Diabetic Foot Ulcer Beyond Wound Closure: Clinical Practice Guideline

Running Head: DFU Beyond Wound Closure

Article Type: Clinical Practice Guidelines

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TOC Category: Diabetes
Submitted Date: December 13, 2023

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Revised Date: June 28, 2024
Accepted Date: July 30, 2024

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Authors/Affiliations:

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Deborah M. Wendland, PT, DPT, PhD1; Elizabeth A. Altenburger, PT, MSPT, Certified Wound Specialist2;

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Shelley B. Swen, PT, DPT, Certified Wound Specialist, Certified Lymphedema Therapist-Lymphology
Association of North America3; Jaimee D. Haan, PT, MBA, Certified Wound Specialist4
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1
Department of Physical Therapy, Mercer University, Atlanta, Georgia, USA
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2
Rehabilitation Services, AHC and Saxony, Indiana University Health, Indianapolis, Indiana, USA
3
Desert Oasis Healthcare, Palm Springs, California, USA
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4
Rehabilitation, Wound Management and Fitness, Academic Health Center, Indiana University Health,
Indianapolis, Indiana, USA
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Address all correspondence to Dr Wendland at: wendland_dm@mercer.edu.

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The Author(s) 2024. Published by Oxford University Press on behalf of the American Physical
Therapy Association.
Abstract

A total of 37.3 million Americans have diabetes, and 96 million more have prediabetes. Hyperglycemia,
the hallmark of diabetes, increases the risk for diabetes-related complications, including skin breakdown
and cardiovascular disease. Many clinical practice guidelines exist, but there are gaps regarding the best
approaches to assess physical fitness and mobility in adults with diabetes; incorporate exercise into the
care plan; and reload the diabetic foot after ulcer closure has occurred to avoid ulcer reoccurrence. The

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purpose of this clinical practice guideline was to review and assess previously published guidelines and
address gaps within the guidelines specific to the following: best screening tools/tests and interventions
to prevent a future reulceration, best screening tools and interventions to assess and address mobility

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impairments, best tools to measure and interventions to address reduced physical fitness and activity,
best approach to reloading the foot after ulceration closure and, finally, whether improvement in

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physical fitness will positively change quality of life and health care costs. The Guidelines Development
Group performed a systematic literature search and review of the literature. A total of 701 studies were
identified. Following duplicate removal and exclusion for irrelevance, 125 studies underwent full-text

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review and 38 studies were included. Recommendations were developed using a software assistant
created specifically for guideline recommendation development. Recommendations resulted for

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physical fitness and activity inclusion and measurement for adults with diabetes and with or without
foot ulceration. Exercise and physical activity should be prescribed according to the physiologic response
of an adult with diabetes to exercise and preferences for optimizing long-term quality of life and reduce
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health care costs. Reloading following diabetic foot ulcer closure should include maximal offloading,
especially during the first 3 months; loading should be titrated using a footwear schedule. Further
research is necessary in the areas of exercise in the wound healing process and the assessment of
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methods to reload a newly reepithelialized ulcer to prevent recurrence.
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Lay Summary. This Clinical Practice Guideline recommends that physical fitness and activity are included
and measured for adults who have diabetes with and without foot ulceration. Exercise and physical
activity should be prescribed according to the individual's current condition, physiologic response to
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exercise, and preference to optimize long-term quality of life and reduce health care costs.

Keywords: Clinical Guidelines, Diabetes Mellitus, Diabetic Foot

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© The Author(s) 2025. Published by Oxford University Press on behalf of the American Physical Therapy
Association.
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This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-
Commercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial
re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For
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commercial re-use, please contact journals.permissions@oup.com

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[H1]Introduction

Diabetes continues to cause significant mortality and debility worldwide. In 2019, diabetes was the
seventh leading cause of death and a major contributor to the world’s leading cause of death,
cardiovascular disease. The National Diabetes Statistics Report of the Centers for Disease Control and
Prevention states that 37.3 million Americans have diabetes and another 96 million people have

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prediabetes.1

Hyperglycemia, a hallmark of diabetes, puts people at an elevated risk for diabetes-related

complications. Included among complications of diabetes are vascular (micro and macro) changes as

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well as changes to the nervous system. Together, these changes increase the risk for plantar ulceration
in people with diabetes. As many as 34% of people with diabetes experience plantar ulceration over

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their lifetimes.2 Furthermore, those who have diabetic foot ulcerations that heal are at high risk for
reulceration. Risk is highest immediately following wound closure, with 40% reulcerating within 12
months. Over 3 years, nearly 60% of people experience reulceration.2

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Given the prevalence of diabetes and the impact of the disease on morbidity, health care providers must

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understand and have guidance on the most effective means of preventing and limiting the long-term
comorbidities related to diabetes.3,4 In reviewing the major causes of hospitalizations for people with
diabetes, the second most common discharge diagnosis after hospitalization is lower extremity
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amputation, which usually is preceded by a diabetic foot ulcer (DFU).5 Although numerous clinical
practice guidelines (CPGs) exist for healing a DFU, there are gaps regarding how to best assess physical
fitness and mobility in adults with diabetes and with or without a DFU; incorporate exercise into the
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care plan to effectively aid in the control of glycemia, either in preventing an ulcer or while managing an
ulcer; and reload the diabetic foot after ulcer closure to avoid ulcer reoccurrence.6–10
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In the Standards of Care in Diabetes—2023, physical activity recommendations were given as part of the
overall diabetes prevention recommendations.3 These recommendations listed physical activity as a
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component of obesity and weight management for the prevention and treatment of type 2 diabetes but
did not specifically discuss how to incorporate physical activity into a plan of care for an adult with an
ulcer or how to return to physical activity after ulcer closure.3 These guidelines also did not discuss
assessing overall mobility as an adult with diabetes ages.4 Similarly, other guidelines regarding diabetes
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care for adults with a DFU, at risk for a DFU, or with a history of a DFU do not sufficiently address or
provide tools for the management of fitness in patients with diabetes and skin concerns.6–8 What is not
known is whether individual studies, reviews, or meta-analyses have tested or evaluated the answers to
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these important clinical questions, particularly in the context of a healing or closed DFU.

The purpose of this review was to assess previously published guidelines and address gaps within the
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guidelines specific to the following: best screening tools/tests and interventions to prevent an initial DFU
or future reulceration, best screening tools and interventions to assess and address mobility
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impairments, best tools to measure and interventions to address reduced physical fitness and activity,
best approach to reloading the foot after ulceration closure and, finally, whether improvement in
physical fitness will positively change quality of life and health care costs. The authors believe that
management of the DFU itself for healing has been appropriately addressed in earlier CPGs. The CPG
action statements resulting from this review is shown in Table 1.
[H1]Methods

[H2]Guideline Development Group

The American Physical Therapy Association (APTA) Academy of Clinical Electrophysiology and Wound
Management (ACEWM) commissioned the development of an evidence-based CPG to address the

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paucity of information regarding people with a DFU related to areas that physical therapists address.
Members of the ACEWM attended the CPG Workshop and began the process of developing a Guideline
Development Group (GDG). Initially there were 2 physical therapists who were Certified Wound

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Specialists (E.A.A.) and another physical therapist in an academic position with a research agenda
related to DFUs (D.M.W.). An additional physical therapist who was a Certified Wound Specialist and

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who had attended the CPG Workshop the previous year (J.D.H.) was also included in the initial group. To
add breadth to the team, another physical therapist academician with expertise in ankle-foot
management was added. Over the course of working on this document, 2 of the physical therapist

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members retired, 1 of whom agreed to continue as a consultant member. After the first member of the
GDG retired, a new physical therapist who was a Certified Wound Specialist was added to the group

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(S.B.S.).

[H2]Review Team
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At the time of the CPG Workshop, a number of stakeholders were identified to serve as members of the
external review team. These members were included to add depth and breadth of expertise and
included a patient, physician, podiatrist, physical therapist clinicians from other specialization areas as
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well as those with expertise in the field of DFU care. Some specific members of this group changed due
to availability, but the general group make-up remained.
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[H2]CPG Review: The ADAPTE Process

Following review of CPGs related to the management of DFUs and published up to the year 2015 (Suppl.
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Mat. 1), research questions were developed to address gaps in guidance within the existing CPGs.
Research questions were determined following review of current practice guidelines. The intent of this
CPG was to adapt current guidelines to assist in clinical practice decision-making surrounding the care of
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people with diabetes and foot ulceration that was not presently being addressed by any previously
published CPG. The ADAPTE process uses the Appraisal of Guidelines for Research & Evaluation II
(AGREE II) tool, which is an international tool designed to assess the quality of CPGs. Assessment is
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performed in 6 domains (scope and purpose; stakeholder involvement; rigor of development; clarity of
presentation; applicability; and editorial independence) using a 7-point numerical scale, with 7 being the
highest score.11 When possible, feedback was addressed. Using the AGREE II tool, National Institute for
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Health and Care Excellence8 and Registered Nurses’ Association of Ontario9 CPGs were determined to
sufficiently guide wound management concerns in people with diabetes and foot ulceration and were
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accepted for the ADAPTE process. In 2017, the following questions were developed to facilitate
additional clinical decision-making guidance in areas that were insufficiently addressed.

