and trained physiotherapists and exercise professionals who were interested in becoming
a PSI and working on the trial. Sixteen individuals embarked on the PSI training course (15 completed the
training) and seven of them worked on the trial. Some PSIs were not employed on the trial because of
their limited availability. Additionally the complex and lengthy process of completing research governance
approvals resulted in losing some available PSIs. The recruitment target was reached with 32 PSIs recruited
and trained over both sites. Of these, 14 (44%) delivered the intervention, enabling the intervention to be
fully staffed.

In order to quality assure and standardise the FaME intervention, two quality assurance members of the
trial oversaw the intervention delivery by attending four exercise sessions over the 24-week intervention
period for each PSI in all of the FaME practices. The quality assurers went to the sessions individually,
except the first two sessions when they attended together to standardise their method. Overall, 45 FaME
classes in London and 38 in Nottingham/Derby were quality assured. Using a standard checklist (Figure 3),
the quality assurers observed the PSI leading the exercise class and then gave them feedback and an action
plan in order to improve intervention delivery, optimise participants’ ability to undertake progressively
demanding exercises and standardise the exercise intervention as much as possible.

Measuring falls, service use and physical activity

During the intervention self-completion diaries were posted to participants every 4 weeks. During the
follow-up period, participants were posted self-completion diaries every 3 months, larger self-completion
questionnaires every 6 months and telephoned for a short questionnaire every 6 months. See Table 2 for
the schedule of questionnaires at different time points and Chapter 2 for full details of questionnaires.

Because non-monetary incentives are known to assist retention in trials,17 small incentives were sent to
participants to encourage completion of postal questionnaires. With diary 6 and 12, participants received a

20
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 PSI Name QA visit number______ QA visit date Venue Name of observer

SO16 7NS, UK.

Key: √ item noted; * comment; Q question; S needs support

Preparing Teaching

Warm-up
endurance
Dynamic
Balance
Dynamic
Standing
Seated/
Chaining
Backward
Floor work
Flexibility
Cool-down
Cool-down
Adapted Tai Chi
DOI: 10.3310/hta18490

1 Arrived in time to meet participants 13 Engaged participants in order to motivate and promote confidence

2 Completed safety check on venue 14 Selected safe and effective exercises appropriate to the component.
Selected safe and effective exercises appropriate to the stage
3 Wore attire appropriate to the activity 15 in the intervention

4 Appropriately arranged the group, individuals and resources 16 Selected the appropriate speed for the exercises

5 Welcomed participants 17 Gave effective visual and verbal instructions

Provided specific relevant teaching points to enhance technique,
6 Took register of attendance 18 effectiveness and postural stability
Verbally screened participants for falls, previously reported injuries and new or known Reinforced the specific relevant teaching points at
7 medical conditions 19 regular intervals
Provided safe transitions between exercises and
8 Appropriately followed up returners after period of absence 20 session components
Demonstrated and performed exercises accurately and with
9 Reminded attenders to keep up with and submit diaries 21 good posture
Changed teaching position to improve observation and
10 Ensure that infection control procedures are implemented and adhered to 22 enhance communication

11 Ensure that confidentiality of personal and medical data is respected Provide home exercise packs 23 Demonstrated the use of observation and effective correction
and remind participants to practice the home exercises Explained the purpose of the exercises, relating them to postural
12 24 stability and daily life
Encouraged interactive communication, to check or clarify
Liaison with research team 25 understanding, with group and one tone.

29 Submitted completed register on time 26 Spoke clearly, audibly and at an appropriate pace
Adapted exercises to meet the needs of participants with postural
30 Evidence of telephone follow-up of non-attenders 27 stability challenges
Offered alternatives to allow for different levels of ability/tailored
31 Patients submitting diary data at levels similar to other classes 28 exercises to individuals

32 This class attendance data similar to other classes?

FIGURE 3 Postural stability instructors quality assurance checklist.

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HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

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21
 MODIFICATION OF TRIAL PROCESSES AND PROCEDURES

TABLE 2 Schedule of questionnaires used during the ProAct65+ trial

Face-to-face, telephone
and postal assessments Telephone and postal assessments

End of
intervention
Outcome and tool Baseline (24 weeks) 6 months 12 months 18 months 24 months

PA

Subjective habitual PA (Phone-FITT, O, F, U O, F, U O, F, U O, F, U O, F, U O, F, U

PASE and CHAMPS)

Self-completed exercise diaries O, F, U O, F, U O, F, U O, F, U O, F, U O, F, U

(4-weekly during intervention and
then 3-monthly during follow-up)

Direct health benefits

Modified Clinical Romberg Static O, F, U O, F, U
Balance test

TUG O, F, U O, F, U

Functional reach O, F, U O, F, U
30-second chair rise O, F, U O, F, U

Falls risk (FRAT) O, F, U O, F, U

Falls (falls dairies 4-weekly during O, F, U O, F, U O, F, U O, F, U O, F, U O, F, U

intervention, 3-monthly during
follow-up)

ConfBal scale O, F, U O, F, U O, F, U O, F, U O, F, U O, F, U

FES-I O, F, U O, F, U O, F, U O, F, U O, F, U O, F, U
Social network size and density O, F, U O, F, U O, F, U O, F, U O, F, U O, F, U
(brief LSNS) and perceived social
support (MSPSS)

Quality of life

Quality of life (OPQoL and SF-12) O, F, U O, F, U O, F, U O, F, U O, F, U O, F, U

Stage of change, self-efficacy for exercise, physical self-perception and value or importance of PA

Self-efficacy for exercise O, F, U

AFRIS O, F
Demographic information, O, F, U O, F, U
medication

Comorbidity O, F, U

Use of primary, secondary care O, F, U O, F, U O, F, U O, F, U O, F, U O, F, U

and social care services from
falls diaries
F, FaME arm; O, OEP arm; U, usual-care arm.

22
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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

ProAct65+ pen and with diary 8 and 10, they received a ProAct65+ cotton shopping bag. Participants
were also sent an annual Christmas card and brief newsletters with each diary they received.

Research staff at both sites telephoned participants every 3 months to remind them to return
questionnaires. Up to three contacts with participants were made to undertake each telephone interview.
Some participants did not return self-completion diaries and/or questionnaires and some were not available
for a telephone interview as a result of a variety of reasons, including being on holiday, at work, too busy,
or forgetting or losing the questionnaires.

The self-completion diaries requested information on participants’ health and social service use, falls and
current exercise levels.79 Initially, it was planned for participants to receive monthly prospective diaries to
complete throughout the full length of the trial. When participants said that they wished to withdraw from
the trial because of the quantity and frequency of questionnaires they were offered the opportunity to
remain in the trial but complete only the 6-monthly questionnaires and not receive further diaries. By doing
this, the trial retained 52 participants in London and 28 in Nottingham/Derby (6% of total trial participants)
who would otherwise have withdrawn from the trial. To further limit the number of participants who
withdrew from the trial because of the burden of the questionnaires and diaries the frequency of the
diaries sent during the 2-year follow-up phase was reduced from monthly to quarterly. The diaries sent
during the follow-up phase required the participants to recall their service use and falls from the last
3 months and record a 1-week prospective snap-shot of their exercise activities.

Capturing adverse events

Adverse events were monitored throughout the trial to assess the trial’s safety and manage participant
risks. This is especially important as exercise within this age group may be associated with an increased risk
of falls.39,80 The ProAct65+ trial used a risk management pathway for capturing, classifying and dealing
with participant AEs (Figure 4), which initially categorised all occurrences as SAEs, AEs, adverse reactions
(ARs) or adverse incidents (AIs). All data were logged and any SAEs were reported to the TSC. The original
risk management pathway and the definitions of events, reactions and incidents are reported in the
trial protocol.34

A comparison of all events between trial sites was carried out towards the end of the trial’s intervention
phase. There were noticeable differences in the numbers of ARs recorded between sites with London
categorising 5%, and Nottingham/Derby categorising 16% of their total events as ARs. A cross-checking
system was therefore implemented between sites in an attempt to standardise categorisation. All events
from each site, except AIs, were checked by the other site. If the other site’s categorisation was different
to the original categorisation, this was deemed a mismatch. Mismatches between sites were identified,
and blinded forms then passed to the principal investigators who discussed and agreed a final
categorisation. The initial calculation of mismatches was performed towards the end of the intervention
phase, when there were 51 mismatches, giving a mismatch rate between sites of 19%.

The decision whether or not an event is ‘possibly related’ to the trial is open to subjective interpretation.
Consequently, 45 of the 51 (88%) discrepancies in the categorisation of events recorded at each site were
between AEs and ARs. The category ‘possible adverse reaction’ (possible AR) was therefore added. After
the introduction of the possible AR category, the mismatch rate (prior to discussion between principal
investigators) fell to 2.6%.

After advice from the TSC, the categorisation was further modified to enable unrelated SAEs to be
distinguished from non-SAEs. The final categories applied to the trial’s events were, therefore, SAEs,
unrelated SAEs, AEs, ARs, possible ARs and AIs (see Figure 4).

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 MODIFICATION OF TRIAL PROCESSES AND PROCEDURES

1. Characterise AE
Any member of trial
• Circumstances surrounding
team learns about
occurrence
AE from any source

AEs do not include

falls that require no 2. Site lead determines if event is
medical attention. serious, consulting CI as necessary
However, these are • Death
recorded as ADVERSE • Non-elective hospitalisation
INCIDENTS in the
AE log

Serious Not serious

CI takes appropriate If patient has not sought

medical action as needed, medical attention, site lead
including notifying GP if encourages him or her to do
not already aware so, including notifying GP

3. CI determines causality 3. CI determines causality

of AE of AE

Possibly, probably, or Not related or Possibly Probably, or Not related or

definitely related improbably related related definitely improbably
related related
POSSIBLE
UNRELATED
RELATED SAE ADVERSE ADVERSE REACTION UNRELATED AE
SERIOUS
REACTION

Complete SAE form Complete AE form and record in AE log

CI reports occurrence Site lead reviews Take actions as

of event to ethics patient’s status and necessary to modify
committee and trial makes decision with conditions of
steering committee him/her about intervention
within 7 days continued participation

FIGURE 4 The ProAct65+ risk management pathway. CI, chief investigator.

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Chapter 4 Recruitment of practices,

postural stability instructors, peer mentors
and participants

Recruitment of general practices

Forty-three practices were recruited to the trial, to ensure that the target study population could be
reached (see Chapter 3 for details). The characteristics of practices that joined the trial are shown
in Table 3.

Postural stability instructors

The target of recruiting 12 PSIs per site was achieved and FaME-arm classes were fully staffed. In London,
16 PSIs were recruited with a total of seven working on the trial, whilst in Nottingham/Derby 15 completed
the training, and seven of them worked on the trial. The mean class size was less than planned, at five not
nine. The quality assurance reviewers noted that PSIs largely achieved standardisation of the intervention,
although they varied most in progression of the exercise programme, and needed reminding about
collecting data for the trial.

Peer mentors

Thirty-eight PMs were recruited, trained and deployed in the trial, 31 in London and seven in the
Nottingham/Derby practices (details of the recruitment processes can be found in Chapter 3). The planned
and actual engagement by PMs with participants is shown in Table 4. Research staff carrying out quality
assurance through discussions with PMs concluded that, as a whole, PMs made only a limited attempt to
standardise the intervention (i.e. to implement the individualised plan given to the participant at the first
encounter) and the participants’ progression was also limited, even though the PMs tailored their advice in
other aspects of exercise. They returned trial paperwork (follow-up sheets detailing call and visit
information, and time and travel log for the economic analysis) promptly.

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 RECRUITMENT OF PRACTICES, POSTURAL STABILITY INSTRUCTORS, PEER MENTORS AND PARTICIPANTS

TABLE 3 Characteristics of practices in the ProAct65+ trial

Practice (n=43) characteristics Number (%) or median (IQR)

Training practices 24 (55.8)

Number of GPs 4 (3–7)

Number of nurses 2 (1–3)

Use of exercise referral scheme 32 (76.2) [1]

IMD2007 scorea 20.98 (14.50–34.97)

List size 6532 (4046–8509)

Number of patients aged ≥65 years 895 (495–1390)

IQR, interquartile range.
a The IMD2007 combines a number of indicators, chosen to cover a range of economic, social and housing issues, into a
single deprivation score for each small area in England.
Number of practices with missing data represented with [ ].

TABLE 4 Planned and actual contacts between PMs and trial participants in the OEP arm

Contacts Planned Actual Duration

Home visits 2 Mean 2 (range 0–5) 25–95 minutes, median 38.5 minutes

Telephone calls 8 Mean 6 (range 1–18) 3– 20 minutes, median 5.0 minutes

Recruitment of participants

Steps that were taken to ensure recruitment to the trial are described in Chapter 3. Figure 5 shows the
recruitment of 1256 participants to the study. In total, 20,507 patients were invited to participate
(Nottingham/Derby, 10,738; London, 9769). Expressions of interest were received from 2752 (13%)
(Nottingham/Derby, 1481; London, 1271) and 1256 (6% of those approached) consented (Nottingham/
Derby, 651; London, 605).

Baseline characteristics of the study population

The average age of participants was 73 years (range 65–94 years), with 84% of participants aged less than
80 years, and 62% of participants were female. Thirty-four languages were spoken (33 in London and
12 in Nottingham/Derby) and 14% of participants were non-white, with greater ethnic diversity among the
London participants. A total of 44% of participants had completed some form of further education, as
shown in Figure 6. On average, each participant had 1.7 comorbidities [range 0–7, standard deviation (SD)
1.4 comorbidities] and was taking 3.7 medications on repeat prescription (range 0–18, SD 3.7 medications).

Baseline characteristics of participants in the trial are compared with normative data in Table 5. Trial
participants performed below normative levels on most scales, except for Phone-FITT, PASE, ConfBal and
OPQoL, but similarly to normative values on the AFRIS questionnaire. The normative values for
Phone-FITT apply to an older (mean age 81 years) male population, so the higher level of household PA
and the lower level of recreational activity in the ProAct65+ population may reflect its lower median age
and the predominance of female participants. The normative values for ConfBal were calculated from the
published data, which were derived from a population attending day centres, so the better performance
of trial participants is not surprising.

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Predicted biweekly accrual

Actual cumulative accural
Actual biweekly accrual

*
Cumulative accrual
1400

1200

1000

800

600

400

200

0
2 4 6 8 0 2 4 6 8 0 2 4 6 8 0 2 4 6 8 0 2 4 6 8 0 2 4 6 8 0 2 4 6 8 0 2 4
d d d d 1 1 1 1 1 2 2 2 2 2 3 3 3 3 3 4 4 4 4 4 5 5 5 5 5 6 6 6 6 6 7 7 7
an an an an andand and andandandand and andand andand andandand andand andand andandand andand and andandand andand andand and
* * *

1 3 5 7 9 1 3 5 7 9 1 3 5 7 9 1 3 5 7 9 1 3 5 7 9 1 3 5 7 9 1 3 5 7 9 1 3
1 1 1 1 1 2 2 2 2 2 3 3 3 3 3 4 4 4 4 4 5 5 5 5 5 6 6 6 6 6 7 7
* * *
*
*
*

Weekly accrual from start of study

*
*
*
*
*
*
*
*
*
*
*
*
*
*
*

FIGURE 5 Recruitment of participants to the trial.

* *
*
*
*
*
*
* *
* * 0
60

40

30

20

10
50
80

70

Number of patients consented weekly

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
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 RECRUITMENT OF PRACTICES, POSTURAL STABILITY INSTRUCTORS, PEER MENTORS AND PARTICIPANTS

University Primary
school
(22%)
(4%)

Secondary
school
(52%)

FE college
(22%)

FIGURE 6 Educational attainment among trial participants. FE, further education.

TABLE 5 Baseline measures compared with normative data

Normative
Outcome measure ProAct65+ mean (SD) Normative mean (SD) reference
TUG 11.08 seconds (5.94 seconds) 9.4 seconds (95% CI 8.9 to Bohannon
9.9 seconds) 200681
30-second chair rise 10.40 stands (3.26 stands) Rikli 199944

Women 10.03 stands Women 12.7 stands

(3.02 stands) (4.0 stands)

Men 11.06 stands Men 14.2 stands

(3.54 stands) (4.6 stands)

Functional reach 25.46cm (8.03cm) Duncan 199043

Men 26.34cm (8.38cm) Men 33.43cm (1.55 cm)

Women 24.93cm (7.77cm) Women 26.59cm

(3.53 cm)

Romberg test (scored out of 28) 20.19 (6.98) None published as a score

FRAT (scored out of 5, ≥3 high risk Mean score not useful. Does not state what % of Nandy 200460
of future fall) Proportion at high risk=6% recruited population
scored ≥3

SF-12 Physical summary score Physical summary Ware 199661

36.90 (6.59) score 47.42±0.40

Mental summary score Mental summary

48.76 (6.29) score 53.82±0.30

Phone-FITT 39 (14) Gill 200856

(population is
Household PA score Household PA score male, mean age
26.28 (9.86) 19.2 (9.0) 81 years)
Recreational PA score Recreational PA score
12.30 (8.42) 14.9 (11.3)
CHAMPS Calorific expenditure per week Calorific expenditure per Stewart 200120
in at least moderate intensity week in at least moderate
physical activities 915 intensity physical activities
(1306) calories 1486 (1472) calories
Frequency per week in at least Frequency per week in at
moderate intensity physical least moderate intensity
activities 2 (4) physical activities 5.7 (4.5)

28
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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

TABLE 5 Baseline measures compared with normative data (continued )

Normative
Outcome measure ProAct65+ mean (SD) Normative mean (SD) reference

Calorific expenditure per week Calorific expenditure per

in all listed physical activities week in all listed physical
2238 (2136) calories activities 2420
(1831) calories

Frequency per week in all Frequency per week in all

listed physical activities 10 (11) listed physical activities
13.1 (8.0)

PASE (total score) 117 (61) 102.9 (64.1) Washburn

199357
AFRIS (range for each item 1–7, Group exercise median Median Yardley 200746
high score is good)
Attitude, 5.5 Attitude, 5.5

Subjective norm, 6.0 Subjective norm, 5.5

Perceived behavioural control, Perceived behavioural

5.0 control, 6.0

Identity, 5.0 Identity, 6.0

Intention, 7.0 Intention, 6.0

Home exercise median

Attitude, 5.0

Subjective norm, 6.0

Perceived behavioural control,

6.0

Identity, 5.0

Intention, 6.0

ConfBal (scored between 10 and 30, 12.55 (3.887) 17.59 (not published – SG Simpson 200945
low score is good) calculated from their data) (population
attending
day centres)

FES-I (range for each item=1–4, Item 1 1.18 (0.54) Item 2 1.50 (0.81) Yardley 200559
1=not at all concerned, 4=very
concerned, items are matched by Item 2 1.37 (0.72) Item 4 2.09 (1.09)
question although item Item 3 1.14 (0.49) Item 6 1.49 (0.79)
numbers differ)
Item 4 1.44 (0.76) Item 7 2.06 (1.08)

Item 5 1.41 (0.75) Item 9 2.14 (1.11)

Item 6 1.34 (0.69) Item 15 2.46 (1.16)

Item 7 1.18 (0.54) Item 16 1.85 (1.06)

MSPSS (average score) 5.50 (1.37) 6.40 (0.75) Stanley 199882

OPQoL (total score) 129.87 (13.27) 114.538 (10.718) Bowling 200983

CI, confidence interval.

