Diabetic Foot UlcerNCT03002155
Effects of a Exercise Program on Health Outcomes in People With Diabetic Foot Ulcers
A study testing EnhanceFitness community exercise program in people with Diabetic Foot Ulcer and Diabetes Mellitus, Type 2, run by University of Washington at 1 site in United States.
Trial summary
People with diabetes are at risk for life altering complications, including diabetic foot ulcers. To heal a diabetic foot ulcer, people are often required to refrain from bearing weight on their affected limb for months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetes Mellitus, Type 2
- What is being tested?
- EnhanceFitness community exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or more years of age
- diagnosis of type 2 diabetes
- undergoing treatment for a Wagner grade II, III, or IV diabetic foot ulcer
- able to attend regular exercise classes and two data collection sessions
Who cannot join
- medical conditions where aerobic or resistance exercise is contraindicated (e.g., uncontrolled cardiovascular problems)
- a score of less than 18 on the Montreal Cognitive Assessment indicating moderate cognitive impairment
- response from primary physician requesting that the participant not engage in exercise
- current participation in a regular exercise program (more than 30 minutes, more than 2 times a week)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Community Exercise Program on Physical, Physiological, and Psychosocial Health Outcomes in People With Diabetic Foot Ulcers
People with diabetes are at risk for life altering complications, including diabetic foot ulcers. To heal a diabetic foot ulcer, people are often required to refrain from bearing weight on their affected limb for months. These long periods of non-weight bearing can result in severe physical deconditioning, putting these individuals at risk for further health decline. The goal of this pilot, randomized controlled trial is to evaluate the effects of a seated exercise program on clinically meaningful outcomes in people with diabetic foot ulcers. The long-term aim of this research is to improve overall health and quality of life in people with complications from diabetes.
Read the detailed description
People with diabetes are at risk for life-altering complications and comorbidities. One of the most serious complications is a diabetic foot ulcer, which significantly increases risk for limb amputation. To heal a diabetic foot ulcer, patients are often instructed to refrain from bearing weight on the affected limb. This non-weight bearing protocol results in extended periods of inactivity that can lead to severe physical deconditioning, including diminished strength, endurance, and flexibility. EnhanceFitness, a community exercise program designed for older adults, holds classes that can be adapted for people who are non-weight bearing due to a healing foot ulcer. These exercise classes focus specifically on strength training, aerobic fitness, and stretching - activities that can counteract progressive deconditioning in people with diabetic foot ulcer. Health benefits associated with exercise in people with diabetes are well-established. However, for those experiencing declines in health and physical function because of healing protocols for a diabetic foot ulcer, the potential benefits of exercise are not yet known. The proposed project aims to address this gap in diabetes research.
The long-term goal of this research is to improve the health and quality of life of people with complications from diabetes. The specific goal of this project is to evaluate the effect of a seated community exercise program, EnhanceFitness, on clinically-meaningful outcomes in people with diabetic foot ulcers. Study investigators will recruit people with diabetic foot ulcers from local wound care clinics and randomly assign them to two groups. The first group will engage in EnhanceFitness, an existing community fitness program appropriate for people with weight-bearing restrictions due to wound-healing protocols. The second group will receive the standard of care, which does not include exercise recommendations. To assess the effectiveness of the seated exercise program, the investigators will compare important health outcomes between people with diabetic foot ulcers participating in EnhanceFitness and a control group with diabetic foot ulcers. Specifically, the investigators will assess physical and physiological outcomes, including glycated hemoglobin (HbA1c), lower-extremity strength, and wound healing. The investigators will also measure psychosocial outcomes, such as depression, perceived physical function, overall health, and self-reported ability to continue with exercise. Further, the investigators will evaluate the feasibility of conducting research assessing the effects of seated exercise in people with foot ulcers. The data collected in this pilot research will be used to apply for large, extramural funding that aims to mitigate physical deconditioning in people with diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcer, Diabetes Mellitus, Type 2
- Being tested
- EnhanceFitness community exercise program
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnhanceFitness community exercise programOther
Also called Seated Exercise, Group exercise, Fitness program
Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | EnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks. Receives: Other: EnhanceFitness community exercise program |
| Control | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin (HbA1c) at 12-week Session
Average blood glucose over a three-month period
Measured: 12 weeks post-intervention
Chair Stand Test (5x Sit-to-Stand) at 12-week Session
Measure of functional mobility and lower extremity strength. The 5x Sit-to-Stand test measures the total amount of time that it takes a individual to stand up and sit down in a chair five times. The individual is asked to stand up and sit down five times as quickly as they are able. The research staff started the stopwatch on "begin" and stopped timing after the individual had completed the fifth round of standing/sitting. Faster times are better, and scores are recorded in seconds.