1. In an adult with diabetes, what are the best screenings/tests and measures to prevent initial
foot ulceration?
2. In an adult with diabetes, what are the best interventions to prevent initial foot ulceration?
 3. What are the best interventions to reduce the risk of future ulcerations?
4. In an adult with diabetes, what are the best test/measures to assess mobility impairments?
5. In an adult with a current diabetic foot ulcer, what are the best interventions to address mobility
impairments?
6. Across the continuum of care of an adult with diabetes, what are the best tests and measures to
assess physical fitness and activity?
7. Across the continuum of care of an adult with diabetes, what are the best interventions to

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address reduced physical fitness and activity?
8. What are the best methods to progressively load tissue after ulceration closure to prevent
recurrence in adults with diabetes?

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9. In an adult with diabetes, do physical fitness and activity optimize long-term quality of life as
well as reduce health care costs?

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[H2]Literature Search Strategy

In consultation with a medical librarian at Indiana University Health, search terms and a search strategy

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were identified to address each of these research questions. The following databases were searched

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according to the preestablished search terms (Suppl. Mat. 2): PubMed (MEDLINE) and Cumulative Index
to Nursing and Allied Health Literature (CINAHL). The search dates were inclusive from “1946 until
present” when the searches were undertaken. Articles were restricted to human studies and English
language only. References were reviewed for potential additional articles. The searches were initially
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carried out in January 2018. Over the time required during the first review process for this CPG, updates
to other DFU-related CPGs were published.
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In 2019, the International Working Group on the Diabetic Foot (IWGDF)6 published their CPG update,
which the GDG reviewed using the AGREE II tool. The GDG determined that questions 1 to 3, which
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were specific to the prevention of an initial ulcer or reulceration, were sufficiently addressed by the
updated IWGDF CPG. These questions were then removed from this work as the IWGDF guidance for
this area was accepted as put forth within their 2019 guideline (ADAPTE process). After the literature
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review for question 4 found no research specifically addressing assessment of mobility impairments for
adults with diabetes, the GDG reviewed the CPG developed through the Academy of Neurological
Physical Therapists to guide outcome measure selection for people with neurologic conditions.12 The
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GDG decided to move this CPG into the ADAPTE process and used the AGREE II tool. The GDG
determined that the CPG adequately guided the assessment of mobility impairments for people with
diabetes, who often have neurologic involvement affecting their function. Thus, question 4 was also
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removed. The searches were rerun in March/April 2022 and again in February 2023 for the remaining
questions (5–9) (Tab. 2) to locate any additional literature published since the last search. Only data
from questions 5 to 9 will be reported in this CPG.
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Studies to be included from the literature search were experimental, randomized controlled trials
(RCTs), systematic reviews, meta-analyses, and diagnostic or prognostic retrospective studies. Reviews
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that were nonsystematic, descriptive studies, case reports, and nonscientific papers were excluded. The
population was limited to adults with diabetes, but the type of diabetes was not specified (Tab. 3).

[H2]Literature Review and Extraction

Covidence software (Veritas Health Innovation; www.covidence.org) was used for all of the literature
reviews. Literature search results were imported into Covidence software, which removed study
duplicates. Then, the titles and abstracts were independently reviewed by 2 reviewers using inclusion
and exclusion criteria (Tab. 3). If the determination of the reviewers was conflicting, then the reviewers
came to consensus through discussion. If consensus could not be achieved, then “maybe” was selected.
Both “yes” and “maybe” studies were moved forward in Covidence for full article review. Full-text
reviews were completed by 2 independent reviewers for inclusion or exclusion. If exclusion was chosen,

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then the reason for exclusion was given. Any disagreements between reviewers, including reasons for
exclusion, were discussed so that consensus could be achieved. Once an article was included, the studies
were reviewed for risk of bias (quality appraisal) as well as for extraction of data. Studies were reviewed

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by 2 reviewers, and consensus on outcome was achieved through discussion. If consensus could not be
achieved, then a third reviewer, a member of the GDG who served as the question champion, served as

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the tiebreaker. Data extraction was completed by the person serving as the tiebreaker. The accuracy of
extraction was checked by the other reviewers.

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[H2]Quality Appraisal

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Quality appraisal was completed consistent with the APTA Clinical Practice Guideline Process Manual,13
except that the Physiotherapy Evidence Database was used to assess interventional studies, namely,
RCTs.14 Systematic reviews were assessed using A Measurement Tool to Assess Systematic Reviews,15
diagnosis studies and cohort studies were assessed using a Scottish Intercollegiate Guidelines Network
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checklist,16 studies of measurement tools were assessed using the Consensus-Based Standards for the
Selection of Health Measurement Instruments (COSMIN),17 and prognosis studies were assessed using
the Best Bets tool.18
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Article appraisal was undertaken by members of the GDG team. Additional reviewers were trained to
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use the Physiotherapy Evidence Database appraisal measure. Once training was completed and
reviewers were consistent in their reviews, they were assigned interventional studies to review in pairs.
All reviews were completed in duplicate such that consensus was achieved as described above.
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Each article was given a level of evidence, and the body of literature reviewed for each question was
graded in a manner consistent with the APTA Clinical Practice Guideline Process Manual.13 Brief
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summaries of the meanings of levels of evidence and the grading of evidence are shown in Tables 4 and
5, respectively.

[H2]Data Analysis
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The original literature search was completed in March 2018, and repeat searches to ensure inclusivity of
all studies were completed in March 2022 and again in February 2023. Articles were imported into
Covidence software according to each question. Covidence software removed any duplication of
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literature within each question. Additional studies were removed because they were irrelevant through
review of the title and abstract. The remaining studies underwent full-text review for inclusion. During
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the review process, IWGDF published new guidelines that included information answering questions 1
to 3.6 Question 4 was answered by a new guideline published by the Academy of Neurological Physical
Therapists.12 These questions were moved out of the guideline since the ADAPTE model was being used
(Tab. 6, which combined the content of the Preferred Reporting Items for Systematic Reviews and Meta-
Analyses [PRISMA]+ diagrams).
[H2]Development of Action Statements

Action statements were developed using BRIDGE-Wiz (Building Recommendations in a Developer’s

Guideline Editor) software; this software was developed to aid in the authoring of unambiguous and
actionable guidelines.19 The CPG development team worked through the process as a group following
completion of article quality appraisal and extraction. Findings will follow with the action statement

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recommendations listed first, according to each question.

[H2]External Review Process

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The external review process was consistent with that described by the APTA Clinical Practice Guideline
Process Manual.13 The process was designed to facilitate a comprehensive, quality report while

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mitigating risk for bias or lapses in process. At the outset of the project, stakeholders were identified;
they included a patient, representatives from medicine and podiatry, physical therapists from other

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specialization areas, and experts in DFU management (defined as people who have published in this
area of practice). Additionally, methods experts were consulted. The draft document was sent to a

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group representing the above stakeholders for review, editing, and open comment. The feedback was
taken and incorporated into the draft. The document was externally reviewed by representatives from
the ACEWM, a CPG methodology expert, and association partners. The feedback from this body and any
other delayed feedback were addressed, and the subsequent document was posted on the ACEWM
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website for public comment and review. Invitations for the public comment/review of the document
were included in the ACEWM monthly newsletter, eblasts, and social media. Both ACEWM members and
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nonmembers were able to review and provide feedback. Suggested feedback and edits were considered
and incorporated as appropriate. The document was submitted to PTJ: Physical Therapy & Rehabilitation
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Journal for editorial review concurrently to the secondary reviews and public feedback process.
Comments were addressed.
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[H2]Role of the Funding Source:

The American Physical Therapy Association (APTA) provided funding to support the development of this
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CPG. In addition, APTA’s CPG Process Manual was used to guide its development. The views expressed
do not necessarily reflect the official views of APTA.
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[H1] Action Statements

[H1]Question 5
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In an adult with a current diabetic foot ulcer, what are the best interventions to address mobility
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impairments?

