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New treatment option for Peripheral Arterial Disease
Official title REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center
ClinicalTrials.gov ID: NCT07223437
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Knoxville, Tennessee, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Knoxville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.