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This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
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 RECRUITMENT OF PRACTICES, POSTURAL STABILITY INSTRUCTORS, PEER MENTORS AND PARTICIPANTS

Retention of participants
Of the 1256 randomised study participants, 426 (33.9%) did not reach 12 months’ follow-up after the
end of the intervention period. Of these, 69 were excluded by their GP, 12 died, three withdrew at an
unknown time point, one withdrew before providing any baseline data and one withdrew but asked for
their data to be destroyed. Overall, 340 participants were defined as lost to attrition. Almost half of these
dropouts withdrew within the first 3 months of the intervention (49.7%). A total of 830 participants were
retained in the trial at 12 months’ follow-up. Figure 7 summarises the pattern of attrition over time, for all
arms and sites.

Illness events were common in this study population and 30% of those who dropped out cited illness
(their own or others’) as their reason for discontinuing with the study. Disappointment at allocation and
research burden (principally related to the number of questionnaires and diaries to complete) were
responsible for at least 18% and 11% of dropouts, respectively.

Tables 6 and 7 describe participants’ characteristics by withdrawal status. Associations of baseline

measures with later withdrawal were investigated using logistic regression, with robust standard errors
calculated to allow for clustering of participants within practices.

Those participants who dropped out were significantly more likely to be older, have three or more
comorbidities, have more medications, have a lower level of education, have worked or currently work in
a routine or manual occupation, be an ex-smoker, be unable to rise from a chair of knee height, be less
confident about their balance, have a high concern about falling, be inactive, perceive their physical
health as poor, be at risk of social isolation, have a lower subjective quality of life, have lower outcome
expectations for exercise, take longer than 13.5 seconds to complete the TUG test, have a reduced
functional reach, score lower on the Romberg test and perform fewer sit to stands in 30 seconds.

30
NIHR Journals Library www.journalslibrary.nihr.ac.uk
 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

43 practices recruited

Number of people aged 65+ years invited

(n = 20,507)

Expressions of interest
(n = 2752)

Consented + baseline assessment

(n = 1256)

Randomisation of practices

FaME OEP Usual care

(n = 387 ) (n = 411 ) (n = 458 )

Lost to follow-up Lost to follow-up Lost to follow-up

• At allocation, n = 33 • At allocation, n = 27 • At allocation, n = 38
• GP excluded, n = 32 • GP excluded, n = 13 • GP excluded, n = 124
• Died, n = 3 • Died, n = 3 • Died, n = 4
• Through illness, n = 29 • Through illness, n = 43 • Through illness, n = 26
• Research burden, n = 12 • Research burden, n = 15 • Research burden, n = 30
• Other reasons, n = 20 • Other reasons, n = 17 • Other reasons, n = 10
• Not known, n = 18 • Not known, n = 40 • Not known, n = 56

FaME 12 months OEP 12 months Usual care 12 months

post intervention post intervention post intervention
(n = 240) (n = 253) (n = 270)

Had 12 months CHAMPS or Had 12 months CHAMPS or Had 12 months CHAMPS or

Phone-FITT Phone-FITT Phone-FITT
(n = 240) (n = 253) (n = 270)

Only Only Only

Phone-FITT Phone-FITT Phone-FITT
(n = 47) (n = 68) (n = 48)

CHAMPS CHAMPS CHAMPS

(n = 193) (n = 185) (n = 185)

Missing Missing Missing

baseline baseline baseline
CHAMPS CHAMPS CHAMPS
(n = 9) (n = 7) (n = 12)

All data for primary analysis All data for primary analysis All data for primary analysis
(n = 184) (n = 178) (n = 210)

FIGURE 7 The CONSORT diagram.

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 RECRUITMENT OF PRACTICES, POSTURAL STABILITY INSTRUCTORS, PEER MENTORS AND PARTICIPANTS

TABLE 6 Univariate associations between attrition and sociodemographic dataa

Characteristics Retained Withdrew OR (95% CI) p-value

Number of participants (n=1170) 830 (70.9) 340 (29.1)

Sex (% female) 518 (62.4) 219 (64.4) 1.09 (0.90 to 1.32) 0.380

Age (years) median (IQR) 71 (68–76) 74 (69–79) 1.05 (1.03 to 1.08) <0.001

Group allocation

FaME 256 (30.8) 95 (27.9) 1.00 0.750

OEP 278 (33.5) 114 (33.5) 1.11 (0.77 to 1.58)

Usual care 296 (35.7) 131 (38.5) 1.19 (0.74 to 1.92)

BMI (kg/m2) mean (SD) 26.7 (4.9) [20] 27.2 (5.1) [26] 1.02 (0.99 to 1.05) 0.140

Number of comorbidities [1]

0 comorbidities 157 (18.9) 46 (13.5) 1.00 0.007

1 or 2 comorbidities 404 (48.7) 157 (46.2) 1.33 (0.90 to1.96)

≥3 comorbidities 268 (32.3) 137 (40.3) 1.74 (1.22 to 2.49)

Number of current medications median (IQR) 3 (1–6) [5] 4 (2–6) [3] 1.06 (1.02 to 1.10) 0.004

English main language 738 (89.9) [9] 290 (86.3) [4] 0.71 (0.50 to 1.01) 0.060

White self-reported ethnicity 707 (87.2) [19] 291 (86.6) [4] 0.95 (0.67 to 1.34) 0.780

Living alone 285 (34.6) [5] 122 (35.9) 1.06 (0.78 to 1.44) 0.710

Children <18 years living at home 8 (1.0) [2] 6 (1.8) 1.84 (0.68 to 4.98) 0.230

Living with dependent adults 40 (5.0) [35] 27 (8.2) [9] 1.68 (0.95 to 2.95) 0.073

Education [13] [3]

Primary/secondary school 436 (53.4) 206 (61.1) 1.00 0.030

College/university 381 (46.6) 131 (38.9) 0.73 (0.55 to 0.97)

Employed full- or part-time 69 (8.4) [8] 33 (9.7) [1] 1.18 (0.76 to 1.82) 0.470
b
NS-SEC job grade [35] [15]

1–2: managerial and professional occupations 354 (44.5) 125 (38.5) 1.00 0.047

3–4: intermediate occupations 229 (28.8) 84 (25.9) 1.04 (0.76 to 1.41)

5–7: routine and manual occupations 205 (25.8) 109 (33.5) 1.51 (1.08 to 2.11)

8–9: never worked and long-term unemployed 7 (0.9) 7 (2.2) 2.83 (1.01 to 7.95)
Annual household income ≥£20,000 291 (40.1) [104] 110 (40.0) [65] 1.00 (0.75 to 1.32) 0.980

Smoking status [2]

Non smokers 444 (53.6) 148 (43.5) 1.00 0.011

Ex-smokers 341 (41.2) 172 (50.6) 1.51 (1.15 to 1.99)

Current smokers 43 (5.2) 20 (5.9) 1.40 (0.70 to 2.76)

CI, confidence interval; IQR, interquartile range; NS-SEC, National Statistics Socio-Economic Classification; OR, odds ratio.
a Data are n (%) [n missing], unless otherwise stated.
b Current or previous job coded to the National Statistics Socio-economic Classification 2000.
Note
A total of 69 participants were withdrawn by their GP after allocation, two withdrew their data from the study and 15 had
incomplete demographic data.

32
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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

TABLE 7 Univariate associations between attrition and risk factors for falling, exercise, psychosocial and
functional measuresa

Unadjusted
Characteristics Retained Withdrew OR (95% CI) p-value

Number of participants (n=1170) 830 (70.9) 340 (29.1)

Use public transport easily 788 (95.6) [6] 312 (92.3) [2] 0.55 (0.30 to 1.01) 0.052

Use a walking aid 112 (13.5) [2] 51 (15.0) [1] 1.13 (0.78 to 1.64) 0.520
b
FRAT

History of any fall in the 134 (16.2) [1] 67 (19.8) [1] 1.28 (0.94 to 1.75) 0.120
previous year

On ≥4 medications per day 361 (43.6) [1] 174 (51.3) [1] 1.37 (1.07 to1.75) 0.014

Diagnosis of stroke or 14 (1.7) [1] 12 (3.5) [1] 2.14 (0.91 to 5.03) 0.082
Parkinson’s disease

Any self-reported problems with 197 (23.9) [5] 83 (24.8) [5] 1.05 (0.80 to 1.38) 0.730
their balance

Unable to rise from a chair of 25 (3.0) [3] 19 (5.6) [3] 1.92 (1.01 to 3.63) 0.046
knee height
ConfBal score median (IQR)c 10 (10.0–13.0) [81] 12 [10–15) [82] 1.08 (1.05 to 1.12) <0.001

High concern about falling (measured 123 (16.3) [74] 64 (24.2) [75] 1.64 (1.15 to 2.34) 0.007
by short FES-I)d

CHAMPS (minutes/week MVPA)e [64] [70]

0 minutes 163 (21.3) 99 (36.7) 1.00 <0.001

1–149 minutes 274 (35.8) 82 (30.4) 0.49 (0.35 to 0.70)

≥150 minutes 329 (43.0) 89 (33.0) 0.45 (0.32 to 0.62)

SF-12 PCS mean (SD) f

37.6 (6.2) [4] 36.3 (6.9) [2] 0.97 (0.95 to 0.99) <0.001
g
SF-12 MCS mean (SD) 48.7 (6.1) [3] 48.4 (6.7) [2] 0.99 (0.97 to1.02) 0.540
h
Socially isolated (based on LSNS-6) 149 (20.0) [85] 72 (27.4) [77] 1.51 (1.06 to 2.15) 0.023

Perceived social support (MSPSS) 70 (58.0–79.0) [130] 70 (55.0–78.0) [95] 0.99 (0.99 to1.00) 0.250
median (IQR)i

OPQoL mean (SD)j 131.0 (13.0) [169] 126.9 (13.8) [126] 0.98 (0.96 to 0.99) <0.001

OEE-positive subscale median (IQR)k 3.9 (3.6–4.2) [107] 3.8 (3.4–4.2) [93] 0.78 (0.62 to 0.98) 0.035
CI, confidence interval; LSNS-6, Lubben Social Network Scale-6; MCS, mental component summary; OR, odds ratio; PCS,
physical component summary.
a Data are n (%) [n missing], unless otherwise stated.
b FRAT is a five-item tool used to assess falls risk. The presence of ≥3 risk factors indicates a higher risk of falling.
c ConfBal scale: total score provided as a measure of confidence, range from confident ‘10’ to ‘30’ not confident.
d The short FES-I dichotomised into low (score 7 to 10) or high (score ≥11) concern about falling.
e CHAMPS is a 40-item scale measuring PA duration and frequency in older people.
f SF-12 PCS scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scale
and 100 indicates the highest level of health.
g SF-12 MCS scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scale
and 100 indicates the highest level of health.
h LSNS-6 where a score of ≤11 indicates the participant is isolated.
i MSPSS is a 12-item scale measuring perceived availability of support. Scores range from 12 (weak social support) to 84
(strong social support).
j OPQoL range 33–165 (higher score implies a higher subjective quality of life).
k OEE scores range from 1 to 5, with 1 indicative of low outcome expectations for exercise, and 5 strong outcome
expectations for exercise.

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Chapter 5 The primary outcome and safety

T he primary outcome (see Chapter 2) was the proportion of participants achieving or exceeding the PA
target of 150 minutes of MVPA per week. In this analysis, we dichotomised CHAMPS scores, according
to whether or not MVPA exceeded 150 minutes per week. Table 8 and Figure 8 demonstrate that the
proportion achieving or exceeding the MVPA target increased in those allocated to the FaME intervention
from 40% at baseline to 49% at 12 months post intervention. By contrast, the proportions remained at
38% in the usual-care arm and increased only marginally, from 41% to 43%, in those allocated to the
OEP arm. The benefit observed in the FaME arm at 12 months remained at 18 months.

Table 9 shows that the difference in attaining the exercise target 12 months post intervention, after
adjustment for dichotomised baseline activity, practice, practice deprivation, list size and site, was
statistically significant when comparing FaME patients with those allocated to usual care [odds ratio (OR)
1.78, 95% confidence interval (CI) 1.11 to 2.87; p=0.018]. There was no significant difference when
comparing OEP with usual-care patients (OR 1.17, 95% CI 0.72 to 1.92; p=0.52).

If 38% of patients in the usual-care arm would be meeting the target of 150 minutes of MVPA per week
at 12 months post intervention, an OR of 1.78 associated with FaME 12 months post intervention would
mean that 52% of participants would be meeting the guideline, an absolute increase of 14%.

To increase statistical power, we carried out analysis using the quantitative form of the primary outcome,
namely [loge(CHAMPS score+1)] at 12 months after the end of the intervention period. The positively
skewed nature of the distribution necessitated the use of logarithmic transformation. Figure 9 presents box
and whisker plots of minutes of MVPA by treatment arm and time, illustrating the distributions and
highlighting the occurrence of zero values in all treatment arms at 12 months post intervention; indeed,
there were 20% of participants reporting no activity at this time point.

Figure 10 shows the geometric mean number of minutes of MVPA per week, as measured by CHAMPS,
by time and group. This was obtained by calculating means of log-transformed CHAMPS scores, then
back transforming. Figure 10 shows this graphically, plotted on a logarithmic scale. Physical activity
increased in the FaME arm compared with usual care at 12 months after intervention ceased. The increase,
although slightly attenuated, still appears 18 months after intervention. Mean MVPA was higher in the
OEP arm at 12 months than for usual care, but a difference had already existed at baseline, prior
to randomisation.

Means of the loge(CHAMPS score+1)-transformed data were calculated and then back-transformed by
taking the exponential of the mean (for each group/time combination) and subtracting 1.

Formal analysis was carried out on the loge(CHAMPS score+1) values 12 months post intervention
(see Chapter 2); baseline level of loge(CHAMPS score+1), practice size, site and deprivation level were
covariates. A multilevel model was fitted, allowing for the clustering by general practice in the
study design.

Differences between each intervention arm and the usual-care arm are shown in Table 10, with 95% CIs.
The first column represents a complete case analysis (the primary analysis in our plan) and shows a
significant increase (p<0.001) in the mean log-transformed minutes of MVPA in the FaME arm of 0.689
(95% CI 0.312 to 1.065) compared with the control arm. This may be interpreted as a multiplicative effect
on minutes of MVPA by a factor of 1.99 (95% CI 1.37 to 2.90). The effect of OEP was positive (0.245,
95% CI –0.150 to 0.639) but non-significant (p=0.22), representing a multiplicative effect on minutes of
MVPA of 1.28 (95% CI 0.86 to 1.89).

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
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 THE PRIMARY OUTCOME AND SAFETY

TABLE 8 Proportion of participants achieving or exceeding MVPA target, by arm and time

Randomisation group

Percentage reaching 150 minutes MVPA, by group at each follow-up Usual care FaME OEP

Baseline

n 400 342 362

Number ≥150 minutes 150 136 150

Per cent ≥150 minutes 37.50% 39.77% 41.44%

Post intervention

n 264 224 224

Number ≥150 minutes 109 121 96

Per cent ≥150 minutes 41.29% 54.02% 42.86%

6 months post intervention

n 242 195 194

Number ≥150 minutes 107 79 85

Per cent ≥150 minutes 44.21% 40.51% 43.81%

12 months post intervention

n 222 193 185

Number ≥150 minutes 84 95 79

Per cent ≥150 minutes 37.84% 49.22% 42.70%

18 months post intervention

n 221 181 179

Number ≥150 minutes 81 89 78

Per cent ≥150 minutes 36.65% 49.17% 43.58%

100

80

Usual care
60
FaME
40 OEP

20

Baseline 0 6 12 18
Follow-up (months)

FIGURE 8 Proportion achieving or exceeding MVPA target, by arm over time.

36
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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

TABLE 9 Modelling of relative odds of reaching 150 minutes MVPA weekly, after adjustment for baseline MVPA

CHAMPS minutes of moderate or greater intensity activity (per week) (<150 minutes vs.
≥150 minutes)

Outcome Usual care FaME OEP

Number in model 210 184 178

Estimate (OR) N/A 1.782 1.173

95% CI N/A 1.106 to 2.872 0.718 to 1.918

p-value N/A 0.018 0.524

N/A, not applicable.

3000
Minutes

2000

1000

Usual care FaME OEP

Intervention arm

FIGURE 9 Box and whisker plot of minutes of MVPA 12 months post intervention by group, according to
CHAMPS questionnaire.

400
200
Minutes (log-scale)

100
50 Usual care
25 FaME

10 OEP

Baseline 0 6 12 18
Follow-up (months)

FIGURE 10 Geometric means of number of minutes of MVPA by group and time, according to
CHAMPS questionnaire.

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
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 THE PRIMARY OUTCOME AND SAFETY

TABLE 10 Results from multilevel modelling of 12-month post intervention primary outcomes
[loge(CHAMPS score+1)]

Imputed 12-month
post-intervention
CHAMPS, based on Imputed 12-month
Complete participants with post-intervention CHAMPS,
Model case analysis 12-month Phone-FITT based on all participants

Multilevel modelling results (group effects for FaME and OEP vs. usual care)a

Number in model 572 707 1254

FaME Estimate [difference 0.689 0.671 0.645

in mean loge
(CHAMPS score+1)]

95% CI 0.312 to 1.065 0.307 to 1.035 0.292 to 0.998

p-value <0.001 <0.001 <0.001

Multiplicative effect 1.99 1.96 1.91

on MVPA

95% CI 1.37 to 2.90 1.36 to 2.82 1.34 to 2.71

OEP Estimate 0.245 0.229 0.207

95% CI –0.150 to 0.639 –0.161 to 0.618 –0.152 to 0.566

p-value 0.22 0.25 0.26

Multiplicative effect 1.28 1.26 1.23

on MVPA

95% CI 0.86 to 1.89 0.85 to 1.86 0.86 to 1.76

a Uses loge(CHAMPS score+1) for baseline and 12-month post-intervention CHAMPS.
Fifty imputations used in each imputation model. All imputation models included:
Baseline CHAMPS, 12-month post-intervention CHAMPS, baseline Phone-FITT, 12-month post-intervention Phone-FITT.
Plus: site, group, practice size, practice deprivation (all fully observed).

Other columns of Table 10 show results after applying multiple imputation. The second column shows
results using only participants who had responded to the telephone-administered Phone-FITT questionnaire
and imputing the CHAMPS measure of MVPA using the Phone-FITT response. The multiplicative effect for
FaME on time in MVPA was barely altered at 1.96 (95% CI 1.36 to 2.82; p<0.001), whereas for OEP it
was 1.26 (95% CI 0.85 to 1.86; p=0.25). The last column shows a full imputation model using all
variables included in the substantive model. The benefit of FaME was still highly significant and of
comparable magnitude, now having a multiplicative effect on time in MVPA by 1.91 (95% CI 1.34 to
2.71; p<0.001), whereas for OEP it was 1.23 (95% CI 0.86 to 1.76; p=0.26).

Our primary analysis estimated a multiplicative effect on MVPA of 1.99. The median time in the usual-care
group at 12 months was 105 minutes, so this multiplicative effect would have added a further 104 minutes
(almost 15 minutes per day). The more conservative estimate after applying a fully imputed model would
suggest adding an extra 95 minutes per week (13–14 minutes per day).