[H2]Recommendation I

Physical therapists and other health care providers who prescribe exercise for adults with a DFU may
prescribe interventions to maintain cardiovascular health and muscular fitness while minimizing weight
bearing on the foot. In addition, an assistive device may be used as needed to improve balance and
further reduce weight bearing in an adult with a current DFU (evidence quality: D; recommendation
strength: weak).

[H3]Aggregate evidence quality

This is rated as D level or theoretical evidence (Tab. 5). Two systematic reviews and 1 scoping review
that addressed a broader physical activity in adults with a DFU rather than explicitly mobility

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impairments were included. The evidence within these reviews was thus described as theoretical.

[H3]Benefits

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Prescribed exercise may preserve functional capacity, minimize trauma, improve wound healing, and
reduce risk of falls.

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[H3]Risk, harm, and cost

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There are potential costs related to the cost of the assistive device, overall wound treatment, and any
lost income due to participating in an exercise program.

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[H3]Benefit-harm assessment

There is a preponderance of benefit. M

[H3]Value judgments

The guiding principle behind the question development was to help health care providers optimize the
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physical fitness and activity of adults with a current DFU without harming the wound healing process.
This is not widely considered a priority in adults with these medically complex issues, but we
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recommend that physical therapists and other health care providers who prescribe exercise consider
developing exercise programs for this population as the long-term impact on cardiovascular health and
muscular fitness is a significant benefit.
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[H3]Intentional vagueness

The developers were intentionally vague about which interventions to use due to the lack of evidence
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supporting specific interventions. Three systematic reviews published between 2000 and 2023 assessed
research of therapeutic exercise for adults with a DFU. All 3 systematic reviews found that there is a
need for well-conducted RCTs to guide specifically which interventions are best to improve the
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cardiovascular health and muscular fitness of these adults without harming the healing response of the
DFU.20–22 In addition, the developers expect that clinicians will select interventions that address each
individual person’s needs and goals. Supplementary Material 3 shows an example for how fitness could
be improved or maintained while in the period of offloading.
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[H3]Role of patient preferences

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Although the spectrum of exercise intervention is limited due to the need to minimize weight-bearing on
the foot, exercise program prescription still should incorporate an adult’s preferences to increase
adherence and therefore optimize outcomes.23

[H3]Exclusions
Modifications should be made for any adult with disease conditions that contraindicate a specific
exercise intensity. Further, exercise should be performed only by adults within safe glycemic ranges.
Colberg et al24 provide detailed guidance on the management of glycemia with exercise.

[H3]Implementation and audit

Clinicians may consider incorporating exercise prescriptions into the electronic medical record (EMR) as
part of the complete plan of care for patients. Using scripted phrases or drop-down menu choices may

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increase implementation and improve standardization to allow for better auditing of outcomes. Finally,
an annual audit of clinician inclusion of exercise prescription in the care plan for an adult with a DFU

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would reinforce implementation.

[H3]Research recommendation

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Research is needed to determine the most effective interventions to use while prescribing exercise for
adults with a DFU. Although there is broad agreement that adults with diabetes benefit from exercise,

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there is little guidance on which interventions will provide that benefit while protecting the foot ulcer.

[H3]Supporting evidence and clinical interpretation

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In 2022, Brousseau et al20 published a scoping review to determine the impact of physical activity on
adults with a DFU. Although they identified 19 articles from 17 studies, they were unable to make
specific recommendations due to the lack of research, especially RCTs, with strong methodology. They
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specifically called for high-level RCTs focused on physical activity prescription as there is no evidence to
guide the components of physical activity. In 2022, Aagaard et al21 made similar recommendations in
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their systematic review that specifically looked for the impact that exercise has on health-related quality
of life (HRQOL) compared to the risk of harm that exercise may have on the DFU. Although there were
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10 research articles related to exercise for adults with a DFU, none reported the impact on HRQOL and
the methodology did not allow for reliable conclusions related to exercise and harm. Finally, the
systematic review of Wendland et al22 investigated the evidence of whether to determine if exercise,
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physical activity, walking step characteristics, or limb loading affects healing outcomes in people with a
DFU. Secondarily, they looked at whether the quantity of exercise, stepping activities, or limb loading
affect the length of time to wound closure in people with a DFU. Because of large variation in step
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activity and group metrics, it was determined that no specific exercise recommendations could be made,
although exercise appeared to facilitate more rapid DFU healing. All 3 of these articles made consistent
recommendations for more research on the effect of exercise on wound healing.
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[H1]Question 6
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Across the continuum of care of an adult with diabetes, what are the best tests and measures to assess
physical fitness and activity?
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[H2]Recommendation II
Physical therapists and other health care providers who evaluate physical fitness in adults with
diabetes should measure physical fitness, including flexibility, strength, cardiorespiratory fitness,
balance, and motor agility (evidence quality: C; recommendation strength: weak), AND may measure
the level of physical activity, such as step counting and standing, across the continuum of care of an
adult with diabetes (evidence quality: D; recommendation strength: weak).
[H3]Aggregate evidence quality
There was a single, level II article assessing the psychometric properties of tests of physical fitness,
including physical function.25 This article lacked blinding and had <80% follow-up among the
participants. This is rated as C level or weak evidence.

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Measuring the level of physical activity has been suggested by published expert opinion as being helpful
in increasing physical activity. This is rated as D level or theoretical evidence.26

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[H3]Benefits

Measuring the physical fitness of a patient may facilitate the identification of a change in fitness that can

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affect functional ability and diabetes management. Early identification of decreased physical fitness
provides a benefit to the patient and provider.

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Measuring the physical activity of a patient may facilitate the identification of changes in activity that
may indicate progression of the disease, new risk for falls, ulcerations, or functional decline.

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[H3]Risk, harm, and cost

No adverse events were reported in the study of Alfonso-Rosa et al.25 When assessing various
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components of physical fitness, there is a risk that an individual could experience a fall or injury during
testing. This risk is mitigated by careful training and the inclusion of safety behaviors learned as a part of
physical therapist education.
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The cost to the individuals who undergo testing is primarily their time and effort to be tested, including
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transport to the facilities for testing. If activity monitoring is employed, cost is in the device itself and
potential risk for skin issues from the device, depending on the device used.

[H3]Benefit-harm assessment
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There is a preponderance of benefit.

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[H3]Value judgments

Monitoring physical fitness in adults with diabetes as they age will positively affect the quality of
their health. Using consistent physical fitness testing tools that have been psychometrically tested
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for a population with type 2 diabetes, particularly those with minimal detectable change (MDC)
values, is helpful to recognize fitness change in this population. We recommend that standardized
protocols be used to support the reliability of these tests across time and individual patient care
episodes (Tab. 7).
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[H3]Intentional vagueness
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The recommendation of who should evaluate the physical fitness of this population was
intentionally vague to allow for inclusivity of all qualified health care providers. The type of fitness
testing and activity monitoring within the recommendation was intentionally vague due to limited
research to guide more specific recommendations. The studied tests are included in the supporting
evidence and in Table 7 to provide some direction for clinicians.
[H3]Exclusions

Clinicians should use their clinical judgment when selecting tests and outcome measures. Certain
tests should not be performed if contraindicated by the person’s disease state. Care should be
taken in cases in which balance is compromised. Tests should not be performed if contraindicated
(eg, ambulatory test in the presence of a plantar DFU).

[H3]Implementation and audit

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Clinicians and facilities should establish competencies of physical fitness tests, including tests of
physical function, before performing them with their patients with diabetes. Alfonso-Rosa RM et

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al25 provide specific tests descriptions. Annual training and practice could help facilitate excellent
reliability with the performance of acceptable tests, including the handgrip strength test, chair sit
and reach test (CSRT), the Timed “Up & Go” (TUG) Test, the 6-minute walk test (6MWT), and the

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30-second sit-to-stand (30STS) test. Clinicians may also consider incorporating exercise
prescriptions into the EMR as part of the complete plan of care for patients. Using scripted phrases
or drop-down menu choices may increase implementation and improve standardization to allow

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for better auditing of outcomes. Finally, an annual audit of clinician use of performance testing

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would reinforce implementation.

