REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center
University of Tennessee Graduate School of Medicine
Summary
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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 Exclusion Criteria: 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. Symptom…