On the Move: Center and Home-Based Exercise to Enhance Mobility in Diabetic Foot Ulcer Recovery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Primary Endpoint
- 6-minute walk distance
Study Overview
Brief Summary
Foot ulcers and amputations are a common and feared complication for people with diabetes. People with a diabetic foot ulcer have a higher risk of dying within five years than people with diabetes without an ulcer. At least one in four people with a new diabetic foot ulcer will die within five years, largely due to cardiovascular causes. The reasons for this increased mortality involve decreased mobility.
People with a recently healed diabetic foot ulcer are considered "in remission" as opposed to "cured" because the underlying medical problems (e.g., peripheral neuropathy, peripheral arterial disease) which led to their ulcer are still present. Once in remission, the current standard of care is to slowly increase ambulation with appropriate footwear so as not to promote ulcer recurrence. The problem is that people rarely return to the recommended level of mobility. The ability to safely maintain mobility with aging is critical, as immobility is the leading cause of nursing home admissions.
This is a clinical trial to test the feasibility and acceptability of an exercise regimen that transitions from in-person to home-based. The investigators will also assess if this exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by improving mobility, lower extremity strength, lower extremity tissue perfusion and glycemic control.
Detailed Description
Population: 60 Veterans with a healed foot ulcer in the last 3-15 months
Site: VA Maryland Health Care System (VAMHCS)
Study Duration: Approximately 3 years
Study Design: Randomized, outcome assessor blinded, clinical trial comparing a) a 12-week exercise regimen to b) standard of care
Objectives:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults >= 50 years
- •Diagnosis of diabetes
- •Plantar foot ulcer which healed within the last 3-15 months
- •Two feet (can have healed minor amputations of fore and midfoot)
- •Willing to wear appropriately fitted footwear for exercise regimen
- •Ambulatory without walker
- •Willing to enroll in the PODIMETRICS SmartMat program
- •Able to give written informed consent
Exclusion Criteria
- •Unable to perform the exercise interventions (e.g. due to hearing or visual impairment)
- •Anticipated foot surgery in the next 4 months
- •Participating in another exercise program
- •Severe peripheral arterial disease (Fontaine stage 3 rest pain or 4 ischemic ulcers/gangrene)
- •Current plantar foot ulcer
- •Any other criteria which, in the investigator's opinion, would compromise the ability of a subject to participate safely
Arms & Interventions
12-week exercise regimen
Consistent with current physical activity recommendations for older adults, participants randomized in this arm will be prescribed 5 days/week of exercise, with seated cycling exercise performed on 3 days a week and strength/balance exercise performed 2 days a week.
Intervention: 12-week exercise regimen (Behavioral)
12-week standard of care
Participants in this group will be provided with guidance on the current standard of care. This includes guidance that these patients should slowly increase ambulation with appropriately fitted footwear.
Intervention: 12-week standard of care (Behavioral)
Outcomes
Primary Outcomes
6-minute walk distance
Time Frame: 12 weeks
Using standard procedures participants will be asked to walk as far as possible in 6 minutes along a 100-foot course. Primary clinical outcome is total distance covered.
Secondary Outcomes
- Perfusion(12 weeks)
- Glycemic Control(12 weeks)
- Acceptability and Feasibility(12 weeks)
- Adherence to the exercise regimen(12 weeks)
- SmartMat metrics(12 weeks)
- Community Mobility(12 weeks)
- Mobility Function(12 weeks)
- Physical Activity(12 weeks)
- Muscular strength(12 weeks)