[H3]Supporting evidence and clinical interpretation

Selecting outcome measures with established psychometric properties is helpful to determine when
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actual change has occurred and whether that change is clinically relevant. Some tests which assess
physical fitness, including physical function, have been assessed for psychometric properties in people
with type 2 diabetes. Included among these tests are the handgrip strength test, the CSRT, the TUG Test,
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the 6MWT, and the 30STS test.25 A high ICC as a measure of relative reliability using a test-retest design
were found for all the tests assessed. Additionally, MDC scores were determined for each of the tests as
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well. Table 7 shows specific psychometric properties.25

The handgrip strength test can be used, with excellent relative reliability, to assess upper extremity
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strength on both the dominant and nondominant sides. MDCs of 3.85 kg (dominant upper extremity),
4.32 kg (nondominant upper extremity), and 4.13 kg for bimanual testing were noted. The hand grip
strength test is feasible because it requires commonly available equipment (handheld dynamometer) in
clinical settings. The time required to administer the test is <5 minutes, including the minute of rest
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required between measures.25

The CSRT can be useful to test lower extremity flexibility with excellent reliability for both sides. The
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MDCs were 7.50 cm for the right side and 9.01 cm for the left side. This test is clinically feasible since it
only requires a ruler and a chair for the individual to sit in. It takes <5 minutes to administer.25

The TUG Test can be used to assess motor agility and general mobility (physical fitness and physical
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function) and has excellent relative reliability and an MDC of 0.85 second. These values, along with the
short testing time (<5 minutes) and minimal required equipment, make this test clinically feasible.25
U

The 6MWT can be used to assess the cardiovascular fitness of an individual. In individuals with type 2
diabetes, the test was shown to have excellent relative reliability and an MDC of 27.37 m. The 6MWT is
feasible to assess cardiovascular fitness. It requires only a stopwatch and a hallway, both consistently
available in clinics. This test takes <10 minutes to perform.25
The 30STS test can be used to assess the strength of the lower extremities. The relative reliability of the
test has been shown to be excellent. Furthermore, the MDC was found to be 3.35 repetitions. This test
was feasible for its limited requirements, including short time frame. Additionally, unlike other similar
tests, the completion of any repetitions will provide useful information.25

A perspective paper addressing physical training and activity in people with diabetes and peripheral
neuropathy suggests that baseline activity levels, from which to increase activity, may be quantified
using an activity monitor.26 Additionally, a meta-analysis has shown the use of activity monitors to be

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helpful in promoting physical activity.27

[H3]Related outcome measures

RI
There is a difference of opinion on which outcome measure to use for assessment. Other outcome
measures have been used clinically to assess physical fitness; these include submaximal and

SC
maximal exercise testing (eg, treadmill tests, cycle tests),28–32 strength tests (eg, 1-repetition
maximum, strength dynamometry),33 walking tests of various durations (eg, 10-m shuttle),34 and
other sit-to-stand tests (eg, 10 times sit-to-stand or 5 times sit-to-stand).35 These tests do not have

U
available psychometric properties for a population with type 2 diabetes, including MDC scores.

AN
These tests may be more feasible depending on the patient’s fitness level (eg, a 2-minute walk test
rather than a 6MWT for someone who is deconditioned).

[H3]Research recommendation M
Studies are needed to assess the psychometric properties of other physical fitness–related
outcome measures, such as the 5 times sit-to-stand, in a population with diabetes (including both
type 1 and type 2 diabetes). Further study on the psychometric properties of the tests included
D
within the study (handgrip strength test, CSRT, TUG Test, 6MWT, and 30STS test) should be
undertaken to include a population that is more generalizable to the population of interest.
TE

Studies are needed to assess specific activity monitors for their feasibility, reliability, and accuracy for
assessing physical fitness and activity in a population with diabetes.
EC

[H1]Question 7
RR

Across the continuum of care of an adult with diabetes, what are the best interventions to address
reduced physical fitness and activity?

[H2]Recommendation IIIa
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Physical therapists and other health care providers who prescribe exercise should prescribe a
progressive moderate- to vigorous-intensity exercise program including aerobic and resistance training
to adults with diabetes after considering the patient's disease state and limits for exercise AND
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depending on the patient's physiologic response to exercise in accordance with the patient's preference
and resources (evidence quality: A; recommendation strength: strong).
U

[H2]Recommendation IIIb
Physical therapists and other health care providers who prescribe exercise may use activity monitor–
based counseling to increase physical activity (evidence quality: B; recommendation strength:
moderate).
[H3]Aggregate evidence quality
Evidence for Recommendation IIIa included reports from 16 different RCTs28,29,31,33,34,36–48 and 3 meta-
analyses.32,49,50 An additional 6 studies were interventional.30,51–55 Because of the meta-analyses and
RCTs, level I and II evidence predominated. This is rated as A level or strong evidence and risk of bias
information can be found in Table 8. Evidence supporting Recommendation IIIb was a single meta-
analysis that included 21 studies reporting activity monitor–based counseling in people with type 2
diabetes.27 Because of the lower quality of studies included within this meta-analysis, the evidence

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quality is rated as B or moderate evidence.
[H3]Benefits

RI
The benefit of including exercise, both aerobic and resistance training, to people who have diabetes, is
improved cardiorespiratory fitness and strength. Using activity monitor–based counseling may also be

SC
effective for increasing physical activity.27
[H3]Risk, harm, and cost

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The risks associated with moderate- to vigorous-intensity exercise, including both aerobic and resistance
training, are typical of exercise for everyone and include overuse injury, fatigue, and death. In addition

AN
to the typical exercise risks, hypoglycemic episodes also pose a risk for people with diabetes.3 There may
also be an increased risk for falls in the presence of peripheral neuropathy.56
[H3]Benefit-harm assessment M
There is a preponderance of benefit.
[H3]Value judgments
D
The guiding principle behind question development was to help health care providers optimize the
physical fitness and activity of adults with diabetes. We recommend that physical therapists and other
TE

health care providers who prescribe exercise consistently develop exercise programs for this population
because the long-term impact on cardiovascular health and muscular fitness is a significant benefit.
[H3]Intentional vagueness
EC

The specific type of exercise was intentionally left vague because the best exercise for an individual is
the exercise that the individual will complete. The literature support for exercise included various
interventions ranging from walking to dancing to yoga to sport to resistance training along with various
RR

intensities.32,46,49,50,53,55 While not discussed in the included articles, previous studies report that
improved self-efficacy and behavioral control likely increase exercise adherence.23
[H3]Role of patient preferences
CO

Exercise intervention should incorporate the preferences of adults with diabetes to increase adherence,
therefore optimizing outcomes.23
N

[H3]Exclusions
Modifications should be made for any adult with diabetes and disease conditions that contraindicate a
U

specific exercise intensity. Furthermore, exercise should be performed only by adults within safe
glycemic ranges.3
[H3]Implementation and audit
Clinics and facilities should establish consistent inclusion of exercise prescription with their patients with
type 2 diabetes. Annual training could facilitate the incorporation of a variety of exercises within an
exercise prescription. Annual training could also include review of glucose monitoring with exercise to
mitigate risk of exercise-related hypoglycemia.24 Public health approaches to encourage walking or
other similar exercises may also be successful. Inclusion of ticklers within the EMR may promote
consistent exercise prescription to facilitate improved physical fitness and activity. Annual audit of
follow-through may also serve to promote adoption of consistent exercise prescription among patients

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with diabetes.
[H3]Supporting evidence and clinical interpretation Studies have assessed the effects of a variety of
different activities, including aerobic activity alone,29,31,33,37,39–42 resistance (strength) activity

RI
alone,29,33,40–42 aerobic activity combined with resistance (strength) training,40–42 and sport (eg, soccer,
dance), on physical fitness.28,30,53 All types of exercise resulted in improvement in physical fitness and

SC
activity. Combined exercise patterns improved activity consistent with the approach taken. High-
intensity interval training was especially helpful compared to continuous walking.31,52 Supplementary
Material 4 shows findings. The selection of activity should also be considered in the context of an

U
individual’s overall health and ability to tolerate activity.4,24 It is important to consider the response to
exercise in the presence of diabetes when prescribing and supervising exercise.3,4,24 Exercise and sport

AN
are not the only way to promote fitness and physical activity. A meta-analysis assessed the effect of
activity monitor–based counseling in people with type 2 diabetes on physical activity compared to a
control. With 8 pooled studies, an activity monitor–based counseling intervention was favored for
increasing step count (physical activity) compared to a control without the intervention.27
M
Consideration for musculoskeletal comorbidities is important because orthopedic comorbidities and
complications can affect response to loading and exercise. Thus, it is advisable to gradually increase the
D
intensity of training. The American College of Sports Medicine could be used as a guide for the
appropriate progression of exercise.57
TE

[H3]Research recommendation
Studies are needed to assess what are the best interventions to address physical fitness and activity in
people with type 1 diabetes. Further investigation may be helpful to develop guidelines for intensity and
EC

timing of exercise to best address physical fitness and activity in all adults with diabetes.
RR

[H1]Question 8

What are the best methods to progressively load tissue after ulceration closure to prevent recurrence in
CO

adults with diabetes?

