Blood flow restriction exercise program for people with peripheral arterial disease

REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center

This will test whether supervised blood flow restriction (BFR) resistance exercise helps adults with peripheral arterial disease walk farther and feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 81 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Tennessee Graduate School of Medicine (Academic / other)
• Locations: 1 site (Knoxville, Tennessee)
• Trial ID: NCT07223437 on ClinicalTrials.gov

What this trial studies

This feasibility study compares supervised BFR low-load resistance training with low-load and high-load resistance training in adults with peripheral arterial disease. Participants will undergo a supervised exercise program using a BFR cuff system and standard resistance training protocols, with outcomes measured at baseline, post-intervention, and 3-month follow-up. Primary functional outcome is change in Six-Minute Walk Test distance, and quality of life will be measured with the EQ-5D-5L; safety and adverse events will also be tracked. The trial is conducted at the University of Tennessee Medical Center and is intended to inform larger trials if feasible and safe.

Who should consider this trial

Good fit: Adults aged 18 or older with diagnosed PAD and stable claudication for at least six months, an ankle-brachial index of 0.4–0.9, and eligibility for cardiovascular or pulmonary rehabilitation are ideal candidates.

Not a fit: People with unstable cardiac conditions, recent acute cardiac or pulmonary events, symptomatic severe valvular disease, acute thrombophlebitis, or physical disabilities that prevent safe exercise are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, this approach could help people with PAD improve walking distance and quality of life using lower-intensity resistance exercise.

How similar studies have performed: BFR training has shown promise for improving strength and function in other patient groups, but its application in PAD is relatively novel with only limited preliminary data.

Eligibility criteria

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

Where this trial is running

Knoxville, Tennessee

• University of Tennessee Medical Center — Knoxville, Tennessee, United States (Recruiting)

Study contacts

• Study coordinator: Tiffany Johnson, Study Coordinator

Conditions Peripheral Arterial Disease