Finally, Table 11 and Figure 11 show the percentage of participants who did no MVPA per week, as
measured by CHAMPS, by arm and over time. This was carried out as a post hoc analysis as it was
observed that many participants reported zero activity. The percentage of inactive participants changed
little in the usual-care arm, declined slightly in the OEP arm, but fell markedly in the FaME arm.

38
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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

TABLE 11 Percentage reporting 0 minutes MVPA, by group at each follow-up

Randomisation group

Measurement point Usual care FaME OEP

Baseline

n 400 342 362

Number=0 minutes 109 100 80

Per cent=0 minutes 27.25% 29.24% 22.10%

Post intervention

n 264 224 224

Number=0 minutes 64 46 40

Per cent=0 minutes 24.24% 20.54% 17.86%

6 months post intervention

n 242 195 194

Number=0 minutes 66 44 29

Per cent=0 minutes 27.27% 22.56% 14.95%

12 months post intervention

n 222 193 185

Number=0 minutes 54 30 36

Per cent=0 minutes 24.32% 15.54% 19.46%

Differences in denominators reflect variations in data capture and questionnaire completion.

100

80

60 Usual care
Minutes

FaME
40 OEP

20

0
Baseline 0 6 12 18
Follow-up (months)

FIGURE 11 Proportion of participants recording 0 minutes of MVPA per week, by arm over time.

To address the very slight difference in estimates of effectiveness of FaME compared with usual care
from the complete case analysis and imputation models, comparisons of baseline levels of CHAMPS and
Phone-FITT were made between participants included in the three models (see Appendix 2, Tables 38
and 39). Baseline levels of activity, as recorded by CHAMPS and Phone-FITT, were lower in those who did
not provide CHAMPS questionnaire data 12 months post intervention. The differences, however, were
comparable between participants allocated to the three arms of the trial. Hence, estimates of intervention
effects compared with usual care were almost unaffected.

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
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 THE PRIMARY OUTCOME AND SAFETY

Possible effect modifications of each intervention according to gender and to age group were tested
through fitting interactions; however, there was no evidence for effect modification in either case.

Sensitivity analyses

Analysis of the log(CHAMPS score+1) outcome was repeated (1) after excluding an outlying value for a
participant in the OEP arm (see Figure 10), (2) after excluding an individual whose reported number of falls
was extremely high post entry and (3) after excluding 18 participants who were considered ineligible by
GPs after randomisation had taken place. In all three analyses, the results concerning estimates of
intervention effects were essentially unaltered.

The ICCs for the primary outcome (CHAMPS minutes per week of moderate or greater intensity activity
at the 12-month post-intervention follow-up) were for the untransformed outcome 0.000 (95% CI 0.000
to 0.032) and the logarithmic transformation 0.009 (95% CI 0.000 to 0.044).

Adherence analysis

Different definitions were applied to participants in the FaME and OEP arms. In each case, analysis
comparing adherent and non-adherent participants was carried out. Comparisons of loge(CHAMPS
score+1) were made, with multilevel modelling as described above.

Falls Management Exercise programme

Expected activity consisted of two 30-minute sessions of home exercise, together with 60 minutes through
class attendance, per week for 24 weeks, totalling 2880 minutes. Defining adherence as 75% or more of
expected total exercise,31 meant that participants needed to carry out at least 2160 minutes of exercise
during the 24-week intervention to be classed as adherent. Two analyses were carried out: firstly assuming
that those not returning relevant diaries had not undertaken any exercise during that 4-week period and,
secondly, omitting any participant who had not returned all six diaries.

In the first analysis, 387 participants were eligible, of whom 60 (17%) were classed as adherent. In the
second analysis, 188 participants were eligible, of whom 58 (31%) were classed as adherent. However,
only a subset of eligible participants actually provided CHAMPS data 12 months post intervention, and
provision of outcome data was far less common among non-adherers (especially in the first analysis).
Among the subsets, there was no evidence of difference in primary outcome between adherers and
non-adherers for either analysis (p=0.67 and p=0.95, respectively). Appendix 2, Table 40, shows
the results.

Otago Exercise Programme

Expected activity consisted of three 30-minute sessions of home exercise per week for 24 weeks, totalling
2160 minutes. Defining adherence as 75% or more of expected total exercise meant that participants
needed to carry out at least 1620 minutes of exercise during the 24-week intervention to be classed
as adherent.

Three analyses were carried out: the first two were as specified for the analysis of FaME participants above
and the third compared participants who were assigned a PM with the remainder. Numbers of participants
eligible for the three analyses were 410 (among whom 25% were classed as adherent), 200 (46% classed
as adherent) and 366 (39% classed as adherent). As with the FaME analysis, only subsets of these
numbers provided CHAMPS data at 12 months, and provision of data was less common among
non-adherers, especially in the first analysis. No evidence of difference in outcome was apparent between
adherers and non-adherers in any analysis (p=0.54, p=0.42 and p=0.34, respectively, for the three
analyses). Appendix 2, Table 41, shows the results.

40
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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Safety: adverse events in the trial

There was only one documented SAE that the chief investigator thought could have been because of the
trial, and this was reported to the TSC’s chairperson. On further enquiry, this potential SAE was judged by
the TSC chairperson to be unrelated to the trial.

Table 12 summarises the categorisation process for harms arising in the participant population that could
potentially be attributed to the trial (see Chapter 3 for the categorisation algorithm).

Table 13 shows the numbers of events documented during the trial and Table 14 shows AEs,
reactions and incidents by arm, during the intervention period and in the 12 months post intervention,
per person-month.

Table 15 shows the clinical conditions categorised as AEs.

The number of falls recorded during the trial in diaries and followed up by telephone contact are shown in
Table 17 in Chapter 6. The different types of ARs are shown in Appendix 3.

TABLE 12 Categories of harm experienced by participants in the trial

First screen Serious Not serious

Subcategorisation Related SAE (report to TSC) Related AE

Possibly, probably or definitely related to the trial

Unrelated SAE Unrelated AE

Not related or improbably related to the trial

AR

Possibly, probably or definitely related to the trial

Possible AR

Possibly related to the trial

Incident

Non-injurious falls

TABLE 13 Numbers of all AEs and ARs occurring during ProAct65+ trial, by arm

AEs ARs Incident

Unrelated SAEs (% within (% within Possible ARs (% within
Allocation Total (% within category) category) category) (% within category) category)

FaME 770 8 (28%) 329 (30%) 14 (33%) 52 (31%) 338 (38%)

OEP 758 12 (41%) 378 (35%) 26 (62%) 59 (36%) 256 (29%)

Usual care 800 9 (31%) 386 (35%) 2 (5%) 55 (33%) 289 (33%)

Total 2328 29 1093 42 166 883

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
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 42
TABLE 14 Adverse events, reactions and incidents by arm, during the intervention period and in the 12 months post intervention, per person-month
THE PRIMARY OUTCOME AND SAFETY

NIHR Journals Library www.journalslibrary.nihr.ac.uk

Incidents AEs Possible ARs ARs Unrelated SAEs
Length of
Intervention observation/ Per Per Per Per Per
arm No. months Person-months No. person-month No. person-month No. person-month No. person-month No. person-month
During intervention

FaME 322 6 1932 141 0.073 74 0.038 11 0.006 12 0.006 5 0.0026

OEP 371 6 2226 74 0.033 91 0.041 23 0.010 16 0.007 5 0.0022

Usual care 396 6 2376 88 0.021 94 0.040 16 0.007 1 0.000 4 0.0017

After intervention

FaME 255 18 4590 120 0.026 181 0.039 35 0.008 1 0.0002 8 0.0017

OEP 290 18 5220 162 0.031 211 0.040 28 0.005 2 0.0004 15 0.0029
Usual care 303 18 5454 163 0.030 208 0.038 27 0.005 1 0.0002 16 0.0029
 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

TABLE 15 Adverse events by type

Medical problem Number in FaME Number in OEP Number in usual care

Cancer 15 28 18

Cardiovascular 23 51 49

Dermatological 9 12 16

Endocrine 9 13 9

Gastrointestinal 5 16 18
Gynaecological 2 1 2

Hospitalisation (cause unknown) 1 0 1

Musculoskeletal 28 36 27

Neurological 8 6 4

Ophthalmological 18 11 15

Orthopaedic/rheumatological 59 78 71

Renal 3 3 6
Respiratory 12 14 12

Urology 11 4 7

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Chapter 6 Secondary outcomes

Other physical activity measures

The CHAMPS questionnaire allowed calculation of weekly calories expended (Table 16). No significant
differences were observed whether the measure was analysed as its original value or after logarithmic
transformation. The full-time profiles are shown in Appendix 4 (Table 42 and Figure 12). Other
questionnaire batteries (PASE and Phone-FITT) measuring reported activity were also analysed. The
PASE scores showed a small, but statistically significant, benefit for FaME compared with usual care
(difference in means 11.2, 95% CI 0.2 to 20.2; p=0.046), but no statistically significant benefit for
OEP (difference in means 7.5, 95% CI –3.8 to 18.8; p=0.20). No significant differences were observed
according to Phone-FITT (reported through telephone interviews) [Table 17 and Appendix 4
(Table 42 and Figures 13 and 14)].

Falls and falls risk

The number of falls was analysed (1) during the intervention period and (2) in the 12 months following the
intervention (see Table 18). One very frequent faller (>100 falls reported during the intervention period)
was excluded from analysis, since his rate of falling should have excluded him from the trial, even though
his reported fall rate prior to baseline was within inclusion criteria. There was no statistically significant
difference in the number of falls among the FaME, OEP and the control arms during the intervention
period [adjusted incidence rate ratio (IRR) 0.91 (95% CI 0.54 to 1.52)] for FaME compared with usual care,
and IRR 0.93 (95% CI 0.64 to 1.37) for OEP compared with usual care. In the 12 months post intervention
there was a statistically significant reduction in falls in the FaME arm compared with the usual-care arm
(IRR 0.74, 95% CI 0.55 to 0.99; p=0.009) and a non-significant reduction in the OEP arm (IRR 0.76,
95% CI 0.53 to 1.09; p=0.14).

During the intervention period, participants in the FaME arm reported 39 falls with no injury, 31 falls with
a bruise or cut, 13 falls with muscle or ligament damage and one fall resulting in a broken bone. In the
OEP arm, participants reported 59 falls with no injury, 45 falls with a bruise or cut, 19 falls with muscle or
ligament damage, and two falls resulting in a broken bone. In the usual-care arm, participants reported
34 falls with no injury, 59 falls with a bruise or cut, 23 falls with muscle or ligament damag, and six falls
resulting in a broken bone.

The FES-I index, which measures participants’ fear of falling, showed no significant differences according
to intervention arm (Table 18 and Appendix 4).

Quality-of-life measures

No significant differences were apparent at 12 months for either component of the SF-12 (mental or
physical), the EQ-5D scores or the OPQoL (Tables 19 and 20). Details of profiles over time are shown in
Appendix 4 (Table 44 and Figure 16).

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 SECONDARY OUTCOMES

TABLE 16 Analysis of total weekly calorific expenditure by intervention arm at baseline and 12 months
post intervention

Log-CHAMPS total calorific expenditure

CHAMPS total calorific expenditure (per week) (per week)

Outcome Usual care FaME OEP Usual care FaME OEP

Baseline Baseline
Mean (SD) 2222.3 2129.1 2314.0 6.982 (1.931) 6.914 (2.013) 7.227 (1.516)
(2180.9) (2009.5) (2009.8)

Median 1713.6 1690.6 1782.2 7.447 7.433 7.486

(min., max.) (0.0, 22967.8) (0.0, 14793.2) (0.0, 13272.7) (0.000, 10.042) (0.000, 9.602) (0.000, 9.494)

n 391 339 354 391 339 354

12 months post intervention 12 months post intervention

Mean (SD) 2573.6 2660.9 2787.5 7.314 (1.576) 7.382 (1.568) 7.530 (1.141)
(2158.8) (2248.0) (2771.6)

Median 1829.4 2079.8 2004.1 7.512 7.640 7.603

(min., max.) (0.0, 9876.2) (0.0, 15,272.9) (0.0, 24,288.5) (0.000, 9.198) (0.000, 9.634) (0.000, 10.098)

n 221 192 184 221 192 184

Number 569 569

in model

Estimate N/A 217.7 42.1 N/A 0.084 0.216

95% CI N/A –184.1 to –380.3 to N/A –0.195 to –0.078 to

619.6 464.5 0.364 0.511
p-value N/A 0.288 0.845 N/A 0.555 0.150
max., maximum; min., minimum; N/A, not applicable.
Differences in denominators reflect variations in data capture and questionnaire completion.

TABLE 17 Comparisons of reported falls between intervention arms

Reported falls FaME OEP Usual care

No. of falls during intervention period 96 104 116

Person-years at risk during intervention period 117.9 129.8 133.9

Falls per person-year during intervention period 0.81 0.80 0.87

IRR (95% CI) during intervention period (compared with 0.91 (0.54 to 0.93 (0.64 to Ref
usual care)a 1.522; p=0.72) 1.37; p=0.72)

No. of falls in the 12 months post intervention 107 100 158

Person-years at risk in the 12 months post intervention 187.3 184.0 221.3

Falls per person-year in the 12 months post intervention 0.57 0.54 0.71
IRR (95% CI) in the 12 months post intervention 0.74 (0.55 to 0.76 (0.53 to Ref
(compared with usual care)a 0.99; p=0.042) 1.09; p=0.14)
Ref, reference.
a IRRs from model adjusting for effects of site, size of practice, deprivation of practice, and clustering due to practice.

46
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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

TABLE 18 Distribution of FES-I scores by time and intervention arm

FES-I

Outcome Usual care FaME OEP

Baseline

Mean (SD) 9.36 (4.08) 8.99 (3.56) 8.89 (3.49)

Median (min., max.) 8 (7, 28) 7 (7, 28) 7 (7, 28)

n 396 333 359

12 months post intervention

Mean (SD) 8.94 (3.66) 9.20 (4.56) 9.09 (4.19)

Median (min., max.) 7 (7, 28) 7 (7, 28) 7 (7, 28)

n 220 188 185

Number in model 561

Estimate N/A 0.102 0.045

95% CI N/A –0.653 to 0.856 –0.740 to 0.831

p-value N/A 0.792 0.910

max., maximum; min., minimum; N/A, not applicable.
Differences in denominators reflect variations in data capture and questionnaire completion.

TABLE 19 Distribution of SF-12 physical and mental component scores by time and intervention arm

SF-12 PCS SF-12 MCS

Outcome Usual care FaME OEP Usual care FaME OEP

Baseline Baseline
Mean (SD) 38.74 (5.50) 38.74 (5.64) 38.78 (5.64) 49.88 (6.09) 49.60 (6.02) 50.15 (5.86)

Median 39.23 38.86 38.86 50.59 50.36 50.46

(min., max) (15.98, 55.12) (20.02, 55.17) (16.90, 55.20) (9.54, 70.19) (27.10, 67.49) (28.21, 66.46)

n 454 386 407 454 387 407

12 months post intervention 12 months post intervention

Mean (SD) 39.11 (5.00) 38.85 (4.92) 39.30 (4.73) 49.16 (5.60) 48.74 (5.81) 49.05 (5.11)

Median 38.86 38.87 39.30 49.86 48.98 49.05

(min., max.) (20.71, 53.56) (25.52, 55.66) (21.05, 51.90) (31.52, 66.56) (29.59, 63.57) (29.90, 64.18)

n 217 186 183 217 186 183

Number 583 584

in model
Estimate N/A –0.211 0.278 N/A –0.430 –0.172

95% CI N/A –1.125 to –0.672 to N/A –1.506 to –1.291 to

0.703 1.229 0.646 0.947

p-value N/A 0.651 0.566 N/A 0.434 0.763

max., maximum; MCS, mental component score; min., minimum; N/A, not applicable; PCS, physical component score.
Differences in denominators reflect variations in data capture and questionnaire completion.

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
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 SECONDARY OUTCOMES

TABLE 20 Distribution of OPQoL and EQ-5D scores by time and intervention arm

Outcome OPQoL total score EQ-5D score

Descriptive statistics
Usual care FaME OEP Usual care FaME OEP
Baseline Baseline
Mean (SD) 130.75 (13.53) 129.36 (13.54) 129.36 (12.69) 0.675 (0.082) 0.672 (0.087) 0.675 (0.088)
Median 129.00 129.00 128.00 0.688 0.688 0.688
(min., max.) (93.00, 163.00) (96.00, 163.00) (97.00, 162.00) (0.260, 0.855) (0.388, 0.905) (0.253, 0.922)
n 342 273 312 450 380 399
12 months post intervention Post intervention
Mean (SD) 134.80 (14.82) 132.31 (15.98) 133.72 (14.95) 0.675 (0.072) 0.667 (0.072) 0.675 (0.074)
Median 135.00 132.00 134.00 0.683 0.675 0.688
(min., max.) (91.00, 165.00) (93.00, 163.00) (95.00, 164.00) (0.358, 0.885) (0.381, 0.846) (0.285, 0.841)
n 185 169 156 212 179 176
Multilevel modelling results (group effects vs. usual care)
Number 444 558
in model
Estimate N/A –0.794 0.374 N/A –0.009 0.000
95% CI N/A –2.848 to 1.260 –1.772 to 2.520 N/A –0.022 to –0.014 to
0.005 0.015
p-value N/A 0.449 0.733 N/A 0.229 0.958
max., maximum; min., minimum; N/A, not applicable.
Differences in denominators reflect variations in data capture and questionnaire completion.

Balance confidence and social networks

Table 21 shows differences between arms on balance confidence and social network support. Significant
improvements in balance confidence were seen in both intervention arms at 12 months post intervention.
The mean difference for FaME compared with usual care was –0.529 (95% CI –0.998 to –0.061;
p=0.027) while the mean difference for OEP compared with usual care was –0.545 (95% CI –1.033 to
–0.057; p=0.029). No significant difference in either social network scale (MSPSS or LSNS) was observed
when comparing FaME and OEP to the usual-care arm. Further information concerning changes over time
is shown in Appendix 4 (Table 45 and Figure 17).

Other secondary outcomes (measures taken only at baseline

and immediately post intervention)

Table 22 shows no evidence for effect of either intervention on the FRAT. However, clear benefits were seen
on the OEE scale (Table 22). Those in the FaME arm whose expectations of exercise were positive at baseline
had significantly increased expectations of exercise at follow-up compared with those in the usual-care
arm. Those who were negative about exercise at baseline improved their expectations at follow-up, in both
FaME and OEP arms, compared with usual care. Changes from baseline to post intervention are shown in
Appendix 4 (Table 46). Results are shown for three functional measures in Table 23. No significant effects of
intervention were observed. Table 24 shows outcomes for PASE, Phone-FITT and the mental and physical
components of the SF-12 scale. Table 25 shows results for quality of life (OPQoL) and falls risk assessment
(FRAT score). Table 26 shows results for the FRAT binary score (0 or ≥1). Table 27 shows the results from
multilevel modelling of post intervention and 6- and 12-month post-intervention scores on EQ-5D.

