NCT07223437 · University of Tennessee Graduate School of Medicine
REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center
(REVASC-PAD)
What this study 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Blood 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
BEHAVIORAL
Low-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
BEHAVIORAL
High-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
Primary outcome measures
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.
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
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
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Knoxville, Tennessee
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 29, 2026 · Source of record for eligibility and locations