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NCT07223437NARecruiting

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

Start Date

4/27/2026

Completion Date

4/27/2027

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 Criteria

Age Range: 18 years to No maximum

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. 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 9. Acute thrombophlebitis 10. Physical disability precluding safe or adequate exercise performance 11. Significant electrolyte abnormalities 12. Clinically significant tachyarrhythmias or bradyarrhythmias 13. High-degree atrioventricular block 14. Atrial fibrillation with uncontrolled ventricular response 15. Hypertrophic obstructive cardiomyopathy with resting left ventricular outflow gradient of \>25 mmHg 16. Known active aortic dissection 17. Severe resting arterial hypertension (SBP\>200mmHg or DBP \>110 mmHg) 18. Mental impairment preventing cooperation with study procedures 19. Current pregnancy 20. Moderate to severe peripheral neuropathy 21. Open wounds or compromised skin near BFR cuff site 22. Active DVT or thromboembolic event within the past year

Interventions

BEHAVIORAL

Blood Flow Restriction Cuff System

BEHAVIORAL

Low-load Resistance Training

BEHAVIORAL

High-load Resistance Training

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Conditions

Peripheral Arterial Disease

Locations

University of Tennessee Medical Center

Knoxville, Tennessee 37920

United States