NCT07223437 REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center
| NCT ID | NCT07223437 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Tennessee Graduate School of Medicine |
| Condition | Peripheral Arterial Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2026-04-27 |
| Primary Completion | 2027-04-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 81 participants in total. It began in 2026-04-27 with a primary completion date of 2027-04-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: 1. 18 years of age or older 2. Diagnosed peripheral arterial disease with stable claudication (symptomatic presentation unchanged for 6 months) 3. Ankle-brachial index (ABI) between 0.4 and 0.9. 4. Eligible referral to cardiovascular or pulmonary rehabilitation 5. Prior revascularization permitted if symptoms are stable and other criteria are met Exclusion Criteria: 1. Recent change in resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 weeks), or another acute cardiac event 2. Unstable angina 3. Uncontrolled cardiac arrhythmias 4. Symptomatic severe aortic stenosis or other significant valvular disease 5. Decompensated symptomatic heart failure 6. Acute pulmonary embolism or infarction 7. Acute noncardiac disorder likely to interfere with or be worsened by exercise (e.g., infection, thyrotoxicosis) 8. Acute myocarditis or pericarditis 9. Acute thrombophlebitis 10. Physical disability precluding safe or adequate exercise performance 11. Significant electrolyte abnormalities 12. Clinically significant tachyarrhythmias or bradyarrhythmias 13. High-degree atrioventricular block 14. Atrial fibrillation with uncontrolled ventricular response 15. Hypertrophic obstructive cardiomyopathy with resting left ventricular outflow gradient of \>25 mmHg 16. Known active aortic dissection 17. Severe resting arterial hypertension (SBP\>200mmHg or DBP \>110 mmHg) 18. Mental impairment preventing cooperation with study procedures 19. Current pregnancy 20. Moderate to severe peripheral neuropathy 21. Open wounds or compromised skin near BFR cuff site 22. Active DVT or thromboembolic event within the past year
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07223437 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07223437 currently recruiting?
Yes, NCT07223437 is actively recruiting participants. Contact the research team at thjohnson@utmck.edu for enrollment information.
Where is the NCT07223437 trial being conducted?
This trial is being conducted at Knoxville, United States.
Who is sponsoring the NCT07223437 clinical trial?
NCT07223437 is sponsored by University of Tennessee Graduate School of Medicine. The trial plans to enroll 81 participants.