N/A
N=24
Effects of a Exercise Program on Health Outcomes in People With Diabetic Foot Ulcers
Diabetic Foot Ulcer · Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT03002155 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Glycated Hemoglobin (HbA1c) at 12-week Session — 8.0; 7.0 percentage of HbA1c — p=.26
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EnhanceFitness community exercise program (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycated Hemoglobin (HbA1c) at 12-week Session |
8.0; 7.0 | .26 |
| PRIMARY Chair Stand Test (5x Sit-to-Stand) at 12-week Session |
14.4; 17.1 | 0.38 |
| SECONDARY PROMIS-Global at 12-week Session |
47.5; 39.2; 50.7; 45.7 | 0.24 |
| SECONDARY PROMIS-Depression at 12 Weeks |
48.4; 53.8 | 0.81 |
| SECONDARY PROMIS-Physical Function |
44.6; 37.0 | 0.03 sig |
| SECONDARY Retention |
7; 11 | — |
| SECONDARY Adherence |
57.1 | — |
| SECONDARY EnhanceFitness Program Evaluation |
4.8 | — |
| SECONDARY Adverse Events |
0; 0 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03002155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.