[H2]Recommendation IV

Physical therapists and other health care providers managing closed DFUs may titrate tissue reloading
N

(eg, standing, walking) on a newly closed DFU, maintaining moderate to maximal offloading, especially
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during the first 3 months, while slowly titrating a return to shoe wear using a wear schedule (evidence
quality: D; recommendation strength: weak).

[H3]Aggregate evidence quality

This is rated as D level or theoretical evidence based on expert opinion.

[H3]Benefits

Progressively reloading tissue after ulceration closure may reduce an individual’s risk of reulceration,
allow scar tissue to mature, and lower the potential costs of reulceration to the larger health care
system.

[H3]Risk, harm, and cost

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The cost of progressively reloading tissue after ulceration closure includes the physical burden to the
individual of remaining offloaded, the cost of appropriate diabetic footwear, the financial burden if the
individual is unable to resume work roles, and the financial cost to the larger health care system for the

RI
prolonged treatment of the individual.

[H3]Benefit-harm assessment

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There is a preponderance of benefit.

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[H3]Value judgments

The guiding principle behind the question development was to assist health care providers in protecting

AN
the newly closed wound tissue while transitioning the individual into their diabetic shoes, returning to
full function, and avoiding reulceration.

[H3]Intentional vagueness
M
The developers were intentionally vague about the exact steps to the transition to reloading as there is a
paucity of evidence to support a specific approach.
D

[H3]Role of patient preferences

TE

To prevent reulceration, reloading may be prioritized over patient preference. As a result, patient
education promoting adherence is critical.
EC

[H3]Exclusions

Patients who do not ambulate will not require reloading.

RR

[H3]Implementation and audit

Clinicians may consider adding a reloading schedule to their plan of care after closure of the DFU and
CO

include scripted phrases or drop-down menu options in the EMR to increase implementation and
standardization for better outcomes. Finally, an annual audit of clinician use of a reloading plan would
serve to reinforce implementation.
N

[H3]Differences of opinion

Clinicians may have differences of opinion in the time line and extent of reloading as well as devices
U

used.

[H3]Supporting evidence and clinical interpretation

For this question, the supporting evidence included expert opinion but no research studies. There were
3 articles which described the expert recommended process for reloading the diabetic foot after
ulceration closure.58–60 The postclosure protection time line given in each article varied: 3 to 4 weeks,58 1
to 3 months,59 and no specific time line.60

[H3]Research recommendation

There is a need for observational and prospective studies that assess postclosure loading to prevent
reulceration and better understand the mechanism of titration of steps and standing with return to
function.

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RI
[H1]Question 9

In an adult with diabetes, do physical fitness and activity optimize long-term quality of life as well as

SC
reduce health care costs?

[H2]Recommendation V

U
All health care providers should encourage aerobic exercise, strength training, and/or physical activity

AN
for adults who have diabetes and can exercise safely to optimize long-term quality of life as well as
reduce health care costs (evidence quality: C; recommendation strength: weak).

[H3]Aggregate evidence quality M

Evidence included 5 interventional studies and 1 case-control study. Five found that physical fitness and
activity optimize long-term quality of life,61–65 and 1 demonstrated reduced health care costs for adults
D
with diabetes.55 Three of these were not randomized55,62,65 and none were blinded. Five studies were
level II quality,55,61,63–65 and 1 was level III.62 This is rated as C level or weak evidence.
TE

[H3]Benefits

Aerobic exercise or physical activity optimizes long-term quality of life and reduces health care costs.
EC

[H3]Risk, harm, and cost

The risks are similar to any exercise or activity, including both aerobic training and resistance training,
RR

are typical of exercise for everyone and include overuse injury, fatigue, and death. In addition to the
typical exercise risks, hypoglycemic episodes also pose a risk for people with diabetes.3

[H3]Benefit-harm assessment
CO

There is a preponderance of benefit for aerobic exercise and physical activity for people with diabetes.

[H3]Value judgments
N

The guiding principle behind the question development was to highlight benefits of engaging in aerobic
exercise, strength training, or general physical activity for adults with diabetes. These may positively
U

affect quality of life and reduce costs.

[H3]Intentional vagueness

The recommendation of who should encourage aerobic exercise or physical activity for this population
was intentionally vague to allow for inclusivity of all qualified health care providers. Additionally, the
activity intensity within the recommendation was intentionally vague due to limited research on the
impact of intensity on quality of life and health care costs to guide more specific recommendations.

[H3]Role of patient preferences

Self-selected activity should be considered as appropriate. Patient preferences were not discussed in the
included studies, but self-selection of activity and goals may improve adherence. Previous studies report
that higher levels of self-efficacy and behavioral control with exercise improve adherence in those with

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chronic disease.23

[H3]Exclusions

RI
For exercise safety, exercise modifications should be made for any adult with disease conditions that
contraindicate a specific exercise intensity. Further, exercise should be performed only by adults within

SC
safe glycemic ranges. Colberg et al24 provide detailed guidance on the management of glycemia with
exercise.

U
[H3]Implementation and audit

AN
Clinicians may consider incorporating exercise prescriptions into the EMR as part of the complete plan of
care for patients. Using scripted phrases or drop-down menu choices may increase implementation and
improve standardization to allow for better auditing of outcomes. Finally, an annual audit of clinician
use of an exercise prescription would serve to reinforce implementation.
M
[H3]Differences of opinion

There were no differences of opinion.

D

[H3]Supporting evidence and clinical interpretation

TE

Aerobic exercise was predominant in the studies. Three studies used aerobic exercise solely,55,63,65 2
used a combination of aerobic exercise and strengthening,62,64 and the last was a cross-sectional study
EC

which analyzed patients’ fitness and health-related quality of life prior to 2 aerobic exercise trials (Tab.
9).61 The study of Abdelbasset et al63 investigated the effect of aerobic exercise on quality of life in
participants with diabetes who sustained burns. Although this study focused on participants with burns,
they all had diabetes; therefore, this study answered our question.
RR

[H3]Research recommendation

Research is needed that assesses health-related quality of life and includes cost analysis of health care.
CO

Additionally, research is needed that assesses the relationship of physical activity and exercise, based on
intensity, to health-related quality of life and health care costs.
N

[H1]Discussion
U

The purpose of this CPG was to review and assess previously published guidelines and address gaps
within the guidelines specific to identifying screens and interventions to prevent an initial DFU or future
reulceration, best screening tools and interventions to assess and affect mobility impairments, best tools
to measure and interventions to address reduced physical fitness and activity, best approach to
reloading the foot after ulceration closure and, finally, whether improvement in physical fitness will
positively change quality of life and health care costs. During the process of developing this CPG, some
of the questions were answered by updates to a DFU-related CPG6 and 1 question was answered by a
CPG addressing mobility assessment in neurologically involved patients.12 Given that people with
diabetes often develop neurologic changes (eg, diabetic peripheral neuropathy), the GDG determined
this was an appropriate reference to another CPG.

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With the GDG’s focus on the remaining questions, the resulting importance of this guideline is to
provide a review of literature to address how to treat patients so as to best recognize and address
deficits in fitness and functional mobility. These areas are commonly addressed by physical therapists

RI
and explicit guidance may improve consistent inclusion of these components within the standard of
care. Beyond addressing fitness and mobility, prevention of initial DFUs as well as recurrent DFUs is also

SC
critical.

Exercise improves fitness and physical activity in adults with diabetes. This can be achieved with a broad
range of exercises, especially if the exercise is patient selected. While much emphasis in previous

U
guidelines is on the effects of exercise on glucose management, blood pressure control, and other

AN
physiologic markers, exercise also has a positive impact on fitness, quality of life, and the cost of health
care.3 For patients to consistently benefit from exercise, health care providers should test the
cardiovascular health and fitness of adults with diabetes whenever they access the health care system,
rather than waiting until they present with a severe complication such as a DFU.
M
Offloading critical for DFU healing is well reported. Existing DFU-related CPGs provide clear direction for
the treatment of DFUs until closure.6,8,9 The direction of postclosure care including a plan for the
D
reloading process is a critical step toward the reduction of DFU recurrence. Expert opinion provides
some direction for the reloading process, but little data-driven evidence exists to clarify the process.
TE

While some evidence is clear, there are several areas that have gaps in the literature and a definite need
for focused research. The effects of exercise on the wound healing process and the assessment of
EC

methods to reload a newly reepithelialized ulcer to prevent recurrence are research areas of high
priority.