48
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SO16 7NS, UK.
TABLE 21 Differences in balance confidence and social networks, by arm, over time

Outcome ConfBal MSPSS LSNS

DOI: 10.3310/hta18490

Descriptive statistics

Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP
Baseline Baseline Baseline

Mean (SD) 12.55 (3.93) 12.63 (3.98) 12.48 (3.76) 65.81(17.96) 65.93 (15.57) 66.60 (15.49) 15.93 (5.70) 16.47 (5.76) 15.44 (5.48)

Median 11 (10, 29) 10 (10, 30) 11 (10, 30) 71 (12, 84) 69 (12, 84) 70.5 (12.0, 84.0) 16 (0, 30) 17 (3, 30) 15 (1, 30)
(min., max.)

n 389 330 353 375 305 330 392 330 351

12 months post intervention 12 months post intervention 12 months post intervention

Mean (SD) 12.38 (4.05) 12.13 (3.65) 12.23 (3.71) 67.23 (16.54) 63.27 (17.69) 63.46 (18.14) 16.41 (5.79) 15.68 (5.82) 15.43 (5.35)

Median 10 (10, 30) 10 (10, 28) 10 (10, 28) 71 (12, 84) 67 (12, 84) 68 (12, 84) 17 (4, 30) 16 (0, 30) 16 (1, 30)
(min., max.)

n 218 183 179 209 183 171 210 181 180

Multilevel modelling results (group effects vs. usual care)

Number 546 500 533

in model

Estimate N/A –0.529 –0.545 N/A −2.480 −2.373 N/A −0.651 0.176

95% CI N/A −0.998 to −0.061 −1.033 to −0.057 N/A −5.637 to 0.677 −5.700 to 0.953 N/A −1.411 to 0.110 −0.624 to 0.976

p-value N/A 0.027 0.029 N/A 0.124 0.162 N/A 0.093 0.666
max., maximum; min., minimum; N/A, not applicable.
Differences in denominators reflect variations in data capture and questionnaire completion.

Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton
suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR
HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
49
 50
TABLE 22 FRAT scores and OEE scores by arm, over time
SECONDARY OUTCOMES

Outcome FRAT score OEE positive OEE negative

Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP

Baseline Baseline Baseline

Mean (SD) 1.029 (0.955) 0.890 (0.900) 0.980 (0.899) 3.84 (0.58) 3.85 (0.62) 3.85 (0.60) 3.85 (0.81) 3.96 (0.75) 3.90 (0.85)

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Median 1 (0, 4) 1 (0, 4) 1 (0, 4) 3.89 (2.00, 5.00) 3.89 (1.67, 5.00) 3.78 (1.67, 5.00) 4 (1.25, 5.00) 4 (1.75, 5.00) 4 (1, 5)
(min., max.)

n 453 383 402 372 309 349 367 320 339

12 months post intervention Post intervention Post intervention

Mean (SD) 0.987 (0.905) 0.929 (0.944) 0.996 (0.951) 3.85 (0.64) 4.02 (0.55) 3.93 (0.65) 3.96 (0.87) 4.19 (0.75) 4.20 (0.71)

Median 1 (0, 4) 1 (0, 4) 1 (0, 4) 3.78 (2.11, 5.00) 4.00 (2.33, 5.00) 3.89 (1.00, 5.00) 4 (1, 5) 4.25 (1.00, 5.00) 4 (1, 5)
(min., max.)

n 299 253 263 252 206 211 248 204 203

Number 808 614 595

in model

Estimate N/A −0.004 0.030 N/A 0.130 0.083 N/A 0.200 0.252

95% CI N/A −0.160 to 0.152 −0.127 to 0.189 N/A 0.043 to 0.216 −0.006 to 0.171 N/A 0.077 to 0.323 0.125 to 0.379

p-value N/A 0.960 0.708 N/A 0.003 0.066 N/A 0.001 <0.001
max., maximum; min., minimum; N/A, not applicable.
Differences in denominators reflect variations in data capture and questionnaire completion.
SO16 7NS, UK.
TABLE 23 Functional assessment scores, by arm, over time

Outcome Sits to stands (total) Functional reach Log-TUG (seconds)

DOI: 10.3310/hta18490

Descriptive statistics

Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP
Baseline Baseline Baseline

Mean (SD) 10.49 (3.31) 10.48 (3.64) 10.27 (2.81) 24.68 (7.43) 25.60 (6.98) 25.57 (7.43) 2.35 (0.32) 2.33 (0.34) 2.33 (0.34)

Median 10 (0, 26) 10 (1, 28) 10 (3, 20) 25 (4, 49) 26 (8, 45) 26 (4, 55) 2.29 (1.74, 3.70) 2.26 (1.41, 4.02) 2.29 (1.71, 4.58)
(min., max.)
n 449 377 400 438 371 402 438 337 376

Post intervention Post intervention Post intervention

Mean (SD) 11.86 (3.57) 11.62 (3.77) 11.40 (3.35) 27.13 (6.82) 26.99 (7.28) 26.84 (7.64) 2.28 (0.27) 2.25 (0.30) 2.27 (0.27)

Median 12 (2, 25) 11 (3, 29) 11 (0, 22) 28 (10, 45) 27 (7, 46) 27 (7, 44) 2.23 (1.79, 4.05) 2.20 (1.48, 3.60) 2.23 (1.69, 3.81)
(min., max.)

n 285 252 245 293 249 232 273 203 203

Multilevel modelling results (group effects vs. usual care)

Number 772 749 651

in model

Estimate N/A −0.644 −1.055 N/A −0.644 −1.055 N/A −0.008 −0.011

95% CI N/A −2.583 to 1.295 −3.031 to 0.921 N/A −2.583 to 1.295 −3.031 to 0.921 N/A −0.064 to 0.048 −0.066 to 0.044

p-value N/A 0.515 0.295 N/A 0.515 0.295 N/A 0.775 0.700
max., maximum; min., minimum; N/A, not applicable.
Differences in denominators reflect variations in data capture and questionnaire completion.

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HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
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51
 52
TABLE 24 Outcomes for PASE, Phone-FITT and the mental and physical components of the SF-12 scale

Outcome PASE total score Phone-FITT total score SF-12 PCS SF-12 MCS

Descriptive statistics
Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP
SECONDARY OUTCOMES

Baseline Baseline Baseline Baseline

Mean (SD) 119.2 109.1 119.9 36.80 37.68 41.18 38.74 38.74 38.78 49.88 49.60 50.15
(60.4) (52.2) (50.6) (13.65) (13.67) (13.11) (5.50) (5.64) (5.64) (6.09) (6.02) (5.86)

Median 111.1 107.1 116.8 36.0 37.46 40.67 39.23 38.86 38.86 50.59 50.36 50.46

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(min., max.) (0.0, 379.5) (0.0, 356.6) (8.57, (0.00, 85.83) (0.0, 102.0) (7.00, (15.98, (20.02, (16.90, (9.54, (27.10, (28.21,
280.60) 80.83) 55.12) 55.17) 55.20) 70.19) 67.49) 66.46)

n 400 342 362 377 316 354 454 386 407 454 387 407
12 months post intervention 12 months post intervention 12 months post intervention 12 months post intervention

Mean (SD) 122.5 124.2 126.8 47.71 49.52 49.38 39.11 38.85 39.30 49.16 48.74 49.05
(51.8) (53.3) (61.3) (17.41) (15.95) (16.50) (5.00) (4.92) (4.73) (5.60) (5.81) (5.11)

Median 118.1 116.0 114.6 47.75 47.63 50.33 38.86 38.87 39.30 49.86 48.98 49.05
(min., max.) (0.0, 277.7) (0.0, 269.7) (0.0, 356.6) (0.0, 162.33) (8.0, 112.5) (0.00, (20.71, (25.52, (21.05, (31.52, (29.59, (29.90,
97.75) 53.56) 55.66) 51.9) 66.56) 63.57) 64.18)

n 222 193 185 225 208 237 217 186 183 217 186 183

Multilevel modelling results (group effects vs. usual care)

Number 572 628 583 584

in model

Estimate N/A 11.19 7.48 N/A 2.303 1.340 N/A −0.211 0.278 N/A −0.430 −0.172

95% CI N/A 0.194 to −3.826 to N/A −0.531 to −1.494 to N/A −1.125 to −0.672 to N/A −1.506 to −1.291 to
22.191 18.794 5.137 4.174 0.703 1.229 0.646 0.947

p-value N/A 0.046 0.195 N/A 0.111 0.354 N/A 0.651 0.566 N/A 0.434 0.763
max., maximum; MCS, mental component score; min., minimum; N/A, not applicable; PCS, physical component score.
Differences in denominators reflect variations in data capture and questionnaire completion.
 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

TABLE 25 Total OPQoL and FRAT scores, by arm

Outcome OPQoL total score FRAT score

Descriptive statistics

Usual care FaME OEP Usual care FaME OEP

Baseline Baseline

Mean (SD) 130.75 (13.53) 129.36 (13.54) 129.36 (12.69) 1.029 (0.955) 0.890 (0.900) 0.980 (0.899)

Median 129.00 129.00 128.00 1 (0, 4) 1 (0, 4) 1 (0, 4)

(min., max.) (93.00,163.00) (96.00, 163.00) (97.00, 162.00)

n 342 273 312 453 383 402

12 months post intervention Post intervention

Mean (SD) 134.80 (14.82) 132.31 (15.98) 133.72 (14.95) 0.987 (0.905) 0.929 (0.944) 0.996 (0.951)

Median 135.00 132.00 134.00 1 (0, 4) 1 (0, 4) 1 (0, 4)

(min., max.) (91.00, 165.00) (93.00, 163.00) (95.00, 164.00)

n 185 169 156 299 253 263

Multilevel modelling results (group effects vs. usual care)

Number 444 808

in model

Estimate N/A −0.794 0.374 N/A −0.004 0.030

95% CI N/A −2.848 to −1.772 to N/A −0.160 to −0.127 to

1.260 2.520 0.152 0.189

p-value N/A 0.449 0.733 N/A 0.960 0.708

max., maximum; min., minimum; N/A, not applicable.
Differences in denominators reflect variations in data capture and questionnaire completion.

TABLE 26 Changes in dichotomised FRAT scores, by arm

Outcome FRAT binary (score ≥1)

Usual care FaME OEP

Baseline

Percentage with score ≥1 65.8% 60.6% 65.6%

n 453 383 402

Post intervention

Percentage with score ≥1 65.5% 62.1% 64.6%

n 299 253 263

Number in model 808

Estimate (OR) N/A 0.857 1.000

95% CI N/A 0.504 to 1.460 0.584 to 1.716

p-value N/A 0.571 0.998

N/A, not applicable.
Differences in denominators reflect variations in data capture and questionnaire completion.

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR
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 54
SECONDARY OUTCOMES

TABLE 27 European Quality of Life-5 Dimensions: descriptive statistics by group at baseline, post intervention and 6 and 12 months post intervention

Usual Usual Usual Usual

care FaME OEP care FaME OEP care FaME OEP care FaME OEP
Descriptive
Statistics Baseline Post intervention 6 months post intervention 12 months post intervention

NIHR Journals Library www.journalslibrary.nihr.ac.uk

Mean (SD) 0.675 0.672 0.675 0.700 0.691 0.705 0.661 0.668 0.674 0.675 0.667 0.675
(0.082) (0.087) (0.088) (0.074) (0.083) (0.071) (0.080) (0.085) (0.070) (0.072) (0.072) (0.074)

Median 0.688 0.688 0.688 0.704 0.702 0.706 0.671 0.685 0.685 0.683 0.675 0.688
(min., max.) (0.260, (0.388, (0.253, (0.400, (0.261, (0.311, (0.271, (0.351, (0.411, (0.358, (0.381, (0.285,
0.855) 0.905) 0.922) 0.870) 0.870) 0.942) 0.809) 0.845) 0.804) 0.885) 0.846) 0.841)

n 450 380 399 296 255 258 225 178 184 212 179 176

Multilevel modelling results (group effects vs. usual care)

Number N/A 793 576 558

in model

Estimate N/A N/A N/A N/A −0.007 0.008 N/A 0.008 0.018 N/A −0.009 0.000

95% CI N/A N/A N/A N/A −0.019 to −0.005 to N/A −0.007 to 0.003 to N/A −0.022 to −0.014 to
0.006 0.020 0.023 0.033 0.005 0.015

p-value N/A N/A N/A N/A 0.301 0.238 N/A 0.301 0.021 N/A 0.229 0.958
max., maximum; min., minimum; N/A, not applicable.
Differences in denominators reflect variations in data capture and questionnaire completion.
 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Chapter 7 Economic analysis

Intervention costs – NHS perspective

Otago Exercise Programme

The OEP intervention involved a 30-minute programme of leg muscle strengthening and balance retraining
performed at home at least three times per week and a walking plan undertaken at least twice per week,
for 24 weeks. Participants attended an induction event, in groups, at a local community centre, which
included individual assessment and setting of an exercise regimen. Ankle weights were distributed and an
instruction booklet provided.

A PM was assigned to make contact with each participant. PMs received basic training in mentoring skills
and were asked to make a home visit to help their mentee start their exercise programme, and up to three
more home visits during the course of the 6-month intervention. In addition, the intervention protocol
recommended that PMs maintain contact with and provide encouragement and support to their mentee
through telephone calls every 2 weeks. PMs kept logs of their contacts with each of their mentees
(date, time, duration and method of contact).

Otago Exercise Programme resources

Problems were encountered in recruiting PMs (see Chapter 2), especially in Nottingham, and some
participants could not be allocated a PM. Thirty-six PMs were used in London, supporting 122 of
230 participants (53.0%) in OEP practices (mean 3.3, median 2.0 participants per PM). In Nottingham,
only seven PMs were hired, supporting 21 of 168 (12.5%) OEP participants (mean 3.0, median 3.0
participants per PM).

Otago Exercise Programme costs

Cost items associated with use of PM were calculated as a cost per participant with a PM. Other costs,
such as hall hire for the induction sessions that were attended by all OEP participants, were calculated with
total OEP participants as the denominator (see Table 28 for OEP costs). The costs per OEP participant with
a PM were £88.16 in London and £117.08 in Nottingham. The per-participant costs of ankle weights were
higher in London as greater access to PMs meant that more participants graduated to receive additional
(highest-weight) cuffs. PM training costs were higher in Nottingham because of the smaller number of PMs
attending sessions.

Falls Management Exercise programme resources

The FaME intervention comprised a 1-hour group exercise class with PSIs and two 30-minute home
exercise sessions per week, for 24 weeks, plus walking twice per week for 30 minutes. Nine or ten
participants were allocated to each group, with multiple classes per week for each GP practice. Seventeen
groups were run in London by seven PSIs for 162 participants (mean 9.5 per group). There were five PSIs
in Nottingham running 20 groups for 194 participants (9.7 per group). PSIs monitored attendance on a
weekly basis. The aim was to provide continuity of PSI for each group, although occasionally PSIs would
cover for each other for sickness or holidays.

The delivery of the intervention was standardised through training of PSIs and quality assurance visits.
Participants are given elastic resistance bands and an instruction booklet for the home exercise component.
Exercise mats were purchased for use in the group sessions.

Falls Management Exercise programme costs

The per-participant costs averaged £268.74 in London and £218.43 in Nottingham; PSI reimbursement
was the largest cost component, followed by hire of the venues. The higher cost of FaME venues in

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
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 ECONOMIC ANALYSIS

TABLE 28 Otago Exercise Programme costs

OEP intervention costs

London (N=230); 122 (53.0%) with PM Nottingham (N=168); 21 (12.5%) with PM

Per participant with Per participant with

Category Total PM (n=122) Total PM (n=21)

PM traininga £2771.70 (36 PMs, £22.72 £973.60 (7 PMs, £46.36

£76.99 per PM) £139.09 per PM)

PM expenses £608.40 £4.99 £243.76 £11.61

reimbursementb

Imputed value of PM 84 visits, 4178 0.69 visits per 21 visits, 893 minutes 1 visit per participant,
time, for visits and minutes (mean 49.7 participant £16.54 (mean 42.5 minutes, £20.54
telephone calls minutes, SD 25.6 SD 15.0 minutes)=
to participantsc minutes) =£2017.97 0.62 telephone calls £431.32 (£20.54/visit) 0.81 telephone calls
(£24.02/visit) per participant £2.14 per participant, £2.63
17 telephone calls,
75 telephone calls, Both: £18.68 138 minutes (mean Both: £23.17
652 minutes (mean 8.1 minutes, SD 2.6
8.7 minutes, SD 4.7 minutes)=£55.20
minutes)=£260.80 (£3.25/telephone call)
(£3.48/telephone call)

Per all participants Per all participants

(n=230) (n=168)

Induction – hall hired £1484.00 (31 groups, £6.45 (mean group £861.44 (18 groups, £5.13 (mean group
£47.87 per group; size 7.6) £47.86 per group; size 9.3)
range £28–90) range £18–90)
Induction – £3491.00 £15.18 £2550.00 £15.18
trainer timee
Induction – £92.00 £0.40 £67.20 £0.40
refreshmentsf

Ankle cuffsg £3918.29 £17.04 £2104.56 £12.53

Instruction bookleth £621.00 £2.70 £453.60 £2.70

Total £15,265.16 £7740.68

Per participant, £41.77 £35.94

no PM

Per participant, £88.16 £117.08

with PM
a From study records, includes reimbursement to expert trainers of PMs, excludes facilities costs.
b From study records, includes travel for home visits (free for most PMs in London) and telephone calls.
c Based on clinical support worker:74 £29 per hour of home visit, 48.3p per minute; for telephone calls, £24 per hour of
patient-related activity, 40p per minute.
d From study records.
e Expert trainers used in Nottingham at £220 per session. Salaried project staff provided training in London, so the
Nottingham per-participant rate applied pro rata to London.
f From study records – only provided in Nottingham, assume same for London.
g From study records, includes cuffs given to all at induction and additional cuffs given to participants who progressed.
h From study records. Folder 70p, printing of 40 pages at 5p per page, total £2.70 per participant.

56
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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

London reflects differences in rents between the capital and Nottingham, although there was considerable
variation within both sites. Participants were recruited by general practice (cluster randomised) and the
main criterion for selecting halls was proximity. Table 29 shows FaME costs.

Comparing OEP and FaME

The FaME programme is more expensive than the OEP delivered with PMs (£269 vs. £88 per participant in
London; £218 vs. £117 in Nottingham) as a result of more direct participant contact from PSIs and hire of
halls for the exercise classes. The difference between groups in per-participant costs would have been
smaller if the OEP had been delivered to protocol (the full quota of home visits and telephone calls) and
this might have had an impact on effectiveness. The costs of equipment were higher in the OEP (ankle
cuffs) than in the FaME programme (resistance bands and mats); the home exercise booklet was also more
extensive and costly than that provided to FaME programme participants, but these items represented
small proportions of the total costs.

Discussion

The reasons for the low PM contact with mentees in the OEP arm are not fully known. The lower PM
input, or lack of PM input for a significant proportion of participants, may have impacted effectiveness to
an unknown extent.

