Blood flow restriction exercise program for people with peripheral arterial disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Tennessee Medical Center
  Knoxville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Tiffany Johnson, Study Coordinator
• Email: thjohnson@utmck.edu
• Phone: +1865-305-4682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.