REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
The purpose of this study is to evaluate the effects of Blood Flow Restriction (BFR) training on walking function, health-related quality of life, and safety among adults with Peripheral Arterial Disease (PAD). The main aims of the study are: 1. Evaluate change in walking function among patients with PAD undergoing BFR training. The investigators will assess change in Six-Minute Walk Test (6MWT) distance from baseline to post-intervention and 3-month follow-up to compare functional improvements between the BFR group and the two control groups 2. Assess changes in health-related quality of life among patients with PAD undergoing BFR training. The investigators will use the EuroQol 5-Dimension 5-Level (EQ-5D-5L) scale to evaluate quality-of-life changes from baseline to post-intervention and 3-month follow-up across all study arms 3. Evaluate the safety and feasibility of a supervised BFR training program for patients with PAD. The investigators will compare adverse event (AE) and serious adverse event (SAE) rates across study arms, while also monitoring sessional ratings of perceived exertion (RPE), dyspnea, and claudication pain as indicators of symptom response and exercise tolerance. Feasibility will be assessed through enrollment success, intervention adherence, and retention rates across groups
Sponsor: University of Tennessee Graduate School of Medicine
You may qualify if…
- ✓ 1. 18 years of age or older
- ✓ 2. Diagnosed peripheral arterial disease with stable claudication (symptomatic presentation unchanged for 6 months)
- ✓ 3. Ankle-brachial index (ABI) between 0.4 and 0.9.
- ✓ 4. Eligible referral to cardiovascular or pulmonary rehabilitation
- ✓ 5. Prior revascularization permitted if symptoms are stable and other criteria are met
You may not qualify if…
- ✕ 1. Recent change in resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 weeks), or another acute cardiac event
- ✕ 2. Unstable angina
- ✕ 3. Uncontrolled cardiac arrhythmias
- ✕ 4. Symptomatic severe aortic stenosis or other significant valvular disease
- ✕ 5. Decompensated symptomatic heart failure
- ✕ 6. Acute pulmonary embolism or infarction
- ✕ 7. Acute noncardiac disorder likely to interfere with or be worsened by exercise (e.g., infection, thyrotoxicosis)
- ✕ 8. Acute myocarditis or pericarditis
Where it's recruiting
Knoxville
Source: ClinicalTrials.gov · NCT07223437 · last updated 2026-04-29