Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07223437

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location status: Recruiting

Location contact

Morgan Randall, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Blood Flow Restriction Cuff System

Behavioral

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 set of 30 repetitions, followed by 3 sets of 15 repetitions
  • 30 seconds rest between sets, with the cuff remaining inflated
  • Load set at 20-35% of 1RM
  • Cuff deflated immediately after the fourth set or after 6 continuous minutes of inflation, whichever comes first

Low-Load Resistance Training

Behavioral

Two resistance exercises (seated and standing calf raises) using the same repetition structure

  • 1 set of 30 repetitions, followed by 3 sets of 15 repetitions
  • Load set at 20-35% of 1RM
  • 30 seconds rest between sets
  • No BFR cuffs will be used

High-Load Resistance Training

Behavioral

Each session includes:

  • 3 sets of 8-12 repetitions
  • Load set at 60-70% of 1RM
  • Rest periods of 60-90 seconds between sets
  • No BFR cuffs will be used

Primary outcomes

  1. Walking Function

    Time frame: Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF)

    Change in walking distance measured by the Six-Minute Walk Test (6MWT) from baseline to end of intervention and 3-month follow-up visit.

  2. Quality of Life (QoL) (1)

    Time frame: Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF)

    Change in health-related quality of life as assessed by EuroQol 5-Dimension 5-Level (EQ-5D-5L) from baseline to post-intervention and 3-month follow-up

  3. Quality of Life (QoL) (2)

    Time frame: Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF)

    Change in depressive symptoms as assessed by Patient Health Questionnaire-9 (PHQ-9) from baseline to post-intervention and 3-month follow-up

  4. Quality of Life (QoL) (3)

    Time frame: Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF)

    Change in self-reported walking function and symptom burden assessed by using REVASC-PAD Walking Questionnaire from baseline to post-intervention and 3-month follow-up

Secondary outcomes

  1. Claudication Onset Time (COT) during 6MWT

    Time frame: Baseline, post-intervention (8 to 12 weeks), and 3 months post-intervention

    Time to onset of claudication symptoms during 6MWT at baseline, post-intervention, and 3-month follow-up

  2. Ratings of Perceived Exertion (RPE), Dyspnea, and Claudication Pain

    Time frame: Multiple assessments from Visit 2 through end of intervention (approximately 8 to 12 weeks)

    Session-based self-reported symptom ratings collected at each supervised exercise session from Visit 2 to end of intervention (approximately 8 to 12 weeks). These ratings assess exercise tolerance and symptom burden during blood flow restriction training.

  3. Adverse Event (AE) and Serious Adverse Event (SAE) Rates

    Time frame: Baseline to 3-month follow-up

    Number and rate of adverse events and serious adverse events occurring during the study period.

  4. Enrollment, Retention, and Adherence Rates

    Time frame: Baseline to 3-month follow-up

    Rates of successful enrollment, participant retention at post-intervention and 3-month follow-up, and adherence to prescribed exercise sessions

Study contacts

Contact information is provided by the study sponsor or research team.

Tiffany Johnson, Study Coordinator

CONTACT

[email protected]

+1865-305-4682

Sponsors and collaborators

Lead sponsor

University of Tennessee Graduate School of Medicine

Other

Registry information

Acronym: REVASC-PAD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 31, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.