Status:
NOT_YET_RECRUITING
REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center
Lead Sponsor:
University of Tennessee Graduate School of Medicine
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Dise...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Diagnosed peripheral arterial disease with stable claudication (symptomatic presentation unchanged for 6 months)
- Ankle-brachial index (ABI) between 0.4 and 0.9.
- Eligible referral to cardiovascular or pulmonary rehabilitation
- Prior revascularization permitted if symptoms are stable and other criteria are met
Exclusion
- Recent change in resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 weeks), or another acute cardiac event
- Unstable angina
- Uncontrolled cardiac arrhythmias
- Symptomatic severe aortic stenosis or other significant valvular disease
- Decompensated symptomatic heart failure
- Acute pulmonary embolism or infarction
- Acute noncardiac disorder likely to interfere with or be worsened by exercise (e.g., infection, thyrotoxicosis)
- Acute myocarditis or pericarditis
- Acute thrombophlebitis
- Physical disability precluding safe or adequate exercise performance
- Significant electrolyte abnormalities
- Clinically significant tachyarrhythmias or bradyarrhythmias
- High-degree atrioventricular block
- Atrial fibrillation with uncontrolled ventricular response
- Hypertrophic obstructive cardiomyopathy with resting left ventricular outflow gradient of \>25 mmHg
- Known active aortic dissection
- Severe resting arterial hypertension (SBP\>200mmHg or DBP \>110 mmHg)
- Mental impairment preventing cooperation with study procedures
- Current pregnancy
- Moderate to severe peripheral neuropathy
- Open wounds or compromised skin near BFR cuff site
- Active DVT or thromboembolic event within the past year
Key Trial Info
Start Date :
November 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 5 2027
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT07223437
Start Date
November 5 2025
End Date
November 5 2027
Last Update
October 31 2025
Active Locations (1)
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1
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920