Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07223437

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

University of Tennessee Medical Center

Knoxville, Tennessee, United States, 37920

Actively Recruiting

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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

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