[H2]Limitations
RR

There are several limitations to the development and outcome of this CPG. While the literature search
was comprehensive, the search was initiated within 1 facility (ie, Indiana University Health) and
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subsequent searches occurred at a separate facility (ie, Mercer University). The very nature of library
holdings fluctuates. Literature meeting the inclusion criteria could have been missed because of selected
search terms, holdings, or timing of the searches. Furthermore, any studies that were not written in the
English language were not included. Other studies that may have been appropriate lacked psychometric
N

data and thus full assessment regarding those properties was impossible.
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The process of developing this CPG took 8 years. During this time, changes occurred within the GDG
team and the APTA Clinical Practice Guideline Process Manual13 was updated. With the update, 1 of the
quality appraisals used (the Physiotherapy Evidence Database) was different than that described within
the APTA Clinical Practice Guideline Process Manual.13 Despite these changes, this document still went
through appropriate systematic processes.
[H1]Plan for Implementation and Process for Guideline Update

A CPG Implementation Team was created to determine needed resources and materials to drive
knowledge translation which includes education and integration into PT practice. This group identified
activities and products that needed knowledge translation and will evaluate the effectiveness of the CPG
in changing practice. To better implement these guidelines, beyond specifically identified strategies for
each recommendation, a checklist (Suppl. Mat. 5) can be used upon intake for all people with diabetes

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to facilitate prevention of initial ulceration and reulceration. Included within the checklist are the skin
assessment, range of motion, monofilament testing, readiness to change assessment, and diabetes
management (diabetes knowledge, control, and footwear). Also, resources to support implementation

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for electronic medical records (ie, phrases, triggers) (Suppl. Mat. 6) and knowledge acquisition with
journal club article support are available (Suppl. Mat. 7).

SC
Preliminary findings of the GDG for this guideline were presented at the APTA Combined Sections
Meeting in 2023. This CPG will be open access, with the support of APTA and ACEWM. The Journal of
Clinical Electrophysiology and Wound Management will publish an executive summary of this guideline.

U
Awareness of this guideline will be further facilitated using social media highlights, ACEWM newsletters,

AN
and digital tools (eg, a podcast). Additionally, further development of support materials is planned and
will appear on the ACEWM website.

CPGs should be updated every 5 years following publication according to guideline development best
M
practice. Planned updates will include repeated searches of the literature for new, best available
evidence. A similar approach will include the use of software (eg, Covidence) to facilitate the process to
include or exclude articles (removal of duplicates, assessment by title/abstract, full-text review),
D
perform critical appraisal, and perform extraction. The ACEWM has a plan in place to ensure this
guideline will be updated.
TE

[H1]Summary

It is important to use existing CPGs regarding many aspects for the care of people with diabetes and
EC

DFUs.6,8,9,66 In addition, other aspects of care are important to include. Physical fitness and activity
should be encouraged and measured in adults with diabetes and with or without foot ulceration, ideally
using measurement tools with demonstrated psychometric properties (eg, handgrip strength test, CSRT,
RR

TUG Test, 6MWT, and 30STS test). Exercise and physical activity should be prescribed according to the
physiologic response of an adult with diabetes to exercise, skin integrity, and other comorbidities, while
incorporating the patient’s preferences and considering their resources. All health care providers should
CO

encourage aerobic exercise or physical activity in adults with diabetes safe to exercise to optimize long-
term quality of life and reduce health care cost. Finally, following the closure of a DFU, tissue may be
reloaded, maintaining moderate to maximal offloading, especially during the first 3 months; slowly
N

titrating return to shoe wear using a wear schedule and appropriate “diabetic” footwear. Further
research is necessary to better support specific guidelines for these recommendations, particularly
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those based on expert opinion.

Contributions

Deborah M. Wendland (Conceptualization [Equal], Formal analysis [Equal], Funding acquisition [Equal],
Methodology [Equal], Writing - original draft [Lead], Writing - review & editing [Equal]), Elizabeth A.
Altenburger (Conceptualization [Equal], Formal analysis [Equal], Funding acquisition [Equal],
Methodology [Equal], Project administration [Lead], Writing - original draft [Equal], Writing - review &
editing [Equal]), Shelley B. Swen (Formal analysis [Equal], Writing - original draft [Equal], Writing - review

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& editing [Equal]), Jaimee D. Haan (Conceptualization [Equal], Formal analysis [Equal], Methodology
[Equal], Writing - original draft [Equal], Writing - review & editing [Equal]).

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Acknowledgements

SC
The Indiana University Health Librarian Christine Bockrath provided support for initial literature searches
for this project. Secondary search support was provided with support from Mercer University Library

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services.

The Guideline Development Group appreciates the efforts and assistance provided by the following

AN
individuals who participated in the critical appraisal of articles: Capt. Kathleen O’Neill, Janice Loudon,
Tarang Kumar Jain, Ruth Ann F. Burns, Mary Jamison, Celeste Rochelle, Amanda Church, Jennifer Miller,
Michelle Kunsman, Jonathon Weinhold, Kelly Lloyd, Kim Levenhagen, Michelle Ramirez.
M
The Guideline Development Group appreciates the efforts of Cordell Atkins and Mark Cornwall in the
concept development, data collection, data analysis, and consultation for these guidelines.
D
The Guideline Development Group appreciates Cordell Atkins for his role in funding procurement for the
development of these guidelines.
TE

The following individuals reviewed a draft of the guidelines and provided feedback: Kristin Bailey, Mark
Cornwall, Jill Heitzman, Glenn Irion, Richard Kaufman, Harriett Loehne, and Nancy M. Strange.
EC

Funding
RR

The American Physical Therapy Association (APTA) Academy of Clinical Electrophysiology and Wound
Management (ACEWM) commissioned the development of an evidence-based CPG to address the
paucity of information regarding people with a DFU related to areas that physical therapists address.
CO

Disclosures
N

The authors completed the ICMJE Form for Disclosure of Potential Conflicts of Interest and reported no
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conflicts of interest.

Preliminary findings from this guideline were presented at the APTA Combined Sections Meeting,
February 23–25, 2023, San Diego, California, USA; and at the APTA Combined Sections Meeting,
February 21–24, 2018, New Orleans, Louisiana, USA.
References

1. Centers for Disease Control and Prevention. National Diabetes Statistics Report Website. Accessed
August 2, 2022. https://www.cdc.gov/diabetes/data/statistics-report/index.html.

2. Armstrong DG, Boulton AJM, Bus SA. Diabetic foot ulcers and their recurrence. Ingelfinger JR, ed. N
Engl J Med. 2017;376(24):2367-2375. doi:10.1056/NEJMra1615439

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3. ElSayed NA, Aleppo G, Aroda VR, et al. 5. Facilitating positive health behaviors and well-being to
improve health outcomes: standards of care in diabetes—2023. Diabetes Care.
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4. ElSayed NA, Aleppo G, Aroda VR, et al. 12. Retinopathy, neuropathy, and foot care: standards of

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care in diabetes—2023. Diabetes Care. 2023;46(Supplement_1):S203-S215. doi:10.2337/dc23-S012

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22. Wendland D, Kline P, Simmons L, Sinacore D. The effect of exercise, physical activity, stepping
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23. Ricke E, Dijkstra A, Bakker EW. Prognostic factors of adherence to home-based exercise therapy in
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2020;17(4). doi:10.3390/ijerph17041317

44. Szilagyi B, Kukla A, Makai A, Acs P, Jaromi M. Sports therapy and recreation exercise program in type

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doi:10.1111/dom.13198
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47. MacDonald CS, Johansen MY, Nielsen SM, et al. Dose-response effects of exercise on glucose-
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Clin Proc. 2020;95(3):488-503. doi:10.1016/j.mayocp.2019.09.005

48. Duruturk N, Özköslü MA. Effect of tele-rehabilitation on glucose control, exercise capacity, physical
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doi:10.1016/j.pcd.2019.03.007
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49. Wibowo RA, Nuramalia R, Nurrahma HA, et al. The effect of yoga on health-related fitness among
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50. Nielsen PJ, Hafdahl AR, Conn VS, Lemaster JW, Brown SA. Meta-analysis of the effect of exercise
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51. Mendes R, Sousa N, Themudo-Barata J, Reis V. Impact of a community-based exercise programme

on physical fitness in middle-aged and older patients with type 2 diabetes. Gac Sanit.
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doi:10.1007/s00421-017-3540-1

53. Krishnan S, Tokar TN, Boylan MM, et al. Zumba dance improves health in overweight/obese or type
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54. Lehmann R, Kaplan V, Bingisser R, Bloch KE, Spinas GA. Impact of physical activity on cardiovascular

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55. Di Loreto C, Fanelli C, Lucidi P, et al. Make your diabetic patients walk: long-term impact of different

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amounts of physical activity on type 2 diabetes. Diabetes Care. 2005;28(6):1295-1302.

