REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center
NCT ID: NCT07223437
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
81 participants
INTERVENTIONAL
2025-11-05
2027-11-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Blood Flow Restriction (BFR) Training
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.
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
Low-Load Traditional Resistance Training (LL-RT)
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.
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
High-Load Traditional Resistance Training (HL-RT)
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Tennessee Graduate School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Institutional Review Board
Identifier Type: OTHER
Identifier Source: secondary_id
5460
Identifier Type: -
Identifier Source: org_study_id