Measured: 12 weeks post-intervention
Secondary outcomes (7)
PROMIS-Global at 12-week Session
Patient-Reported Outcome Measurement Information System (PROMIS) Global 10-item short form. Results are reported as a T-score. PROMIS-Global is a self-reported questionnaire to assess global health. T-scores are calculated for 2 subscales- physical health and mental health. A higher T-score indicates better physical health and better mental health; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores for physical health range from 16.2 to 67.7. T-scores for mental health range from 21.2 to 67.6.
Measured: 12 weeks post-intervention
PROMIS-Depression at 12 Weeks
Patient-Reported Outcome Measurement Information System (PROMIS) Depression 4-item short form. Results are reported as a T-score. PROMIS-Depression is a self-reported questionnaire to assess depression. A higher T-score indicates greater depression; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores range from 41.0 to 79.4 for the 4-item short form.
Measured: 12 weeks post-intervention
PROMIS-Physical Function
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function 11-item short form. Results are reported as a T-score. PROMIS-Physical Function is a self-reported questionnaire to assess physical function. A higher T-score indicates better physical function; a T-score of 50 indicates the general population mean with a standard deviation of 10. T-scores range from 11.9 to 57.9 for the 11-item short form.
Measured: 12 weeks post-intervention
Retention
Feasibility measure- did the participant attend all study data collection sessions?
Measured: Through the end of study participation, approximately 12 weeks
Adherence
Feasibility measure- % classes attended by participants in the intervention group
Measured: Through the end of study participation, approximately 12 weeks
EnhanceFitness Program Evaluation
Feasibility measure, satisfaction with exercise program for participants in the intervention group. This satisfaction measure was designed by EnhanceFitness. It included 5 items, each item was rated by participants as 1 (not at all satisfied) to 5 (very satisfied). Responses for the five questions were summed and divided by 5. Scores ranged from 1-5, with better scored indicating higher satisfaction.
Measured: 12-weeks post-intervention
Adverse Events
Feasibility measure- number of adverse events, if any, that occurred for each participant.
Measured: Through the end of study participation, approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Morgan, University of Washington
- Investigators
- Sara J Morgan, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002155
- Sponsor's protocol ID
- 52222
- Other IDs
- P30DK017047
- Status last verified
- Sep 2022
- First submitted
- 14 Dec 2016
- Last updated
- 6 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Community Exercise Program on Physical, Physiological, and Psychosocial Health Outcomes in People With Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03002155
- Acronym / sponsor ID
- 52222
- Conditions
- Diabetic Foot Ulcer, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2017
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Posted 6 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with diabetes are at risk for life altering complications, including diabetic foot ulcers. To heal a diabetic foot ulcer, people are often required to refrain from bearing weight on their affected limb for months. These long periods of non-weight bearing can result in severe physical deconditioning, putting these individuals at risk for further health decline. The goal of this pilot, randomized controlled trial is to evaluate the effects of a seated exercise program on clinically meaningful outcomes in people with diabetic foot ulcers. The long-term aim of this research is to improve overall health and quality of life in people with complications from diabetes.
