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Exercise with a blood flow cuff for people with peripheral arterial disease

Tests cuff-assisted exercise training on walking and safety in adults with peripheral arterial disease.

Key facts

Who runs it
University of Tennessee Graduate School of Medicine
Where
Knoxville, United StatesSee the site
Trial code
Registry title
REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center
Status
Recruiting
People taking part
81 people, planned
Started
27 Apr 2026
Expected to end
27 Apr 2027
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Blood Flow Restriction Cuff System
  • Low-load Resistance Training
  • High-load Resistance Training
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with peripheral arterial disease (narrowed leg arteries) and stable leg pain when walking. It tests exercise with blood flow restriction cuffs.

Age
18 years or older
Sex
All sexes
Disease stage
Peripheral arterial disease with stable claudication (leg pain when walking, unchanged for 6 months). People must be able to be referred to cardiovascular or pulmonary rehabilitation.
Earlier treatment
People who had a prior procedure to restore blood flow (revascularization) can join if symptoms are stable and other criteria are met.
Biomarker or test result
Ankle-brachial index (ABI) between 0.4 and 0.9.

Main reasons for not taking part

  • Recent heart attack (within 2 weeks), unstable angina or other acute heart problems
  • Uncontrolled heart rhythm problems or decompensated heart failure
  • Severe resting high blood pressure (SBP>200mmHg or DBP >110 mmHg)
  • Current pregnancy
  • Moderate to severe nerve damage in the limbs, open wounds near the cuff site, or active DVT or a clot event within the past year

The registry criteria, word for word

Show all 27 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 noncardiac disorder likely to interfere with or be worsened by exercise (e.g., infection, thyrotoxicosis)
  • Severe resting arterial hypertension (SBP>200mmHg or DBP >110 mmHg)
  • Mental impairment preventing cooperation with study procedures
  • Acute pulmonary embolism or infarction
  • 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
  • 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

Where in United States

  • University of Tennessee Medical CenterKnoxville, United StatesContact: Morgan Randall, MD (principal investigator)Taking people

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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

The 3 groups in the trial

  • Blood Flow Restriction (BFR) TrainingTreatment being tested

    Participants perform supervised lower-body resistance training using pneumatic cuffs (Smart Cuff Pro or equivalent) applied to the proximal thighs. Cuffs are inflated to 60-80% of the participant's measured arterial occlusion pressure (AOP). Pressure is increased at Weeks 5 and 9 based on tolerance. Cuff inflation will not exceed 80% of limb occlusion pressure. Cuffs will be immediately deflated if participants' vitals suggest poor tolerance.

    Treatment: Blood Flow Restriction Cuff System

  • Low-Load Traditional Resistance Training (LL-RT)Existing treatment, for comparison

    Participants perform the same two calf exercises (seated and standing calf raises) without BFR cuffs. If participants demonstrate the ability to complete all prescribed repetitions without undue strain, planned load progressions of approximately 5-10% 1RM will be introduced at Weeks 5 and 9. Repetitions and sets will remain fixed to match the BFR protocol.

    Treatment: Low-load Resistance Training

  • High-Load Traditional Resistance Training (HL-RT)Existing treatment, for comparison

    Participants in this group will perform seated and standing calf raises following a more conventional strength training model. Similar to the other groups, if participants can complete their prescribed workload without excessive strain, two planned load progressions (5-10% 1RM) will be applied at Weeks 5 and 9. Repetitions and sets will remain fixed to preserve consistency in training structure across groups. This group serves as a benchmark for conventional resistance training in clinical and musculoskeletal rehabilitation populations.

    Treatment: High-load Resistance Training

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center
Plain-language title
Exercise with a blood flow cuff for people with peripheral arterial diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
4 November 2026