Although PMs were volunteers, a cost was applied to PM time, inputted using a replacement cost method
(based on a clinical support worker). Use of the opportunity cost method would have required further
information from PMs about the activities that they were not doing in order to carry out PM

TABLE 29 Falls Management Exercise programme costs

FaME intervention costs

London (n=162) Nottingham (n=194)

Per participant Per participant

(cost of item as (cost of item as
Category Total % of total) Total % of total)

PSI reimbursementa £27,744.00 (17 groups) £171.26 (63.7%) £32,640.00 (20 groups) £168.25 (77.0%)

PSI trainingb £1550.00 7 PSIs £9.63 (3.6%) £1405.00 5 PSIs £7.24 (3.3%)
(£214.28 per PSI) (£281.00 per PSI)

Hall hirec £12,982.00 £80.63 (30.0%) £6929.50 £35.72 (16.3%)

(£763.65 per group; (£346.28 per group;
range £540–938) range £221–417)

Refreshmentsd £196.42 £1.22 (0.5%) £237.08 £1.22 (0.6%)

e
Mats £563.50 £3.50 (1.3%) £679.00 £3.50 (1.6%)
f
TheraBands £322.00 £2.00 (0.7%) £388.00 £2.00 (0.9%)

Instruction bookletg £80.50 £0.50 (0.2%) £97.00 £0.50 (0.2%)

Total £43,438.42 £268.74 £42,375.58 £218.43

74
a Based on community physiotherapist : £34 per hour, 2 hours allowed, to include preparation, clear-up and travel time.
Twenty-four classes per group=£1632×17 groups=£27,744 London; £1632× 20 groups=£32,640 Nottingham.
b From study records, only includes top-up training. Unit cost of community physiotherapists includes qualifications.
Facilities cost of top-up training excluded.
c From study records.
d From study records in Nottingham; no data in London, so Nottingham rates applied.
e From study records. Mats were priced at £10.50 each, approximately one mat purchased for every three participants.
f From study records. TheraBands at £6; each TheraBand divided between three participants.
g From study records. Booklet 10 pages, 0.5p per page=£0.50.

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR
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 ECONOMIC ANALYSIS

responsibilities. If PMs were retired, the opportunity cost of their time may have been less than the
replacement cost used and the per-participant cost in the OEP arm would have been lower. Moreover, if
volunteer PMs had obtained positive utility from their contribution, their cost should have been reduced
accordingly.75 Problems with recruiting PMs might have been mitigated if they had been remunerated and
this may have also resulted in more active support of mentees.

Per-participant costs in delivery of the FaME programme would be inversely affected by group size, but
group size might also affect effectiveness to an unknown extent. In the trial, the mean group size was
similar in both sites at allocation (9 or 10 participants, as planned per protocol). However, poor attendance
at some groups [mean group attendance rates were 50.5% (range 35–68%) in London and 56.9%
(range 28–68%) in Nottingham] indicates that actual costs per attendee were higher and that a larger
group size at the outset may be possible so that there is still a core group of active participants after
drop-out. Attendance rates of participants assigned to the FaME programme ranged from 0% to 100% in
both sites.

Intervention costs – private/participant perspective

Out-of-pocket expenditures
Data on exercise-related out-of-pocket expenditure (clothes, equipment, gym membership, etc.) were
analysed for the 592 participants (of 603 recruited) in London and the 594 (of 651) in Nottingham. The
remaining 11 and 57 volunteers, respectively, were excluded by their GPs on health grounds (considered
too unfit to take part in the interventions). Information on private expenditures was captured through diary
returns (six during the intervention period and four in the subsequent 12-month follow-up period). Over
60% of diaries were returned during the intervention, although response rates varied between groups and
were lowest in London. Diary returns dropped in London in the follow-up period to below 50% and in the
OEP group in Nottingham.

Relatively small numbers of participants reported out-of-pocket expenditures and the average per-participant
spend both during the 6-month intervention and in the 12-month follow-up period was <£10, but variable
across groups and sites in a non-systematic way (Table 30 shows out-of-pocket expenditures).

Additional expenditure was incurred by participants in the FaME group for travel to exercise classes.
Participants were asked to report their usual method of getting to the class at the 6-month
(end-of-intervention) assessment point. Responses were received by just over half of participants and
showed that the average round-trip distance travelled for classes was 1.5 miles in London and 3.1 miles in
Nottingham, reflecting the relative population densities of the areas. Accordingly, higher proportions of
participants reported walking to classes, and lower proportions using cars, in London than in Nottingham
(FaME travel costs are shown in Table 31).

Almost all participants who used public transport reported that they had a free bus pass, so participants
incurring out-of-pocket costs associated with travel to classes were mostly those using private cars (28% in
London and 74% in Nottingham). The maximum average cost incurred in driving to classes in London
(assuming 45p per mile, the NHS reimbursement rate for staff) was £16.20 for the 24 classes and in
Nottingham was £33.48 because of the longer round-trip distance to the venue. Only one individual
reported parking charges (of £4.00 per class).

Productivity effects
Participants in the FaME programme were also asked to report at the post-intervention assessment what
activity they had given up to attend the exercise classes. This question was answered by <30% of people
assigned to the FaME group. The largest proportion of responders stated that they had given up
recreational activities, followed by home making. Only two people stated they had given up paid
employment, both in Nottingham. A total of 14 (13%) reported giving up voluntary or caring
responsibilities (FaME programme opportunity costs are shown in Table 32).

58
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 TABLE 30 Out-of-pocket expenditures

SO16 7NS, UK.

Number of Number of Number of items purchased
Number diaries participants Spend per
Number after GP returned/total % of possible reporting Total participant
Site Group recruited exclusion possible diaries returned an expenditure All S C EE & G O expenditure after GP exclusions
During the 6-month intervention period: diaries 1–6
DOI: 10.3310/hta18490

London OEP 168 230 841/1340 60.9 32 49 20 20 1 8 £1398.40 £6.08

FaME 232 162 601/972 61.8 19 28 8 7 2 11 £799.47 £4.93

Usual 203 200 649/1200 54.1 26 42 10 5 19 7 £1704.96 £8.52

care

Total 603 592 2091/3512 59.5 77 119 38 32 22 26 £3902.83 £6.59

Nottingham OEP 179 168 728/1008 72.2 48 64 17 29 1 17 £1352.78 £8.05

FaME 219 194 838/1164 72.0 18 23 8 8 0 7 £496.58 £2.56

Usual 253 232 958/1392 68.8 34 56 9 18 8 21 £1704.65 £7.34

care

Total 651 594 2524/3554 71.0 100 152 42 66 2 42 £3553.01 £5.98

During the 12-month post intervention follow-up period: diaries 7–10

London OEP 168 230 399/920 43.4 21 21 10 10 1 0 £632.72 £2.75

FaME 232 162 299/648 46.1 26 26 5 9 6 6 £1512.98 £9.34

Usual 203 200 330/800 41.2 32 31 6 14 7 4 £1121.35 £5.61
care

Total 603 592 1028/2364 43.5 79 78 21 33 14 10 £3267.05 £5.52

Nottingham OEP 179 168 345/672 51.3 16 16 2 6 1 7 £769.49 £5.48

FaME 219 194 565/776 72.8 31 31 9 14 2 6 £719.30 £3.70

Usual 253 232 672/928 72.4 38 38 12 12 7 7 £2453.63 £10.58

care

Total 651 594 1582/2376 66.6 85 85 23 32 10 20 £3942.42 £6.64

C, clothes; EE & G, exercise equipment and gym membership; O, other; S, shoes.

Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton
suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR
HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
59
 ECONOMIC ANALYSIS

TABLE 31 Falls Management Exercise programme travel costs

Usual method of travel to class

Number (%) of participants using

Number (%) Average round-
Number of providing trip distance to Train, tram, Other,
Site participants data class (miles) bus, taxi Car Walka cycle

London 168 85 (50.6) 1.5 17 (20.0) 24 (28.2) 42 (49.4) 4 (4.7)

Nottingham 219 126 (57.5) 3.1 11 (8.7) 93 (73.8) 32 (25.4) 0

a Some people walked and took the bus, so totals by mode exceed 100%.

TABLE 32 Falls Management Exercise programme opportunity costs

What gave up doing to attend class (opportunity cost),

number (%) of participants
Number (%)
Number of providing Voluntary Home
Site participants data Employment work making Caring Recreation Other
London 168 44 (26.2) 0 6 (13.6) 14 (31.8) 2 (4.5) 20 (45.5) 2 (4.5)

Nottingham 219 63 (28.8) 2 (3.2) 2 (3.2) 23 (36.5) 4 (6.3) 26 (41.3) 6 (9.5)

Service use
Data on primary care service use covering the 6 months of the intervention and 12 months post-intervention
follow-up period were collected from all 21 GP practices (594 participants – 194 FaME, 168 OEP, 232 usual
care) in Nottingham, and 19 out of 22 practices (500 participants – 161 FaME, 186 OEP, 153 usual care) in
London (access was denied by the other three). Group comparisons of primary care contacts and associated
costs were conducted to explore possible impacts of exercise on general health and were offset against the
costs of the interventions. Both parametric and non-parametric methods were used to compare group
utilisation and costs. Inspection of the histograms showed that total contact and total cost distributions
approached normality with few outliers, so the results of the parametric approach are reported. The findings
from the non-parametric approach revealed no differences in the findings.

Taking London and Nottingham together (Table 33), there was a tendency for the mean number of
primary care contacts to be higher in the OEP group, compared with usual care (p=0.100), largely as a
result of utilisation in Nottingham, but no differences between the other groups. In London, the mean
of total contacts was significantly higher in the FaME group than in the usual-care group (p=0.037)
(Table 34). Table 35 shows primary care service use per participant, during the 6-month intervention and
the 12-month follow-up in Nottingham.

Regarding costs of primary care service utilisation, taking London and Nottingham together, there was a
tendency (p=0.104) for the mean costs in the FaME group to be higher than that in the usual-care group,
but no significant difference between the other groups. In Nottingham, the mean cost of services used in
OEP tended to be higher than that of usual care (p=0.095) (Table 36).

Falls
Data on falls and A&E and hospital service utilisation associated with falls were collected from GP records
at the same time as primary care contact information. The numbers of falls documented are therefore
different from those reported in Chapter 6, which were reported in diaries and at telephone follow-up. No
differences were found in number of GP-recorded falls, or the A&E and hospital costs associated with falls,
between any groups at either site (Table 37).

60
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SO16 7NS, UK.
TABLE 33 Primary care service use per participant, during the 6-month intervention and the 12-month follow-up: London and Nottingham combineda
DOI: 10.3310/hta18490

Mean t-test for equality of means, p-value; 95% CIs of difference between means

FaME OEP Usual care

Service Variable (N=350) (N=346) (N=381) OEP vs. usual care FaME vs. usual care FaME vs. OEP

GP Number of contacts at practice 7.98 7.68 7.70 0.959; –9.440 to –0.895 0.565; –0.673 to 1.232 0.531; –0.648 to 1.256
Number of home visits 0.29 0.18 0.13 0.406; –0.069 to 0.171 0.015; 0.030 to 0.279 0.205; –0.057 to 0.264

Number of telephone calls 1.45 0.81 0.82 0.956; –0.351 to 0.332 0.005; 0.192 to 1.079 0.002; 0.244 to 1.046

Total GP contacts 9.72 8.67 8.65 0.976; –1.071 to 1.105 0.087; –0.157 to 2.295 0.086; –0.150 to 2.255

Practice nurse Number of contacts at practice 3.49 3.36 3.42 0.839; –0.624 to 0.507 0.815; –0.551 to 0.699 0.678; –0.495 to 0.761

Number of home visits 0.01 0.04 0.00 0.141; –0.014 to 0.095 0.238; –0.006 to 0.023 0.261; –0.088 to 0.024

Number of telephone calls 0.18 0.25 0.10 0.008; 0.035 to 0.254 0.081; –0.010 to 0.171 0.314; –0.192 to 0.062
(n=349) (n=380)

Total practice nurse contacts 3.64 3.36 3.53 0.676; –0.459 to 0.708 0.728; –0.523 to 0.749 0.973; –0.661 to 0.639
(n=349) (n=380)

Out of hours Number of treatment centre visits 0.07 0.08 0.04 0.148; –0.014 to 0.092 0.261; –0.018 to 0.066 0.612; –0.074 to 0.044

Number of home visits 0.01 0.04 0.02 0.134; –0.007 to 0.051 0.648; –0.023 to 0.014 0.078; –0.055 to 0.003
(n=345)

Number of telephone calls 0.07 0.09 0.08 0.936; –0.063 to 0.069 0.551; –0.078 to 0.042 0.454; –0.076 to 0.034

Total out-of-hours contacts 0.15 0.21 0.14 0.208; –0.036 to 0.165 0.976; –0.086 to 0.089 0.216; –0.163 to 0.037
(n=345)
continued

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suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR
HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
61
 62
TABLE 33 Primary care service use per participant, during the 6-month intervention and the 12-month follow-up: London and Nottingham combineda (continued )
ECONOMIC ANALYSIS

Mean t-test for equality of means, p-value; 95% CIs of difference between means

FaME OEP Usual care

Service Variable (N=350) (N=346) (N=381) OEP vs. usual care FaME vs. usual care FaME vs. OEP

Other senior-level Number of contacts at practice 0.07 0.32 0.17 0.102; –0.029 to 0.318 0.056; –0.206 to 0.002 0.003; –0.409 to –0.084
practitionersb

NIHR Journals Library www.journalslibrary.nihr.ac.uk

Number of home visits 0.05 0.44 0.00 0.019; 0.072 to 0.807 0.144; –0.017 to 0.114 0.040; –0.764 to –0.017

Number of telephone calls 0.02 0.05 0.04 0.727; –0.049 to 0.068 0.226; –0.064 to 0.015 0.247; –0.094 to 0.024
Other middle-level Number of contacts at practice 0.16 0.12 0.03 0.022; 0.012 to 0.156 0.002; 0.047 to 0.204 0.406; –0.57 to 0.140
practitionersb
Number of home visits 0.05 0.01 0.03 0.072; –0.048 to 0.002 0.446; –0.031 to 0.071 0.083; –0.006 to 0.091

Number of telephone calls 0.00 0.00 0.00 0.318; –0.003 to 0.009 N/A 0.318; –0.009 to 0.003

Other lower-level Number of contacts at practice 1.30 1.70 1.19 0.017; 0.093 to 0.923 0.569; –0.258 to 0.470 0.080; –0.853 to 0.048
practitionersb
Number of home visits 0.00 0.08 0.01 0.067; –0.005 to 0.157 0.696; –0.014 to 0.010 0.058; –0.159 to 0.003

Number of telephone calls 0.01 0.03 0.02 0.471; –0.018 to 0.038 0.648; –0.023 to 0.014 0.329; –0.044 to 0.015

Total OPC (all three levels) 1.66 2.75 1.50 0.001; 0.525 to 1.980 0.442; –0.259 to 0.593 0.005; –1.840 to –0.331

Grand total Number of contacts 15.06 15.27 13.85 0.100; –0.270 to 3.103 0.146; –0.494 to 2.914 0.829; –2.082 to 0.669
(n=349) (n=345) (n=380)
N/A, not applicable; OPC, other practitioner contacts.
a Based on 1077 participants (out of 1094), for whom we have complete data (eight missing from OEP, five missing from FaME and four missing from usual care). Small discrepancies may
arise between the sum of item means and the totals shown because of sporadic missing data.
b Senior-level practitioners (community matron, specialist nurse, counsellor, pharmacist); middle-level practitioners (district nurse, allied health professionals); lower-level practitioners
(health-care assistant, support worker, phlebotomist, podiatrist).
SO16 7NS, UK.
TABLE 34 Primary care service use per participant, during the 6-month intervention and 12-month follow-up: Londona
DOI: 10.3310/hta18490

Mean t-test for equality of means, p-value; 95% CIs of difference between means

FaME OEP Usual care

Service Variable (N=158) (N=180) (N=151) OEP vs. usual care FaME vs. usual care FaME vs. OEP
GP Number of contacts at practice 8.41 8.74 8.85 0.526; –1.944 to 1.169 0.560; –1.963 to 1.065 0.933; –1.500 to 1.376

Number of home visits 0.07 0.06 0.11 0.320; –0.134 to 0.044 0.413; –0.124 to 0.051 0.818; –0.064 to 0.081

Number of telephone calls 2.23 0.83 0.75 0.700; –0.322 to 0.479 0.000; 0.771 to 2.187 0.000; 0.667 to 2.135

Total GP contacts 10.71 9.36 9.72 0.681; –2.047 to 1.339 0.301; –0.895 to 2.882 0.142; –0.455 to 3.150

Practice Nurse Number of contacts at practice 4.51 3.65 3.16 0.194; –0.251 to 1.233 0.007; 0.378 to 2.317 0.091; –0.139 to 1.851

Number of home visits 0.01 0.01 0.00 0.158; –0.004 to 0.027 0.319; –0.006 to 0.019 0.641; –0.025 to 0.015

Number of telephone calls 0.18 (n=157) 0.37 0.13 (n=150) 0.019; 0.039 to 0.027 0.522; – 0.120 to 0.236 0.129; –0.417 to 0.053
Total practice nurse contacts 4.60 (n=157) 4.03 3.29 (n=150) 0.066; 0.048 to 1.517 0.010; 0.313 to 2.298 0.277; –0.460 to 1.602

Out of hours Number of treatment centre visits 0.03 0.02 0.05 0.174; –0.073 to 0.013 0.589; –0.068 to 0.039 0.464; –0.025 to 0.055

Number of home visits 0.01 0.02 0.01 0.831; –0.028 to 0.035 0.964; –0.026 to 0.025 0.798; –0.035 to 0.027

Number of telephone calls 0.05 0.05 0.04 0.676; –0.038 to 0.059 0.703; –0.045 to 0.067 0.983; –0.057 to 0.058

Total out-of-hours contacts 0.09 0.08 0.10 0.708; –0.100 to 0.068 0.926; –0.098 to 0.089 0.806; –0.081 to 0.105
continued

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suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR
HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
63
 64
TABLE 34 Primary care service use per participant, during the 6-month intervention and 12-month follow-up: Londona (continued )
ECONOMIC ANALYSIS

Mean t-test for equality of means, p-value; 95% CIs of difference between means

FaME OEP Usual care

Service Variable (N=158) (N=180) (N=151) OEP vs. usual care FaME vs. usual care FaME vs. OEP
Other senior-level Number of contacts at practice 0.12 0.07 0.02 0.345; –0.051 to 0.144 0.098; –0.019 to 0.219 0.456; –0.088 to 0.195
practitionersb

NIHR Journals Library www.journalslibrary.nihr.ac.uk

Number of home visits 0.01 0.00 0.00 N/A 0.319; –0.006 to 0.019 0.319; –0.006 to 0.019

Number of telephone calls 0.00 0.00 0.00 N/A N/A N/A

Other middle-level Number of contacts at practice 0.06 0.04 0.02 N/A N/A N/A
practitionersb
Number of home visits 0.04 0.00 0.01 0.611; –0.054 to 0.092 0.467; –0.063 to 0.137 0.736; –0.0877 to 0.124

Number of telephone calls 0.00 0.00 0.00 0.319; –0.039 to 0.013 0.237; –0.021 to 0.083 0.052; 0.000 to 0.089

Other lower-level Number of contacts at practice 0.59 0.77 0.17 0.00; 0.315 to 0.887 0.000; 0.211 to 0.647 0.317; –0.509 to 0.165
practitionersb
Number of home visits 0.01 0.00 0.01 0.319; –0.039 to 0.013 0.633; –0.035 to 0.022 0.319; –0.006 to 0.019

Number of telephone calls 0.00 0.01 0.03 0.143; –0.049 to 0.007 0.045; –0.052 to –0.001 0.350; –0.017 to 0.006

Total OPC (all three levels) 0.83 0.88 0.26 0.000; 0.311 to 0.928 0.000; 0.280 to 0.861 0.809; –0.444 to 0.347

