RecruitingNot ApplicableNCT07223437

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

Sponsor

University of Tennessee Graduate School of Medicine

Enrollment

81 participants

Start Date

Apr 27, 2026

Study Type

INTERVENTIONAL

Conditions

Peripheral Arterial Disease

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria22

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

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Interventions

BEHAVIORALBlood Flow Restriction Cuff System

All BFR resistance sessions will include two standardized lower-extremity exercises: seated calf raises and standing calf raises. Each session will follow this protocol: 1. 1 set of 30 repetitions, followed by 3 sets of 15 repetitions 2. 30 seconds rest between sets, with the cuff remaining inflated 3. Load set at 20-35% of 1RM 4. Cuff deflated immediately after the fourth set or after 6 continuous minutes of inflation, whichever comes first

BEHAVIORALLow-load Resistance Training

Two resistance exercises (seated and standing calf raises) using the same repetition structure 1. 1 set of 30 repetitions, followed by 3 sets of 15 repetitions 2. Load set at 20-35% of 1RM 3. 30 seconds rest between sets 4. No BFR cuffs will be used

BEHAVIORALHigh-load Resistance Training

Each session includes: 1. 3 sets of 8-12 repetitions 2. Load set at 60-70% of 1RM 3. Rest periods of 60-90 seconds between sets 4. No BFR cuffs will be used