Actively Recruiting
REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center
Led by University of Tennessee Graduate School of Medicine · Updated on 2026-04-29
81
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosed peripheral arterial disease with stable claudication symptoms unchanged for 6 months
- Ankle-brachial index (ABI) between 0.4 and 0.9
- Eligible referral to cardiovascular or pulmonary rehabilitation
- Prior revascularization allowed if symptoms are stable and criteria are met
You will not qualify if you...
- Recent changes in resting ECG suggesting significant ischemia, recent myocardial infarction within 2 weeks, or other acute cardiac events
- 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 disorders likely to interfere with or worsen with exercise (e.g., infection, thyrotoxicosis)
- Acute myocarditis or pericarditis
- Acute thrombophlebitis
- Physical disability preventing safe or adequate exercise
- 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 >25 mmHg
- Known active aortic dissection
- Severe resting arterial hypertension (SBP >200 mmHg or DBP >110 mmHg)
- Mental impairment preventing cooperation
- Current pregnancy
- Moderate to severe peripheral neuropathy
- Open wounds or compromised skin near BFR cuff site
- Active deep vein thrombosis or thromboembolic event within the past year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Actively Recruiting
Research Team
T
Tiffany Johnson, Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here