Grand total Number of contacts 15.98 (n=157) 14.35 13.43 (n=150) 0.400; –1.225 to 3.058 0.037; 0.158 to 4.938 0.172; –0.714 to 3.975
N/A, not applicable; OPC, other practitioner contacts.
a Based on 489 participants (out of 500), for whom we have complete data (six missing from OEP, three missing from FaME and two missing usual care). Small discrepancies may arise
between the sum of item means and the totals shown because of sporadic missing data.
b Senior-level practitioners (community matron, specialist nurse, counsellor, pharmacist); middle-level practitioners (district nurse, allied health professionals); lower-level practitioners
(health-care assistant, support worker, phlebotomist, podiatrist).
SO16 7NS, UK.
DOI: 10.3310/hta18490

TABLE 35 Primary care service use per participant, during the 6-month intervention and 12-month follow-up: Nottinghama

Mean t-test for equality of means, p-value; 95% CIs of difference between means

FaME OEP Usual care

Service Variable (N=192) (N=166) (N=230) OEP vs. usual care FaME vs. usual care FaME vs. OEP

GP Number of contacts at practice 7.64 6.83 6.95 0.23; –1.198 to 0.953 0.26; –0.531 to 1.906 0.195; –0.417 to 2.037

Number of home visits 0.46 0.31 0.15 0.173; –0.073 to 0.404 0.004; 0.103 to 0.529 0.328; –0.152 to 0.452

Number of telephone calls 0.81 0.78 0.86 0.777; –0.618 to 0.462 0.861; –.590 to 0.493 0.883; –0.363 to 0.422

Total GP contacts 8.91 7.92 7.96 0.962; –1.458 to 1.389 0.244; –0.655 to 2.565 0.227; –0.619 to 2.599

Practice nurse Number of contacts at practice 2.66 3.05 3.59 0.201; –1.377 to 0.291 0.021; –1.716 to –0.143 0.322; –1.153 to 0.380

Number of home visits 0.02 0.08 0.00 0.195; –0.038 to 0.186 0.33; –0.012 to 0.034 0.280; –0.177 to 0.051
Number of telephone calls 0.18 0.12 0.09 0.365; –0.039 to 0.106 0.030; 0.009 to 0.181 0.224; –0.038 to 0.162

Total practice nurse contacts 2.86 3.25 3.68 0.312; –1.282 to 0.411 0.047; –1.636 to –0.010 0.338; –1.183 to 0.407

Out of hours Number of treatment centre visits 0.10 0.16 0.04 0.028; 0.12 to 0.214 0.082; –0.007 to 0.118 0.309; –0.169 to 0.054

Number of home visits 0.01 0.06 (n=165) 0.02 0.090; –0.007 to 0.093 0.603; –0.033 to 0.019 0.055; –0.101 to 0.001

Number of telephone calls 0.08 0.13 0.11 0.819; –0.102 to 0.129 0.475; –0.131 to 0.061 0.320; –0.144 to 0.047

Total out-of-hours contacts 0.19 0.35 (n =165) 0.17 0.058; –0.006 to 0.349 0.844; –0.122 to 0.150 0.080; –0.335 to 0.019
continued

Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton
suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR
HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
65
 66
TABLE 35 Primary care service use per participant, during the 6-month intervention and 12-month follow-up: Nottinghama (continued )
ECONOMIC ANALYSIS

Mean t-test for equality of means, p-value; 95% CIs of difference between means

FaME OEP Usual care

Service Variable (N=192) (N=166) (N=230) OEP vs. usual care FaME vs. usual care FaME vs. OEP

Other senior-level Number of contacts at practice 0.03 0.59 0.27 0.058; –0.011 to 0.644 0.002; –0.392 to –0.093 0.000; –0.860 to –0.258

NIHR Journals Library www.journalslibrary.nihr.ac.uk

practitionersb
Number of home visits 0.09 0.92 0.00 0.019; 0.153 to 1.681 0.166; –0.035 to 0.204 0.035; –1.606 to –0.060
Number of telephone calls 0.04 0.11 0.07 0.152; –0.015 to 0.094 0.288; –0.107 to 0.032 0.201; –0.198 to 0.042

Other middle-level Number of contacts at practice 0.24 0.20 0.04 0.014; 0.032 to 0.287 0.001; 0.084 to 0.317 0.621; –0.121 to 0.203
practitionersb
Number of home visits 0.06 0.02 0.04 0.207; –0.065 to 0.014 0.736; –0.067 to 0.094 0.373; –0.047 to 0.126

Number of telephone calls 0.00 0.01 0.00 0.319; –0.006 to 0.018 N/A 0.319; –0.018 to 0.006

Other lower-level Number of contacts at practice 1.88 2.71 1.87 0.021; 0.128 to 1.563 0.974; –0.573 to.593 0.036; –1.617 to –0.055
practitionersb
Number of home visits 0.00 0.17 0.00 0.049; 0.001 to 0.336 N/A 0.049; –0.336 to –0.001

Number of telephone calls 0.02 0.05 0.01 0.152; –0.015 to 0.094 0.366; –0.014 to 0.038 0.336; –0.083 to 0.028
Total OPC (all three levels) 2.35 4.78 2.31 0.000; 1.094 to 3.843 0.906; –0.632 to 0.713 0.001; –3.852 to –1.004

Grand total Number of contacts 14.31 16.27 (n=165) 14.12 0.112; –0.503 to 4.793 0.877; –2.166 to 2.537 0.187; –4.889 to 0.970
N/A, not applicable; OPC, other practitioner contacts.
a Based on 586 participants (out of 594), for whom we have complete data (two missing from OEP, two missing from FaME and two missing usual care). Small discrepancies may arise
between the sum of item means and the totals shown because of sporadic missing data.
b Senior-level practitioners (community matron, specialist nurse, counsellor, pharmacist); middle-level practitioners (district nurse, allied health professionals); lower-level practitioners
(health-care assistant, support worker, phlebotomist, podiatrist).
 TABLE 36 Costs of primary care service use (£, 2011) per participant, during the 6-month intervention and 12-month follow-up

SO16 7NS, UK.

Service Mean t-test for equality of means, p-value; 95% CIs of difference between means

Usual
FaME OEP care
DOI: 10.3310/hta18490

London and Nottingham combined (N=350) (N=346) (N=381) OEP vs. usual care FaME vs. usual care FaME vs. OEP

N=1077 with complete data (eight missing from

OEP, five missing from FaME and four missing from
usual care)

Total GP (at practice, home, telephone) 353.95 316.29 311.22 0.803; –34.79 to 44.92 0.064; –2.50 to 87.96 0.112; –8.81 to 84.13

Total practice nurse (at practice, home, telephone) 34.79 35.17 33.94 0.674; –4.52 to 6.99 0.783; –5.26 to 6.97 0.907; –6.73 to 5.97

Total out of hours (at treatment centre, 7.95 14.25 8.04 0.077; –0.67 to 13.09 0.972; –5.33 to 5.14 0.090; –13.59 to 0.980
home, telephone)

Total other primary care (at practice, home, telephone) 15.53 38.52 13.53 0.004; 7.87 to 42.11 0.428; –2.95 to 6.94 0.010; –40.33 to –5.65

Grand total 412.22 404.23 366.73 0.188; –17.70 to 89.96 0.104; –8.57 to 91.14 0.866; –54.73 to 65.07
Usual
FaME OEP care
London only (N=158) (N=180) (N=151) OEP vs. usual care FaME vs. usual care FaME vs. OEP

N=489 with complete data (six missing from OEP,

three missing from FaME and two from missing
usual care)

Total GP (at practice, home, telephone) 360.16 330.53 348.19 0.561; –77.42 to 42.10 0.711; –51.50 to 75.44 0.337; –31.00 to 90.26

Total practice nurse (at practice, home, telephone) 44.02 37.62 31.47 0.102; –1.23 to 13.54 0.009; 3.10 to 22.01 0.197; –3.34 to 16.14
(n=157) (n=150)

Total out of hours (at treatment centre, 5.68 5.58 6.22 0.859; –7.74 to 6.45 0.869; –6.99 to 5.90 0.978; –7.10 to 7.31
home, telephone)

Total other primary care (at practice, home, telephone) 9.03 6.97 2.38 0.003; 1.55 to 7.63 0.001; 2.21 to 10.70 0.381; –2.57 to 6.70

Grand total 418.89 380.70 388.26 0.761; –74.12 to 54.25 0.546; –46.98 to 88.66 0.357; –34.83 to 96.38
(n=157) (n=150)
continued

Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton
suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR
HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
© Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
67
 68
TABLE 36 Costs of primary care service use (£, 2011) per participant, during the 6-month intervention and 12-month follow-up (continued )

Service Mean t-test for equality of means, p-value; 95% CIs of difference between means
ECONOMIC ANALYSIS

Usual
FaME OEP care
Nottingham only (N=192) (N=166) (N=230) OEP vs. usual care FaME vs. usual care FaME vs. OEP
N=586 with complete data (two missing from
OEP, two missing from FaME and two missing

NIHR Journals Library www.journalslibrary.nihr.ac.uk

usual care)

Total GP (at practice, home, telephone) 348.84 300.84 286.95 0.614; –40.26 to 68.06 0.052; –0.41 to 124.19 0.181; –22.48 to 118.47

Total practice nurse (at practice, home, telephone) 27.25 32.51 35.55 0.484; –11.54 to 5.47 0.039; –16.18 to –0.42 0.205; –13.41 to 2.88
(n=165)

Total out of hours (at treatment centre, 9.81 23.71 9.23 0.018; 2.49 to 26.46 0.884; –7.21 to 8.36 0.033; –26.63 to –1.16
home, telephone)
Total other primary care (at practice, home, telephone) 20.88 72.73 20.86 0.004; 17.12 to 86.63 0.996; –7.805 to 7.844 0.004: –86.93 to –16.78

Grand total 406.78 429.79 352.59 0.095; –13.37 to 165.95 0.128; –15.73 to 124.20 0.622; –121.35 to 77.15
(n=165)
Unit costs data from Curtis.74
GP: contacts at practice, £36.00 (11.7 minutes); home visits, £121.00 (23.4 minutes); telephone calls, £22.00 (7.1 minutes).
Practice nurse: contacts at practice, £9.75 (15.5 minutes); home visit, £28.47 (based on district nurse home visit £73/hour and GP 23.4-minute visit time); telephone calls, £4.68 (based on
GP 7.1-minute telephone call time).
Out of hours: treatment centre visits, £54.00 [based on GP 11.7 minutes surgery consultation, adjusted (×1.5) for unsocial hours]; home visits £181.50 [based on GP 23.4 home visit time,
adjusted (×1.5) for unsocial hours]; telephone calls £33.00 [based on GP 7.1-minute telephone call time, adjusted (×1.5) for unsocial hours].
Other primary care, senior (advanced nurse): surgery consultations, £25.00 (15 minutes); home visits, £38.22 (25 minutes at £91 per hour); telephone calls, £5.90 (6 minutes at
£59 per hour).
Other primary care, middle (community nurse): surgery consultations, £13.00 (based on practice nurse 15.5 minute consultation time); home visits, £28.47 (travel included, based on GP
23.4-minute home visit time); telephone call, £5.50 (using GP 7.1-minute telephone calls).
Other primary care, lower [clinical support worker nursing (community)]: surgery consultations, £6.24 (based on practice nurse 15.5 minutes consultation time); home visits, £11.31
(based on GP 23.4-minute home visits time); telephone calls, £2.40 (based on GP 7.1-minute telephone call time).
SO16 7NS, UK.
TABLE 37 Falls per participant, during the 6-month intervention and 12-month follow-up, captured from GP records

Variable Mean t-test for equality of means, p-value; 95% CIs of difference between means

London and Nottingham combined FaME (N=355) OEP (N=354) Usual care (N=385) OEP vs. usual care FaME vs. usual care FaME vs. OEP
DOI: 10.3310/hta18490

Number of falls 0.12 (n=350) 0.17 (n=346) 0.14 (n=379) 0.548; –0.063 to 0.119 0.645; –0.089 to 0.055 0.136; –0.132 to 0.043

Number of A&E visits for falls 0.06 (n=350) 0.07 (n=347) 0.06 (n=379) 0.423; –0.028 to 0.067 0.823; –0.036 to 0.045 0.534; –0.062 to 0.032

Number of hospital admissions for falls 0.01 (n=350) 0.03 (n=347) 0.02 (n=380) 0.351; –0.014 to 0.040 0.613; –0.021 to 0.013 0.215; –0.045 to 0.010

Number of inpatient nights for falls 0.01 (n=351) 0.16 (n=348) 0.05 (n=380) 0.413; –0.155 to 0.377 0.325; –0.115 to 0.038 0.271; –0.416 to 0.117
Total cost of falls (A&E and nights) 12.63 (n=350) 39.20 (n=347) 19.27 (n=379) 0.305; –18.24 to 58.08 0.461; –24.33 to 11.05 0.146; –62.42 to 9.3

London only FaME (N=161) OEP (N=186) Usual care (N=153) OEP vs. usual care FaME vs. usual care FaME vs. OEP

Number of falls 0.17 (n=158) 0.17 (n=180) 0.19 (n=151) 0.755; –0.137 to 0.100 0.819; –0.139 to 0.110 0.942; –0.110 to 0.118

Number of A&E visits for falls 0.09 (n=158) 0.08 (n=180) 0.06 (n=151) 0.539; –0.052 to 0.100 0.393; –0.038 to 0.096 0.892; –0.071 to 0.082

Number of hospital admissions for falls 0.02 (n=158) 0.02 (n=180) 0.01 (n=151) 0.600; –0.025 to 0.043 0.690; –0.023 to 0.034 0.855; –0.038 to 0.032

Number of inpatient nights for falls 0.02 (n=159) 0.28 (n=181) 0.10 (n=151) 0.552; –0.407 to 0.761 0.378; –0.260 to 0.099 0.354; –0.803 to 0.288

Total cost of falls (A&E and nights) 19.82 (n=158) 50.78 (n=180) 25.41 (n=151) 0.502; –48.89 to 99.63 0.761; –41.77 to 30.58 0.369; –98.64 to 36.7
Nottingham only FaME (N=194) OEP (N=168) Usual care (N=232) OEP vs. usual care FaME vs. usual care FaME vs. OEP

Number of falls 0.08 (n=192) 0.17 (n=166) 0.11 (n=228) 0.396; –0.077 to 0.196 0.547; –0.112 to 0.059 0.231; –0.225 to 0.055

Number of A&E visits for falls 0.04 (n=192) 0.07 (n=167) 0.05 (n=228) 0.675; –0.049 to 0.075 0.525; –0.066 to 0.034 0.327; –0.088 to 0.030

Number of hospital admissions for falls 0.01 (n=192) 0.04 (n=167) 0.02 (n=229) 0.393; –0.024 to 0.061 0.249; –0.303 to 0.009 0.181; –0.076 to 0.014

Number of inpatient nights for falls 0.01 (n=192) 0.04 (n=167) 0.02 (n=229) 0.393; –0.024 to 0.061 0.227; –0.032 to 0.008 0.181; –0.076 to 0.014

Total cost of falls (A&E and nights) 6.72 (n=192) 26.71 (n=167) 15.21 (n=228) 0.433; –17.32 to 40.31 0.259; –23.24 to 6.27 0.188; –49.79 to 9.82
74
Unit costs data from Curtis.
Hospital: visits to A&E (no admissions), £106; nights in hospital, £2334 for >2 days, £549 for 1 day.

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69
 ECONOMIC ANALYSIS

Cost-effectiveness analysis

The primary outcome for the economic evaluation was to be QALYs derived from transformation of SF-12,
as described in the methods. The main analysis failed to find a significant difference between groups in
this outcome, with or without imputation, and after adjusting for baseline values, cluster and other
confounders. As a result, the economic analysis focused on cost-effectiveness using the primary clinical
outcome, i.e. the proportion of people reaching or exceeding 150 minutes of MVPA per week at
12 months after the end of the intervention.

A significant effect in favour of FaME, compared with usual care, was identified by the main statistical
analysis (see Chapter 5). Against 38% of patients receiving usual care who at least met the exercise target
at 12 months post intervention, an OR of 1.78 was associated with FaME, meaning that 52% of
participants assigned to that group would be meeting the target, an absolute increase of 14%. This
benefit was achieved through NHS expenditure on delivering the FaME interventions in London and
Nottingham of £268.75 and £218.43 per participant, respectively (mean £243.59).

A cohort of 100 people assigned to the FaME intervention would therefore incur a total cost to the NHS of
£26,875 in London and £21,843 in Nottingham (average £24,359), compared with no cost for usual care.
As the FaME programme, compared with usual care, results in 14% more people achieving or exceeding
the 150-minute per week moderate or vigorous exercise target at the 12-month post-intervention end
point, the cost per extra person exercising can be calculated as the total cost for 100 people divided by 14,
i.e. £1919.64 in London and £1560.21 in Nottingham (mean £1739.93).

Discussion

These findings need to be interpreted with caution. The per-participant costs for FaME are based on those
recorded in the trial and would be affected by class size, with smaller groups increasing the average costs.
Class size (and instructor) might also affect compliance and outcomes, but the impact of these factors is
not known. The difference in costs between sites is largely a reflection of the higher costs of facilities hired
for group classes in London, but considerable variability was observed within both sites.

The calculations reflect the NHS perspective and do not take account of the expenditures incurred by
individuals in travelling to the exercise class venues or other out-of pocket expenses associated with
exercise. No allowances are made for offsets against the costs of the interventions because no differences
were found between groups in the costs of primary care contacts (used as an indicator or general health
effects of exercise) or injurious falls in the 18 months post recruitment. The lack of difference between
groups in use of primary care utilisation is consistent with the finding of no difference in health-related
quality of life between groups.

Data from participants returning diaries indicated that those in the FaME group reported fewer falls than
those in the usual-care group in the 12 months post intervention, but this was not reflected in the GP data
(which covered all participants in GP practices that permitted access for data gathering, i.e. all practices
except for three in London). Owing to lack of a statistically significant difference in QALYs between
groups, a probabilistic sensitivity analysis was not undertaken, so no interpretation of the findings against a
cost/QALY gained benchmark is possible. The study recruited volunteers, some of whom were already
achieving the 150 minutes of MVPA at baseline. Further analysis is needed to explore the differential
impact of the interventions on sustaining exercise among those already at target, and encouraging people
not exercising to start, since this may impact on the cost-effectiveness ratios.

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Chapter 8 Discussion

What this study shows

Exercise classes using the FaME programme significantly increased PA in older people. The proportions
reporting at least 150 minutes of MVPA per week rose from 40% at baseline to 49% at 12 months
post intervention in the FaME arm, from 41% to 43% in the OEP arm and from 37.5% to 38.0% in the
usual-care arm. The odds of reporting at least 150 minutes of MVPA were 78% higher in the FaME arm
than in the usual-care arm, equating to an absolute increase of 14% in the number of participants
reaching or exceeding the PA target. In terms of minutes of MVPA, the FaME arm reported an additional
13–15 minutes of MVPA per day (91–105 minutes per week) compared with the usual-care arm,
depending on the imputational model used. There was no statistically significant increase in MVPA
in the OEP arm compared with the usual-care arm.