Detailed description
People with diabetes are at risk for life-altering complications and comorbidities. One of the most serious complications is a diabetic foot ulcer, which significantly increases risk for limb amputation. To heal a diabetic foot ulcer, patients are often instructed to refrain from bearing weight on the affected limb. This non-weight bearing protocol results in extended periods of inactivity that can lead to severe physical deconditioning, including diminished strength, endurance, and flexibility. EnhanceFitness, a community exercise program designed for older adults, holds classes that can be adapted for people who are non-weight bearing due to a healing foot ulcer. These exercise classes focus specifically on strength training, aerobic fitness, and stretching - activities that can counteract progressive deconditioning in people with diabetic foot ulcer. Health benefits associated with exercise in people with diabetes are well-established. However, for those experiencing declines in health and physical function because of healing protocols for a diabetic foot ulcer, the potential benefits of exercise are not yet known. The proposed project aims to address this gap in diabetes research.
The long-term goal of this research is to improve the health and quality of life of people with complications from diabetes. The specific goal of this project is to evaluate the effect of a seated community exercise program, EnhanceFitness, on clinically-meaningful outcomes in people with diabetic foot ulcers. Study investigators will recruit people with diabetic foot ulcers from local wound care clinics and randomly assign them to two groups. The first group will engage in EnhanceFitness, an existing community fitness program appropriate for people with weight-bearing restrictions due to wound-healing protocols. The second group will receive the standard of care, which does not include exercise recommendations. To assess the effectiveness of the seated exercise program, the investigators will compare important health outcomes between people with diabetic foot ulcers participating in EnhanceFitness and a control group with diabetic foot ulcers. Specifically, the investigators will assess physical and physiological outcomes, including glycated hemoglobin (HbA1c), lower-extremity strength, and wound healing. The investigators will also measure psychosocial outcomes, such as depression, perceived physical function, overall health, and self-reported ability to continue with exercise. Further, the investigators will evaluate the feasibility of conducting research assessing the effects of seated exercise in people with foot ulcers. The data collected in this pilot research will be used to apply for large, extramural funding that aims to mitigate physical deconditioning in people with diabetic foot ulcers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: EnhanceFitness community exercise programEnhanceFitness exercise class, 1 hour, 3 times a week, duration of 12 weeks. |
| Control | No intervention | –Usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 or more years of age
- diagnosis of type 2 diabetes
- undergoing treatment for a Wagner grade II, III, or IV diabetic foot ulcer
- able to attend regular exercise classes and two data collection sessions
Key exclusion criteria (4 listed)
- medical conditions where aerobic or resistance exercise is contraindicated (e.g., uncontrolled cardiovascular problems)
- a score of less than 18 on the Montreal Cognitive Assessment indicating moderate cognitive impairment
- response from primary physician requesting that the participant not engage in exercise
- current participation in a regular exercise program (more than 30 minutes, more than 2 times a week)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnhanceFitness community exercise programAlso: Seated Exercise, Group exercise, Fitness programLevel I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching. | Other | Exercise |
Primary outcome
Glycated Hemoglobin (HbA1c) at 12-week Session
Time frame: 12 weeks post-intervention
Average blood glucose over a three-month period
Chair Stand Test (5x Sit-to-Stand) at 12-week Session
Time frame: 12 weeks post-intervention
Measure of functional mobility and lower extremity strength. The 5x Sit-to-Stand test measures the total amount of time that it takes a individual to stand up and sit down in a chair five times. The individual is asked to stand up and sit down five times as quickly as they are able. The research staff started the stopwatch on "begin" and stopped timing after the individual had completed the fifth round of standing/sitting. Faster times are better, and scores are recorded in seconds.
7 secondary outcomes
PROMIS-Global at 12-week Session
Time frame: 12 weeks post-intervention
PROMIS-Depression at 12 Weeks
Time frame: 12 weeks post-intervention
PROMIS-Physical Function
Time frame: 12 weeks post-intervention
Retention
Time frame: Through the end of study participation, approximately 12 weeks
Adherence
Time frame: Through the end of study participation, approximately 12 weeks
EnhanceFitness Program Evaluation
Time frame: 12-weeks post-intervention
Adverse Events
Time frame: Through the end of study participation, approximately 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara J Morgan, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EnhanceFitness community exercise program in people with Diabetic Foot Ulcer and Diabetes Mellitus, Type 2, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated Hemoglobin (HbA1c) at 12-week Session (time frame: 12 weeks post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.