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57. Gary Liguori. ACSM’s Guidelines for Exercise Testing and Prescription Eleventh Edition. Eleventh
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58. McGuire J. Transitional off-loading: an evidence-based approach to pressure redistribution in the
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60. Fernando ME, Woelfel SL, Perry D, et al. Dosing activity and return to preulcer function in diabetes-
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61. Bennett WL, Ouyang P, Wu AW, Barone BB, Stewart KJ. Fatness and fitness: how do they influence
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2008;6(101153626):110. doi:10.1186/1477-7525-6-110

62. Molsted S, Jensen TM, Larsen JS, et al. Changes of physical function and quality of life in patients
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63. Abdelbasset WK, Abdelhalim NM. Assessing the effects of 6 weeks of intermittent aerobic exercise
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on aerobic capacity, muscle fatigability, and quality of life in diabetic burned patients: Randomized
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64. MacDonald CS, Nielsen SM, Bjørner J, et al. One-year intensive lifestyle intervention and
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65. Wiesinger GF, Pleiner J, Quittan M, et al. Health related quality of life in patients with long-standing
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67. Look AHEAD Research Group, Wing RR. Long-term effects of a lifestyle intervention on weight and
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PT
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RI
SC
U
AN
M
D
TE
EC
RR
CO
N
U
Table 1. Recommendations and Action Statements

Recommendation Action Statement Evidence Strength of

Quality Recommendation
I Physical therapists and other health care providers D Weak
who prescribe exercise for adults with a diabetic foot

PT
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ulcer may prescribe interventions to maintain
cardiovascular health and muscular fitness while
minimizing weight bearing on the foot. In addition, an

RI
assistive device may be used as needed to improve
balance and further reduce weight bearing in an adult

SC
with a current diabetic foot ulcer.
II Physical therapists and other health care providers D Weak
who evaluate physical fitness in adults with diabetes

U
should measure physical fitness, including flexibility,
strength, cardiorespiratory fitness, balance, and

AN
motor agility (evidence quality: C; recommendation
strength: weak), AND may measure the level of
physical activity, such as step counting and standing,
across the continuum of care of an adult with
M
diabetes.
IIIa Physical therapists and other health care providers A Strong
who prescribe exercise should prescribe a progressive
D
moderate- to vigorous-intensity exercise program
including aerobic and resistance training to adults
TE

with diabetes after considering the patient's disease

state and limits for exercise AND depending on the
patient's physiologic response to exercise in
EC

accordance with the patient's preference and

resources.
IIIb Physical therapists and other health care providers B Moderate
who prescribe exercise may use activity monitor–
RR

based counseling to increase physical activity.

IV Physical therapists and other health care providers D Weak
managing closed diabetic foot ulcers may titrate
CO

tissue reloading (eg, standing, walking) on a newly

closed diabetic foot ulcer, maintaining moderate to
maximal offloading, especially during the first 3
months, and slowly titrating a return to shoe wear
N

using a wear schedule.

V All health care providers should encourage aerobic C Weak
U

exercise, strength training, and/or physical activity for

adults who have diabetes and can exercise safely to
optimize long-term quality of life as well as reduce
health care costs.
Table 2.

Questions 5 Through 9 Described in Population, Intervention, Comparator, and Outcome Termsa

Question Population Intervention(s) Comparator(s) Outcome(s)

5 Adults with Various No change in Improved mobility in the

PT
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diabetes and fitness/exercise exercise or context of wound healing
current foot routines with various standard exercise
ulceration intensities, including used as an

RI
aerobic and alternative
resistance training exercise
6 Adults with Not applicable Not applicable Psychometric properties of

SC
diabetes tests and measures
assessing physical fitness
and activity

U
7 Adults with Various No change in Physical fitness (eg, VO2max,

AN
diabetes fitness/exercise exercise or VO2peak, % METs, sit-to-
routines with various standard exercise stand test, 6-min walk test,
intensities, including used as an and blood pressure)
aerobic and M alternative
resistance training exercise
8 Adults with Progressive reloading Lack of Presence or absence of
diabetes and closed of recently closed progressive ulcer recurrence
D
ulceration ulceration reloading of
recently closed
TE

ulceration
9 Adults with Physical fitness and Lack of physical Measures of quality of life;
diabetes activity fitness and health care costs
EC

activity

a
% METs = metabolic equivalents, measured as percentages; VO2max = maximum oxygen consumption;
RR

VO2peak = peak oxygen consumption.

CO
N
U
Table 3.

Title and Abstract Review Guidelinesa

Parameter Description
Exclusion criteria Nonadults or adults without diabetes

PT
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Nonscientific articles: opinion papers, case reports, case
series
Descriptive studies

RI
Nonsystematic literature reviews
Non-English articles

SC
Animal studies
Participants younger than 18 y
Inclusion criteria, including quality Adult population

U
appraisal tool to be used
Experimental studies

AN
RCTs (PEDro)
Systematic reviews (AMSTAR 2)
Meta-analyses (AMSTAR 2)
M
Retrospective studies (choice of diagnostic or prognostic)
Diagnostic/prognostic studies (SIGN)
D
Terms for exclusion of articles Wound care (treatment of ulcer)
TE

Pediatric population
Case studies
Non–peer-reviewed studies
EC

a
AMSTAR 2 = measurement tool to assess systematic reviews; PEDro = physiotherapy evidence
database; RCTs = randomized controlled trials; SIGN = Scottish intercollegiate guidelines network.
RR
CO
N
U
Table 4.

Definitions of Levels of Evidencea

Level of Evidence Definition

I Evidence from high-quality systematic reviews,

PT
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diagnostic studies, prospective studies, or RCTs
II Evidence from lower-quality diagnostic studies,
prospective studies, or RCTs

RI
III Evidence based on retrospective or case-control
studies
IV Evidence based on case series studies

SC
V Expert opinion
a
RCTs = Randomized controlled trials.

U
AN
M
D
TE
EC
RR
CO
N
U
Table 5.

Grading of Evidencea

Grading of Evidence Associated Level of Obligation Definition

A Strong Recommendation based on high

PT
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certainty for at least a moderate
benefit/cost (based on level 1 or
2 evidence predominating)

RI
B Moderate Recommendation based on high
certainty for a slight or
moderate benefit/cost or

SC
moderate certainty that
benefit/cost is moderate (based
on level 2 evidence

U
predominating or 1 high-quality
randomized controlled trial)

AN
C Weak Recommendation with
moderate certainty for slight
M benefit/cost or weak certainty
for moderate benefit/cost
(based on level 2–5 evidence)
D Theoretical Recommendation supported by
D
basic science (not clinical trials)
or peer-reviewed, published
TE

expert opinion
P Best practice Practice recommendation
according to practice norms in
EC

which there is a clear benefit;

expert opinion
R Research Limited/absent evidence or
equivocal conclusions on
RR

present research
a
Modified from Table 7 in the APTA Clinical Practice Guideline Process Manual.13
CO
N
U
Table 6.

Question Status and Literature Included

PT
Question No. of Initial No. of Studies No. of Studies No. of Studies No. of

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Studies Excluded Excluded in Which Full- Remaining
Found Because of Because Text Review Studies
Duplication Irrelevant was

RI
Completed
1a

SC
2a
3a
4b

U
AN
5 268 18 246 4 3
6 117 0 85 32 1
7 71 1 38 32 28
8 107 5 64 38 0
9 138 3
M 116 19 6
D
a
Removed because adequately addressed by the International Working Group on the Diabetic Foot 2019
guideline.6
TE

b
Removed because adequately addressed by the Academy of Neurological Physical Therapists outcome
measure guideline.12
EC
RR
CO
N
U
 PT

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Table 7.