In the 12 months post intervention there was a statistically significant reduction in the rate of falls in the
FaME arm compared with usual care (IRR 0.74, 95% CI 0.55 to 0.99; p=0.042). Although the falls rate was
lower in the OEP arm than in the usual-care arm, there was no statistically significant difference between
these two arms. The PASE scores showed a small, but statistically significant, benefit for FaME compared
with usual care (difference in means 11.2, 95% CI 0.2 to 20.2; p=0.046), but no statistically significant
benefit for OEP (difference in means 7.5, 95% CI –3.8 to 18.8; p=0.20). Significant improvements were
seen in balance confidence for both intervention arms at 12 months post intervention. The mean difference
for FaME compared with usual care was –0.529 (95% CI –0.998 to –0.061; p=0.027), while the mean
difference for OEP compared with usual care was –0.545 (95% CI –1.033 to –0.057; p=0.029). Participants
in the FaME and OEP arms were significantly less likely to dismiss exercise as not beneficial, and in the FaME
arm were more likely to be positive about exercise, 12 months after the end of the interventions.

There were no statistically significant differences between intervention arms and the usual-care arm in
self-efficacy, mental and physical well-being, quality of life, social networks, falls risk or functional abilities.
The lack of change in quality of life is perhaps not surprising, given the high baseline level of OPQoL scores
and the limited likelihood that an extra 15 minutes of PA in relatively active people would change
perceptions of quality of life. The interventions were not associated with increased risk of AEs or ARs,
during or, after the intervention period.

FaME is more expensive than OEP delivered with PMs (£269 vs. £88 per participant in London; £218 vs.
£117 per participant in Nottingham), because of more direct participant contact from PSIs and hire of halls
for the exercise classes. The cost per additional person meeting the target of 150 minutes MVPA per week
at 12 months post intervention in FaME, compared with usual care, is £1920 in London and £1560
in Nottingham.

There are a number of methodological lessons from this trial. We have demonstrated that it is possible to
recruit older people who would benefit from increasing their PA (as shown by their performance on a
range of functional and psychological measures) to exercise promotion trials in general practice. As we
outlined in Chapter 3, organisational factors in practices (such as room availability and space to carry out
functional assessments) mean that planned recruitment rates may overestimate the speed of recruitment.
Given that participation in an exercise trial attracts some who are already physically active at or above
the recommended target level, telephone prescreening is useful to minimise the conduct of baseline
assessments on individuals who are subsequently found to be ineligible. Quality assurance of interventions
is necessary to optimise the fidelity of their application. The quality assessment process developed for the
FaME intervention proved workable and may be of use in other similar studies. Recruitment of PMs was
difficult despite relaxing the eligibility rules and the OEP arm was disadvantaged by this. Finally, frequent

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 DISCUSSION

request of participants to complete exercise diaries challenged retention, and we lessened this research
burden by reducing the frequency of requests. We will return to these methodological issues later in
this chapter.

As we described in Chapter 4, those recruited to the trial were more active than their peers (with a median
weekly MVPA level at baseline of 105 minutes), but on other characteristics functioned below population
norms. Although not inactive, in other respects the participant population was an ideal one for testing PA
interventions, as noted above. Retention of trial participants in the study remained problematic, despite
the efforts made to increase it described in Chapter 3. However, this may in part be an unavoidable
consequence of targeting an older age group, as illness events are common in the older population; 30%
of those who dropped out cited illness as their reason for discontinuing with the study. Disappointment at
allocation and research burden (the number of questionnaires and diaries to complete – see above and
Chapter 3) were responsible for at least 18% and 11% of dropouts, respectively. As Chapter 4 shows,
those who dropped out were older and more disabled than those who remained in the study. Those lost
to follow-up were the subgroup which would probably have benefited most from increasing PA and may
have been those least likely to increase their MVPA as a result of the intervention. This suggests that
post-intervention levels of MVPA may overestimate activity levels that could be achieved in the general
population of older people with delivery of FaME and OEP programmes. However, as losses to follow-up
were similar across treatment arms, it is unlikely that this will have biased our estimates of the difference in
MVPA between treatment arms.

Comparison with other studies

Our systematic review of the effectiveness of PA interventions for adults aged ≥50 years delivered through
general practice84 identified six studies published between 1998 and 2011, with a total of 1522 participants.
Four interventions were delivered by GPs or nurses and exercise specialists.85–88 Three used only exercise
specialists86,89 or an exercise counsellor.90 Two used specific PA measures, such as the PASE and the Auckland
Heart Exercise Questionnaire.89,90 Four studies had 12 months’ follow-up.86–89 Only two of these studies
reported a statistically significant increase in PA levels. Kolt et al.90 report that moderate-leisure PA increased
by 86.8 minutes per week in the intervention participants compared with controls (p=0.007). More
intervention participants than controls reached 2.5 hours per week of moderate/vigorous leisure physical
activity at 12 months (42% vs. 23%; OR 2.9, 95% CI 1.33 to 6.32; p=0.007). Halbert et al.86 reported that
PA increased in both groups (p<0.05), but more participants in the intervention group than in the control
group increased their intention to do PA (p<0.001). The increase was greater in the intervention than in the
control group for all measures, except time spent walking. Two studies showed no significant increase
in activity.85,88

The ProAct65+ trial almost doubles the number of participants in such studies and shows the impact of
interventions using standard scales for assessing PA for up to 2 years post randomisation. In contrast to the
methodological variability of the other six studies, the ProAct65+ trial reported the method for generating
the randomisation sequence, concealment of allocation, blind assessment of outcomes, an intention-to-treat
analysis controlled for confounding variables and differences between treatment groups at baseline. In the
six other studies, all interventions left participants to motivate and organise their own PA and the quantity of
PA undertaken was not monitored, making it difficult to know whether or not the dose of the intervention
affected the results. The effectiveness of the FaME arm in increasing self-reported PA may reflect the direction
and encouragement provided by PSIs to participants.

Strengths and limitations of the study

To the best of our knowledge this study is the largest general practice-based trial of exercise interventions
for older people in the UK, to date, and the first to deploy PMs to augment an exercise programme.

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Both exercise interventions were evidence based, but also pragmatic (i.e. feasible to use in general
practice), and tailored to individual participants’ capabilities.

The ProAct65+ trial largely fulfils the RE-AIM criteria for evaluation of the public health impact of health
promotion studies, using five dimensions:91

1. Reach (the proportion of the target population reached and the characteristics of participants
compared with the target population). The ProAct65+ trial recruited a large number of people aged
≥65 years, whose performance on most of the measures used fell below population norms, despite
their relatively high level of PA at baseline. The trial attracted participants who would be likely to
benefit from increasing their PA level.
2. Efficacy (how the intervention benefited the participants). Participants in the FaME arm reported
increased physical activity (on two measures), had a lower risk of falls and improved balance
confidence, as well as becoming more positive about the beneficial effects of exercise. These findings
are consistent with the conclusions of the Cochrane review of falls prevention.5
3. Adoption (engagement of the settings participating in the study). Recruitment through general practice
was feasible and 70% of participants remained in the study for 1 year after the intervention period.
4. Implementation (the extent to which the intervention was delivered as intended; including the
adherence to the intervention, and the involvement of staff in the setting). Adherence to the
intervention was easier to maintain in the FaME arm than in the OEP arm. As reported in Chapter 5, we
were unable to show any difference in outcome in either intervention arm attributable to adherence.
5. Maintenance (long-term maintenance of behaviour change, defined as ≥2 years). We have reported
findings at 12 months post intervention, our predetermined analysis point, but have collected data for
up to 24 months post intervention. Significant increases in self-reported MVPA were found in the FaME
arm of this study at 12 months post intervention (18 months after allocation); as Chapter 5 shows, this
increase persisted, although slightly attenuated, at 18 months post intervention (2 years post
allocation). Further studies are needed to measure attenuation of effects and to test the impact of
reinforcement of the intervention.

Because of the difficulties of recruiting sufficient PMs we were unable to ensure a consistent dose of peer
mentoring, which means that we have not measured the true impact of the OEP intervention.

The trial was reliant on self-report of PA, which is criticised for overestimating actual levels of activity.92
However, this is less of a limitation than some suggest, for several reasons.

First, associations between self-reported PA and health outcomes93 are the basis of guidelines on 150 minutes
of MVPA94 and, therefore, self-report of PA is also an appropriate measure of change in behaviour.95 Using
objective measures to assess compliance with guidelines that are based on evidence from self-reported activity
could give an inaccurate picture of the proportion of the population that is insufficiently active.94

Second, self-reported engagement in activities predicts both self-reported and measured functional ability
3–5 years later96 and all-cause mortality in middle-aged men 21 years later.97 Self-reported PA scales can
have acceptable validity98 and a single question can reflect a physiological measure like VO2max.99

Third, it appears that social desirability may influence self-reporting of PA, but this bias may also be
determined by the type of questions asked100 and the characteristics of respondents. For example,
misperception of activity level in one study was associated with older age, female sex, poorer walking
performance, lower social support and lower self-efficacy,101 while another found that the difference
between self-report and objectively measured MVPA was greatest among older men with lower
educational level, at higher activity and intensity levels.101 In the ProAct65+ trial the treatment arms were
well balanced, and factors known to be associated with reporting PA were similar across treatment arms,
suggesting social desirability to report PA might be expected to be similar across treatment arms. In
addition, although those who were less active at baseline were more likely to withdraw, attrition did not

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 DISCUSSION

vary significantly between treatment arms, again, suggesting this should not have resulted in differential
reporting of PA between treatment arms.

Finally, although self-reported PA may overestimate objectively measured PA, this finding has not been
consistent across studies. Some of the discrepancies between self-reported and objectively measured PA
are because subjective and objective measures of PA are actually measuring different aspects of activity
that are independently associated with biomarkers.102 For example, PA monitors cannot accurately assess
upper-body activities or account for movements that require extra effort, such as walking uphill or carrying
loads.103 Overall, it is not yet possible to draw definitive conclusions about the validity of self-reporting of
PA compared with objective measurement,104 and this is an important research topic needing
further investigation.

Lessons learned

The challenges faced during the ProAct65+ trial and solutions to these challenges are summarised in
Chapter 3. Other research which has faced similar challenges is discussed here, and implications for future
research and public health practice are suggested.

Although the trial exceeded its recruitment target, the recruitment process was more difficult and slower
than anticipated. The time needed to recruit participants was underestimated and an extension in
recruitment time was needed. Other trials recruiting from general practice have found similar slow and
difficult recruitment, with lower than anticipated numbers recruited and required time extensions.105–107 In
ProAct65+, the recruitment phase was extended, more general practices were recruited and more patients
at each practice were invited to participate to achieve the target numbers. We learned that it is advisable
to keep recruitment as straight forward as possible and to minimise the work demanded of
general practices.108

Expressions of interest were received from patients already exercising at the target level of 150 minutes of
moderate activity per week, and from frequent fallers. Others have reported that exercise trials can attract
the more active part of the population.109 Telephone prescreening was introduced to exclude such patients
before they reached the baseline assessment appointment, but further studies are needed of ways to
recruit the less active population.

The use of volunteers to act as PMs proved complicated. As others have found with interventions using
volunteers, recruitment can be slow and the numbers deployed may be low.110 Our PMs had a case load
lower than we planned and, because we also had fewer PMs than intended, some participants received
little or no PM support. Other studies have also encountered these problems.111–113 The lower age limit for
PMs was reduced, as was the frequency of their contacts with participants, but with only limited benefit to
PM recruitment. It will be important for future interventions testing peer mentoring to allow enough time
and resources (human and financial) when planning recruitment and training programmes. In order to
minimise the time from training a PM to deployment, and to retain interested volunteers, attention needs
to be focused on speeding up the process of gaining Criminal Records Bureau checks and Research
Management and Governance approvals. Strategies to optimise PM motivation and involvement need
further investigation.

In addition, the number of supportive contacts between PMs and participants varied and often differed
from the number of contacts advised by the research team, which may reflect the needs of the individual
participants. Future projects implementing PM support should be aware of participants’ needs for more or
less support, which may lead to varied numbers of contacts with PMs. Overall, our experience of recruiting
and retaining PMs within a trial raises questions about the feasibility of doing this in routine provision of
exercise programmes in the community. Community-based exercise programmes proposing to use PMs
should explore the feasibility of this prior to embarking on the programme.

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Failure to ensure the fidelity of interventions is an important source of variation affecting the credibility and
utility of research.114 Quality assurance observation visits to classes were carried out by expert instructors,
with verbal and written feedback on performance. Exercise instructors may not always achieve a balance
between tailoring exercise and providing a standardised programme, and observations of intervention
delivery are recommended.115

Participants can be burdened by frequent data collection, which can impact on response rates to
self-completion questionnaires and falls diaries. Response biases may occur, and we found that those with
lower educational attainment and those whose first language is not English were less likely to complete
falls diaries.78 Compromises in the frequency of data collection were made, and the frequency of the
self-completion questionnaires and diaries was reduced. However, maintaining between-assessment
contacts is important to reduce attrition.116 Personal contact with the research team improves response
rates,117 as do reminders, incentives and printed educational materials.118,119 Home visits to collect
follow-up data are useful and can reduce attrition bias in longitudinal studies.120 Alternatively, higher
response rates to postal questionnaires have been found when they are sent by the general practices
rather than by the research team; this may also be a method to aid retention of participants during a trial.121

The classification of safety events between sites was variable, so a method of cross-checking and
standardisation was developed. Both site principal investigators reviewed and discussed discrepancies in
categorisation and a new possible AR category was introduced to reduce variability. This method of
cross-checking and the classifications of safety events used in ProAct65+ could be applied to future
exercise or indeed any multisite trials.

The ProAct65+ trial was a large pragmatic RCT, which, despite difficulties, reached its recruitment target,
making it the largest exercise trial in UK general practice to date. The research team’s flexibility in being
able to adapt to unexpected problems may have led to the successful implementation of the trial.106 The
lessons learnt during the ProAct65+ trial have been valuable and have potential implications for similar
trials in general practice.

Conclusions

Our first hypothesis, that both exercise interventions would increase self-reported PA, has been refuted
in this study, as has the second, that the OEP intervention would be more cost-effective. The FaME
intervention increased self-reported PA, adding almost 15 minutes per day of MVPA. This effect persisted
for 12 months after cessation of classes. The cost of getting one person to achieve or exceed the target
level of PA was between £1560 (Nottingham) and £1920 (London). The OEP arm participants did not
show any statistically significant increase in self-reported PA 12 months post intervention. This may be as a
result of the limited support from PMs experienced by many participants in the OEP arm, and needs
further investigation.

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Acknowledgements
D aniel Jackson and Caragh Flannery contributed to the economic analysis, and Laura Perry explored
factors associated with completion of falls diaries. Mirilee Pearl and Kalpa Kharicha acted as trial
managers when other staff were absent, and Philip Prah worked on the early statistical analysis planning.
Tessa Hill, Sarah Scott, Tanimola Martins, Tracey McCauley, Marie Ashmore and Caroline Mulvaney
all contributed to the implementation of this study. Peter Cass was a lay expert advisor to the trial
management group. We thank the clinical and administrative staff of the 43 practices which took part
in the trial, for their support throughout, and the PSIs and PMs, who contributed so much.

Contributions of authors

Steve Iliffe conceived and designed the study, submitted it for funding, was chief investigator for the
study and drafted this report.

Denise Kendrick conceived and designed the study, submitted it for funding, was the principal
investigator for the study in Nottingham and Derby and helped draft this report.

Richard Morris was senior statistician for the trial, led the analyses and helped draft this report.

Tahir Masud conceived and designed the study, submitted it for funding, supported implementation of
the study, and contributed to this report.

Heather Gage supported implementation of the study, led the economic analysis and contributed to
this report.

Dawn Skelton conceived and designed the study, guided the development of the exercise interventions,
and contributed to this report.

Susie Dinan guided the development of the exercise intervention and contributed to this report.

Ann Bowling supported implementation of the study, led on quality-of-life measurement and contributed
to this report.

Mark Griffin was trial statistician, supported implementation of the study and contributed to this report.

Deborah Haworth was trial manager, drove implementation of the trial at both sites and contributed to
this report.

Glen Swanwick was PPI representative on the management board, supported implementation of the
study and contributed to this report.

Hannah Carpenter co-ordinated the Nottingham research team, supported implementation of the study
and contributed to this report.

Arun Kumar supported implementation of the study, led the analysis of fear of falling and contributed to
this report.

Zoe Stevens was the trial administrator, supported implementation of the study and contributed to
this report.

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This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
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 ACKNOWLEDGEMENTS

Sheena Gawler was research associate in the London research team, supported implementation of the
study and contributed to this report.

Cate Barlow was research associate in the London research team, supported implementation of the study
and contributed to this report.

Juliette Cook was research associate in the Nottingham research team, supported implementation of the
study and contributed to this report.

Carolyn Belcher was research associate in the Nottingham research team, supported implementation of
the study and contributed to this report.

