N/A
Completed N=18
Exercise and Weight Loss in PAD
Source: ClinicalTrials.gov NCT02607033 ↗Enrolled (actual)
18
Serious AEs
27.8%
Results posted
Jun 2024
Primary outcomePrimary: Difference in Time to Onset of Calf Pain (Claudication Onset Time) Pre-intervention to Post-intervention — 396; 140 seconds — p=0.028
Summary
This study is designed to examine the added benefits of weight loss to an exercise program in older obese Veterans with peripheral arterial disease. The investigators want to determine if weight loss in addition to exercise will 1) improve walking ability to a greater extent than exercise alone and 2) determine the underlying reasons why walking ability improves by measuring blood flow and the amount of muscle in the leg muscles.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Time to Onset of Calf Pain (Claudication Onset Time) Pre-intervention to Post-intervention |
396; 140 | 0.028 sig |
| PRIMARY Difference in Ankle Brachial Index Pre-intervention to Post-intervention |
0.04; -0.16 | — |
| SECONDARY Score on the Modified Physical Performance Test Post-intervention |
33; 31 | — |
| SECONDARY Change in Muscle Composition of the Calf Muscles Pre-intervention to Post-intervention |
— | — |
Eligibility Criteria
Inclusion Criteria
- BMI >25 kg/m2
- Ankle Brachial Index (ABI) <.90
- Able to participate in a supervised exercise program at the Baltimore VA
- No current plan for surgical revascularization
- Claudication or leg symptoms when walking
Exclusion Criteria
- Unstable angina or a recent heart attack
- Active cancer
- Dementia
- Current foot or leg ulcers
- Already exercise 2x/week or more.
Data sourced from ClinicalTrials.gov (NCT02607033). 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. Informational only — not medical advice.