Psychometric Data for Assessment of Fitness, Including Physical Function25,a

RI
Fitness Test(s) Construct Measured Relative Reliability Parameter and Score Parameter of Measurement Error % SEM % CV

SC
Assessed

ICC 95% CI SEM MDC

U
AN
Handgrip Upper body muscular 0.98 (dominant arm) 0.95–0.99 1.4 3.89 kg 5.2 10.62
strength test strength
Handgrip Upper body muscular 0.98 (nondominant 0.96–0.99 1.56 4.32 kg 6.3 10.52

M
strength test strength arm)
Handgrip Upper body muscular 0.98 (bimanual grip 0.96–1.00 1.49 4.13 kg 5.8 9.55
strength test strength strength, kg)

D
Right chair sit Lower body flexibility 0.94 0.84–0.98 2.7 7.5 cm 22 39.22
and reach
test, cm
Left chair sit Lower body flexibility 0.93
TE 0.82–0.97 3.25 9.01 cm 26.4 47.56
EC
and reach
test, cm
Timed “Up & Motor agility/mobility 0.98 0.95–0.99 0.31 0.85 s 3.5 6.46
RR

Go” Test

6-min walk Cardiorespiratory 0.99 0.96–1.00 9.88 27.37 m 2.5 5.12

test fitness
CO

30-s sit-to- Lower body strength 0.92 0.79–0.98 1.21 3.35 times 9.6 17.6
stand test
N
U
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PT
RI
SC
CV = coefficient of variation; MDC = minimal detectable change; SEM = standard error of measurement.

U
AN
M
D
TE
EC
RR
CO
N
U
a
 PT
Table 8.

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Risk of bias

RI
Study Specified Randomization Concealed Similarity Participant/Provider Assessor At Least 1 Intention Funding Source
Eligibility Allocation of Blinding Blinding Outcome to Treat Reported

SC
Criteria Groups for >85% of
at Participants
Baseline

U
Lehmann et In kind support from
+ − − NA − − + +

AN
al54 (1997) Boehringer-Mannheim
Switzerland and Novo-
Nordisk Switzerland

M
Kirk et al36 None reported
(2003)
+ + + + − − + −

D
Di Loreto et None reported
al55 (2005)
+ + − + − − + −
Cauza et
al33 (2005)
+ + −
TE
− − − + − Jubilaumsfond of the
Austrian National Bank
(Project no. 8537)
EC
Praet et al37 Dutch Healthcare
(2008)
+ + + + − + + + Innovation Foundation
research grant from
RR

‘OZ-zorgverzekeringen’
healthcare insurance
company; Dutch
CO

Ministry of Health,
Welfare and Sports
grant; in kind supplies
support from A.
N

Menarini Diagnostics
U
 PT
Benelux, RSscan

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International

Jakicic et NIDDKD; National

+ + − + − + + +

RI
al38 (2009) Heart, Lung, and Blood
Institute; CDC grants

SC
Johnson et Heart and Stroke
al39 (2009)
+ + − + − − + + Foundation of Canada

U
Reid et al40 DARE trial supported by
(2010)
+ + + + − + + + grants from the

AN
Canadian Institutes of
Health (research grant
MCT-44155) and the
Canadian Diabetes

M
Association (The Lillian
Hollefriend Grant); and
various other grants to

D
support team members
(see p. 639–640 of

Look
AHEAD
+ + −
TE
+ − + + +
reference)

DHHS through
cooperative
EC
Research agreements from NIH;
Group and NIDDKD; National
Wing67 Heart, Lung, and Blood
RR

(2010) Institute; National

Institute of Nursing
Research; National
Center on Minority
CO

Health and Health

Disparities; Office of
Research on Women’s
N

Health; CDC;
U
 PT
Department of

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Veterans Affairs;
among other facilities
and research centers

RI
(see p. 1574 of
reference)

SC
Ng et al29 National Medical
(2010)
+ + + + − + + + Research Council of
Singapore

U
(NMRC/0728/2003); in

AN
kind support of Abbott
Laboratories

Karstoft et Danish Centre for

al31 (2013)
+ + − + − + − + Strategic Research in

M
Type 2 Diabetes (grants
09-067009 and 09-
075724); Danish

D
National Research
Foundation (02-512-55)

Espeland et
al45 (2013)
+ + − TE
− − + + + NIDDKD; National
Heart, Lung, and Blood
EC
Institute; CDC

Johannsen National Institutes of

et al41
+ + − + − + + + Health (DK-068298)
RR

(2013)

Andersen FIFA Medical

et al30
+ − − + − − + + Assessment and
CO

(2014) Research Center (F-

MARC) and Nordea-
fonden, Denmark
N
U
 PT
de Sousa et Grants from the State
− + − + − − − −

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al28 (2014) of Sao Paulo Research
Foundation

RI
Krishnan et None reported
al53 (2015)
+ − − − − − − −

SC
Senechal et NIH Grant DK068298
al42 (2015)
+ + − + − + + +

U
Mendes et Portuguese Foundation
al51 (2016)
+ − − − − − − − for Science and

AN
Technology
(SFRH/BD/47733/2008)

Stoa et al52 No external funding

+ − − + − − + −

M
(2017)

Winding et TryFonden; Danish

al46 (2018)
+ + + + − − + − National Research

D
Foundation (DNRF55);
Capitol Region of

TE Denmark, Novo Nordisk

Foundation, and Danish
Diabetes Academy
EC
Duruturk Authors report no
and
+ + + + −/+ + + − conflict of interest
Özköslü48
RR

(2019)

Szilagyi et Authors report no

al44 (2019)
+ + + + − + − − conflict of interest
CO

MacDonald TryFonden; Danish

et al47
+ + + + − + + + Council for Strategic
(2020) Research, grants 09-
N

067009 and 09-075724;

U
 PT
Danish Diabetes

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Academy grant; in kind
support by Bayer A/S

RI
Dominguez- Regional Department of
Munoz et
+ + + + + + − + Economy and
al43 (2020) Infrastructure of the

SC
Government of
Extremadura and
European Social Fund

U
(PD16008)

AN
a
– = did not meet criteria; + = did meet criteria; −/+ = partially present; CDC = centers for disease control; DARE = diabetes aerobic and resistance
exercise study; DHHS = department of health and human services; FIFA = federation internationale de football association; NA = not applicable;
NIDDKD = national institute of diabetes and digestive and kidney diseases; NIH = national institutes of health.

M
D
TE
EC
RR
CO
N
U
Table 9.

Health-Related Quality of Life (HRQOL) and Description of Costsa

Study Participants Type of Exercise Effects on HRQOL Impact on Costs

Wiesinger et al65 Type 1 DM; mean Aerobic exercise Significant

PT
(2001) age = 40 y; with stationary bike improvement in

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treatment and for 1 h 2x/wk for 2 HRQOL in treatment
control groups wk, 3x/wk for group compared to
remainder of 4 mo control group

RI
Bennett et al61 Type 2 diabetes; VO2 peak fitness test Increased fitness
(2008) mean age = 56.9 y used; no treatment correlated with
intervention higher HRQOL

SC
U
Abdelbasset and Type 2 diabetes and Moderate-intensity Significant
Abdelhalim63 (2020)

AN
burns; mean ages = intermittent aerobic improvement in
47.8 y for treatment exercise for 40 Burns Specific
group and 46.3 y for min/d 3x/wk for 6 wk Health Scale score
control group in treatment group
M compared to control
group

MacDonald et al64 Type 2 DM; mean Aerobic exercise Significant

(2021) age = 53.6 y for and resistance improvement in
D
treatment group, training for 240–300 HRQOL in treatment
with structured min/wk group compared to
TE

exercise and control group

individual meal
plans; mean age =
56.6 y for standard-
of-care group
EC

Molsted et al62 Type 2 DM; split into Aerobic exercise Positive changes in
(2022) groups by and strength training HRQOL in both
municipality or for 1 h 2x/wk for 12 exercise groups,
hospital wk: interval aerobic more pronounced in
RR

rehabilitation clinic; exercise on municipality group

mean age = 69.8 or ergometer bikes,
62.6 y, respectively circuit training with
aerobic and strength
CO

training exercises
Di Loreto et al55 Type 2 diabetes; Moderate-intensity Significant reduction
(2005) mean age = 62 y aerobic exercise in health care costs
with energy
expenditure of >10
N

METs/h/wk
U

a
DM = Diabetes mellitus; HRQOL = health-related quality of life; METs = metabolic equivalents; VO2
peak= peak oxygen consumption.