Publications

Perry L, Kendrick D, Morris R, Dinan S, Masud T, Skelton D, et al. Completion and return of fall diaries
varies with participants' level of education, first language, and baseline fall risk. J Gerontol A Biol Sci Med
Sci 2012;67:210–14. doi: 10.1093/gerona/glr175

Iliffe S, Kendrick D, Morris R, Skelton D, Gage H, Dinan S, et al. Multicentre cluster randomised trial
comparing a community group exercise programme with home based exercise with usual care for
people aged 65 and over in primary care: protocol of the ProAct 65+ trial. Trials 2010;11:6.
doi: 10.1186/1745-6215-11-6

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105. Davey R, Edwards SM, Cochrane T. Recruitment strategies for a clinical trial of community-based
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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Appendix 1 ProAct65+ adverse event report

form (from Chapter 2)

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Appendix 2 Primary outcome – modelling

physical activity (from Chapter 5)
TABLE 38 Means CHAMPS minutes moderate and Phone-FITT total score at baseline for: those with a Phone-FITT
and CHAMPS recorded at 12 months post intervention; those with a Phone-FITT but no CHAMPS recorded at
12 months post intervention; and, those with neither a Phone-FITT nor a CHAMPS recorded at 12 months
post intervention

Baseline CHAMPS Baseline Phone-FITT

Usual care FaME OEP Usual care FaME OEP

Those with a Phone-FITT and CHAMPS recorded at 12 months post intervention

Mean 216.43 182.06 220.24 38.99 39.60 42.87

SD 241.25 222.54 252.27 11.31 13.19 12.99

Number 168 153 164 167 150 160

Those with a Phone-FITT but no CHAMPS recorded at 12 months post intervention

Mean 174.42 186.75 170.16 38.54 34.80 41.52

SD 342.85 252.53 198.24 18.01 9.93 14.24

Number 43 40 61 42 43 66

Those with neither a Phone-FITT nor a CHAMPS recorded at 12 months post intervention

Mean 130.61 152.67 149.76 33.67 35.62 39.01

SD 197.02 255.98 210.87 13.46 15.23 12.72

Number 147 118 123 129 94 116

TABLE 39 Means loge(CHAMPS minutes moderate+1) at baseline for: those with a Phone-FITT and CHAMPS
recorded at 12 months post intervention; those with a Phone-FITT but no CHAMPS recorded at 12 months post
intervention; and, those with neither a Phone-FITT nor a CHAMPS recorded at 12 months post intervention

Log-baseline CHAMPS

Usual care FaME OEP

Those with a Phone-FITT and CHAMPS recorded at 12 months post intervention

Mean 4.254 3.915 4.309

SD 2.166 2.310 2.089

Number 168 153 164

Those with a Phone-FITT but no CHAMPS recorded at 12 months post intervention

Mean 3.302 3.490 4.099

SD 2.496 2.595 2.030

Number 43 40 61

Those with neither a Phone-FITT nor a CHAMPS recorded at 12 months post intervention

Mean 2.910 3.241 3.317

SD 2.554 2.508 2.514

Number 147 118 123

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 APPENDIX 2

TABLE 40 Comparison of CHAMPS score between adherers and non-adherers to the FaME intervention

FaME

CHAMPS minutes of Log-CHAMPS minutes of

moderate or greater moderate or greater
intensity activity intensity activity Multilevel modelling
(per week) 12 months (per week) 12 months log-CHAMPS (effect of
Adherence post intervention post intervention adherent vs. not)

≥75% of total expected activity (1×60 minutes’ class exercise plus 2×30 minutes’ home exercise per week for
24 weeks=total 2880 minutes). Adherent if ≥2160 minutes’ total exercise. (Assumes no diary data=0 minutes)
Number (%) Mean SD n Mean SD n Estimate 0.109

No 321 (82.95) 199.85 207.68 136 4.219 2.109 136 95% CI –0.394 to 0.613

Yes 66 (17.05) 266.58 279.95 57 4.605 2.004 57 p-value 0.670

Number 184

≥75% of total expected activity (1×60 minutes’ class exercise plus 2×30 minutes’ home exercise per week for
24 weeks=total 2880 minutes). Adherent if ≥2160 minutes’ total exercise. (Only if all six diaries completed)
Number (%) Mean SD n Mean SD n Estimate 0.017

No 130 (69.15) 217.80 205.29 100 4.527 1.896 100 95% CI –0.492 to 0.525

Yes 58 (30.85) 270.87 289.62 52 4.620 1.978 52 p-value 0.949

Number 145

TABLE 41 Comparison of CHAMPS score between adherers and non-adherers to the OEP intervention

OEP

CHAMPS minutes of Log-CHAMPS minutes of

moderate or greater moderate or greater
intensity activity intensity activity Multilevel modelling
(per week) 12 months (per week) 12 months log-CHAMPS (effect of
Adherence post intervention post intervention adherent vs. not)

≥75% of total expected activity (3×30 minutes’ home exercise per week for 24 weeks=total 2160 minutes).
Adherent if ≥1620 minutes’ total exercise. (Assumes no diary data=0 minutes)
Number (%) Mean SD n Mean SD n Estimate –0.192

No 307 (74.88) 231.29 371.24 105 4.010 2.366 105 95% CI –0.801 to 0.417

Yes 103 (25.12) 223.69 296.75 80 4.294 2.053 80 p-value 0.537

Number 178
≥75% of total expected activity (3×30 minutes’ home exercise per week for 24 weeks=total 2160 minutes).
Adherent if ≥1620 minutes’ total exercise. (Only if all six diaries completed)
Number (%) Mean SD n Mean SD n Estimate –0.271

No 108 (54.00) 235.25 390.78 79 4.117 2.279 79 95% CI –0.935 to 0.393

Yes 92 (46.00) 217.30 296.22 74 4.219 2.096 74 p-value 0.423

Number 148

PM allocated. (N.B. no information about PM allocation for n=44)

Number (%) Mean SD n Mean SD n Estimate 0.364

No 222 (60.66) 246.77 392.06 113 4.175 2.228 113 95% CI –0.388 to 1.116

Yes 144 (39.34) 201.43 239.11 70 4.059 2.288 70 p-value 0.343

Number 176

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Appendix 3 Adverse reactions (from Chapter 5)

D escription of all ARs (i.e. events related to the trial) occurring during the ProAct65+ trial.

Falls Management Exercise programme adverse reactions

‘High knee standing’ exercises made patient’s lower-back ache.

Aching pain in calf.

Cold pain in stomach and bad taste in mouth, started after first FaME class. Patient said she would see her GP.

Patient called to say the FaME exercises ‘upset his metabolism’.

Patient feels soreness in muscles and joints.

Patient fell in FaME class, no injuries, potentially as a result of adjusting to new glasses.

Potentially pulled back muscle after doing sit down weights at gym.

Pulled calf muscle while doing our home exercise session ex 3. Sore for 2 days but did not affect normal activities.

Was out power walking and pulled a muscle; did not seek medical attention; rested and massaged leg.

Fell when in FaME class, taken to A&E, let go and in evening said was OK.

Pulled muscle.

Plantar fasciitis started about a year ago and has been getting worse, (first had it 20 years ago), got worse
when started doing more walking to improve health. Recently visited podiatrist/foot surgeon (private) for a
cortisone injection into left heel.

Pulled muscle.

Knee pains so didn’t attended classes.

Otage Exercise Programme adverse reactions

History of intermittent knee pains past 2 years assumed osteoarthritis – no medical diagnosis. November 2011,
aches in knees. Stopped leg weights exercise. Started again January 2012 and again experienced pain in knees.
Still does other exercise tai chi and keep-fit class.

Began to have more back pain from approximately March 2011. Doing our home exercise made it worse. Saw
podiatrist then GP who diagnosed Sciatica. Given painkillers. Pain has been on and off for several years.

Burst blood vessel in leg after using Otago weights.

Hurt left wrist/fingertips after using Otago weights to strengthen arms. Ointment prescribed, wrists/
fingertips recovered.

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 APPENDIX 3

Pain in small of back after Otago training.

Plantar fasciitis – started after Otago exercises.

Potentially pulled ligament in right knee.

Patient reported in diary that they had slight hip problem; during follow-up telephone call patient stated that
‘walking backwards during home exercises’ had aggravated hip; OK now stopped exercises.

Patient withdrew from study exercises because of pains in right hip exacerbated by exercise; has sciatic pain –
intermittent and ongoing. Also commented in OEP evaluation forms of general health decline and hip and
sciatica problems.

Suspected pulled muscle in right foot after Otago training.

Swelling of varicose vein on right leg after using leg weights. Also commented on OEP evaluation forms.

While walking a lot on holiday patient hurt back, patient puts it down to a disc problem in the past and will
rest it, will not see the doctor as it is a reoccurrence and just needs rest.

Decided to cycle not walk for exercise. Went up hill and got a hernia. About to go in for operation.

Keyhole surgery on knee.

Left knee/groin pain after doing ankle exercises with weights.

Pain in leg from exercises.

Pulled knee ligaments when doing exercises with weight. Right knee, recently replaced. Saw GP about it.
No long-term damage. Is continuing without weights.

Pulled muscle in back.

Pulled muscle in leg after exercising.

Bad knees for years. Advised to see GP.

Hip pain diagnosed with arthritis, patient thinks caused by weights exercise.

Left knee pain after exercises with 2-kg weights on.

Pain behind knee – better now after stopping exercising with weights.

Pain when walking, thinks as a result of OEP training and her existing osteoarthritis.

Sciatic worsened after OEP training.

Sciatica worsened.

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Usual-care adverse reactions

Pain in shoulder while using ‘shake weight’.

Worsened pain in knees and lower back. X-ray came back fine; patient said her knees and back were starting
to feel better.

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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

Appendix 4 Secondary outcomes (from Chapter 6)

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 96
APPENDIX 4

TABLE 42 Distribution of secondary outcome measures of PA by time and intervention arm

Follow-up

Measure Baseline Post intervention 6 months post intervention 12 months post intervention 18 months post intervention

Randomisation group Randomisation group Randomisation group Randomisation group Randomisation group
Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP

NIHR Journals Library www.journalslibrary.nihr.ac.uk

CHAMPS total calories per week

Mean 2222.27 2129.06 2314.04 2662.37 2704.59 2450.67 2444.28 2459.29 2534.42 2573.63 2660.90 2787.53 2374.87 2639.04 2739.06

Median 1713.60 1690.56 1782.20 1897.68 2191.54 2029.00 1950.12 1919.41 1890.24 1829.36 2079.80 2004.08 1811.25 1979.79 2077.62
SD 2180.93 2009.50 2009.83 2620.97 2212.64 1891.44 2149.83 2180.54 2154.03 2158.80 2247.96 2771.58 2016.37 2460.90 2382.97

n 391 339 354 261 224 220 240 195 192 221 192 184 219 180 178

PASE total score

Mean 119.19 109.11 119.85 130.12 128.08 124.82 124.70 120.39 125.36 122.52 124.18 126.75 119.92 118.46 125.81

SD 60.42 52.21 50.60 53.12 51.15 51.42 56.03 59.88 54.13 51.81 53.34 61.29 52.06 52.17 60.18

n 400 342 362 264 224 224 242 195 194 222 193 185 221 181 179

Phone-FITT total score

Mean 36.80 37.68 41.18 46.56 48.32 48.39 47.87 47.93 49.01 47.71 49.52 49.38 47.87 48.59 47.95

SD 13.65 13.67 13.11 16.52 14.53 14.92 15.93 15.18 16.36 17.41 15.95 16.50 17.58 14.99 18.18

n 377 316 354 255 214 259 260 218 245 225 208 237 238 202 221
 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

3000
Total calorie expenditure

Usual care
2000
FaME
OEP

1000

0
Baseline End of intervention 6 months PI 12 months PI 18 months PI
Time post intervention (months)

FIGURE 12 Line graph to show means of total calorie expenditure by time and intervention arm.

150
Mean PASE total score

100 Usual care

FaME
OEP
50

0
Baseline End of intervention 6 months PI 12 months PI 18 months PI
Time post intervention (months)

FIGURE 13 Line graph to show means of PASE score by time and intervention arm.

50
Mean telephone FITT total score

40

Usual care
30
FaME
20 OEP

10

0
Baseline End of intervention 6 months PI 12 months PI 18 months PI
Time post intervention (months)

FIGURE 14 Line graph to show means of Phone-FITT score by time and intervention arm.

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 98
APPENDIX 4

TABLE 43 Distribution of secondary outcome measures of fear of falling (FES-I) by time and intervention arm

NIHR Journals Library www.journalslibrary.nihr.ac.uk

Follow-up

Measure Baseline 0 months 6 months 12 months 18 months

Randomisation group Randomisation group Randomisation group Randomisation group Randomisation group
Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP

FES-I total

Mean 9.36 8.99 8.89 8.71 8.59 8.77 9.06 8.85 8.83 8.94 9.20 9.09 9.01 8.76 8.97
Median 8.00 7.00 7.00 7.00 7.00 7.00 7.00 7.00 7.00 7.00 7.00 7.00 7.00 7.00 7.00

SD 4.08 3.56 3.49 3.47 3.39 3.98 3.91 3.87 4.11 3.66 4.56 4.19 3.67 3.48 3.75

n 396 333 359 258 218 221 238 192 190 220 188 185 217 177 178

Number ≥11 82 66 61 43 29 29 38 31 26 37 31 33 43 31 34

Per cent ≥11 20.71 19.82 16.99 16.67 13.30 13.12 15.97 16.15 13.68 16.82 16.49 17.84 19.82 17.51 19.10
 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

30

25
Mean FESI total score

20 Usual care
FaME
15
OEP

10

5
Baseline End of intervention 6 months PI 12 months PI 18 months PI
Time post intervention (months)

FIGURE 15 Line graph to show means of FES-I score by time and intervention arm.

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 100
APPENDIX 4

TABLE 44 Distribution of measures of quality of life by time and intervention arm

Follow-up

Measure Baseline 0 months 6 months 12 months 18 months

Randomisation group Randomisation group Randomisation group Randomisation group Randomisation group
Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP
SF-12 physical health component score

NIHR Journals Library www.journalslibrary.nihr.ac.uk

Mean 38.73 38.74 38.78 40.37 39.64 40.52 38.68 39.30 38.83 39.11 38.85 39.30 N/A N/A N/A

SD 5.50 5.65 5.64 5.02 4.75 4.64 4.88 5.01 4.79 5.00 4.92 4.73 N/A N/A N/A

n 454 386 407 298 255 261 234 184 187 217 186 183 0 0 0

SF-12 mental health component score

Mean 49.88 49.60 50.15 49.50 49.91 49.66 49.20 48.34 49.62 49.16 48.74 49.05 N/A N/A N/A

SD 6.09 6.02 5.86 5.19 5.86 4.87 5.64 6.47 5.24 5.60 5.81 5.11 N/A N/A N/A

n 454 387 407 298 255 261 234 184 187 217 186 183 0 0 0
OPQoL total score

Mean 130.75 129.36 129.36 131.36 131.48 131.89 134.21 132.68 133.45 134.80 132.31 133.72 133.75 133.60 134.53

SD 13.53 13.54 12.69 16.09 14.56 13.39 14.51 15.40 13.65 14.82 15.98 14.95 14.99 14.74 14.07

n 342 273 312 237 190 199 206 158 156 185 169 156 183 152 154

EQ-5D

Mean 0.67 0.67 0.68 0.70 0.69 0.70 0.66 0.67 0.67 0.68 0.67 0.68 N/A N/A N/A

SD 0.08 0.09 0.09 0.07 0.08 0.07 0.08 0.08 0.07 0.07 0.07 0.07 N/A N/A N/A
n 450 380 399 296 255 258 225 178 184 212 179 176 0 0 0
N/A, not applicable.
 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

(a)
Mean SF-12 Physical component score

100

80
Usual care
60
FaME
40 OEP

20

0
Baseline End of intervention 6 months PI 12 months PI 18 months PI
Time post intervention (months)
(b)
Mean SF-12 Mental component score

100

80

60 Usual care
FaME
40
OEP
20

0
Baseline End of intervention 6 months PI 12 months PI 18 months PI
Time post intervention (months)

FIGURE 16 Line graph to show means of quality-of-life measures by time and intervention arm. (a) Mean SF-12
physical component score by time and group; (b) mean SF-12 mental component score by time and group;
(c) mean OPQoL total score by time and group; and, (d) mean EQ-5D score by time and group. (continued )

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 APPENDIX 4

(c)
200
Mean OPQoL total score

150
Usual care
100 FaME
OEP
50

0
Baseline End of intervention 6 months PI 12 months PI 18 months PI
Time post intervention (months)
(d)
1.0

0.8
Mean EQ-5D score

0.6 Usual care

FaME
0.4
OEP

0.2

0.0
Baseline End of intervention 6 months PI 12 months PI 18 months PI
Time post intervention (months)

FIGURE 16 Line graph to show means of quality-of-life measures by time and intervention arm. (a) Mean SF-12
physical component score by time and group; (b) mean SF-12 mental component score by time and group;
(c) mean OPQoL total score by time and group; and, (d) mean EQ-5D score by time and group.

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 TABLE 45 Other self-efficacy outcome measures

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Follow-up

Measure Baseline 0 months 6 months 12 months 18 months

Randomisation group Randomisation group Randomisation group Randomisation group Randomisation group
DOI: 10.3310/hta18490

Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP Usual care FaME OEP

ConfBal total score

Mean 12.55 12.63 12.48 12.08 12.17 11.81 12.25 12.09 12.07 12.38 12.13 12.23 12.47 12.11 12.28

Median 11.00 10.00 11.00 10.00 10.00 10.00 10.00 10.00 10.00 10.00 10.00 10.00 11.00 10.00 11.00

SD 3.93 3.98 3.76 3.33 3.86 3.37 3.77 3.79 3.33 4.05 3.65 3.71 3.87 3.75 3.44

n 389 330 353 262 215 217 233 183 186 218 183 179 217 175 174

Number=10 188 169 172 144 127 122 125 103 95 114 97 93 104 97 85
Per cent=10 48.33 51.21 48.73 54.96 59.07 56.22 53.65 56.28 51.08 52.29 53.01 51.96 47.93 55.43 48.85

MSPSS total

Mean 65.81 65.93 66.60 67.95 65.78 65.43 65.78 63.79 65.64 67.23 63.27 63.46 66.15 65.57 65.55

Median 71.00 69.00 70.50 72.00 69.00 69.00 71.00 67.00 69.00 71.00 67.00 68.00 72.00 69.00 69.00

SD 17.96 15.57 15.49 15.68 15.05 16.97 18.21 17.37 16.74 16.54 17.69 18.14 18.04 15.68 17.58

n 375 305 330 243 202 210 224 175 181 209 183 171 211 173 166

Number=84 73 44 43 49 24 30 39 17 28 43 26 18 38 21 32
Per cent=84 19.47 14.43 13.03 20.16 11.88 14.29 17.41 9.71 15.47 20.57 14.21 10.53 18.01 12.14 19.28

LSNS total

Mean 15.93 16.47 15.44 16.23 15.91 15.84 16.98 15.91 16.04 16.41 15.68 15.43 16.76 16.18 15.61

SD 5.70 5.76 5.48 5.58 5.69 5.21 5.53 5.78 5.11 5.79 5.82 5.35 5.18 5.53 5.12

n 392 330 351 257 213 218 230 180 188 210 181 180 214 174 174

Number ≤11 84 67 88 55 46 46 36 40 39 43 44 39 37 35 37

Per cent ≤11 21.43 20.30 25.07 21.40 21.60 21.10 15.65 22.22 20.74 20.48 24.31 21.67 17.29 20.11 21.26

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HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

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103
 APPENDIX 4

(a)
Mean ConfBal total score 30

25
Usual care

20 FaME
OEP
15

10
Baseline End of intervention 6 months PI 12 months PI 18 months PI
Time post intervention (months)
(b)
Mean MSPSS total score

80

60 Usual care
FaME
40 OEP

20

Baseline End of intervention 6 months PI 12 months PI 18 months PI

Time post intervention (months)
(c)
30
Mean LSNS total score

20
Usual care
FaME
OEP
10

0
Baseline End of intervention 6 months PI 12 months PI 18 months PI
Time post intervention (months)

FIGURE 17 Line graphs of other measures. (a) Mean ConfBal total score by time and group; (b) mean MSPSS total
score by time and group; and, (c) mean LSNS total score by time and group.

104
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 DOI: 10.3310/hta18490 HEALTH TECHNOLOGY ASSESSMENT 2014 VOL. 18 NO. 49

TABLE 46 Distribution of measures taken only at baseline and post intervention by time and intervention arm

Baseline 0 months

Measure Randomisation group Randomisation group

Usual care FaME OEP Usual care FaME OEP

FRAT total score

Mean 1.03 0.89 0.98 0.99 0.93 1.00

SD 0.96 0.90 0.90 0.90 0.94 0.95

n 453 383 402 299 253 263

Number ≥1 298 232 264 196 157 170

Per cent ≥1 65.78 60.57 65.67 65.55 62.06 64.64

OEE positive

Mean 3.84 3.85 3.85 3.85 4.02 3.93

SD 0.58 0.62 0.60 0.64 0.55 0.65

n 372 309 349 252 206 211

OEE negative

Mean 3.85 3.96 3.90 3.96 4.19 4.20

SD 0.81 0.75 0.85 0.87 0.75 0.71

n 367 320 339 248 204 203

Functional reach (cm)

Mean 24.68 25.60 25.57 27.13 26.99 26.84

SD 7.43 6.98 7.43 6.82 7.28 7.64

n 438 371 402 293 249 232

Sits to stands (total)

Mean 10.49 10.48 10.26 11.86 11.62 11.40

SD 3.31 3.64 2.81 3.57 3.77 3.35

n 449 377 400 285 252 245

TUG (seconds)

Mean 11.11 10.95 11.18 10.24 9.94 10.09

Median 9.88 9.63 9.84 9.30 9.00 9.30

SD 4.61 4.94 7.84 4.02 3.75 3.97

n 438 337 376 273 203 203

Log-TUG (seconds)

Mean 2.35 2.33 2.33 2.28 2.25 2.27

SD 0.32 0.34 0.34 0.27 0.30 0.27

n 438 337 376 273 203 203

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This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that
suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR
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