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

NCT07223437 | Recruiting

• 2 other identifiers: 5460Institutional Review Board
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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. 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. 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. 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

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (4)

• Walking Function

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

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

• Quality of Life (QoL) (1)

  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

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

• Quality of Life (QoL) (2)

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

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

• Quality of Life (QoL) (3)

  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

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

Secondary Outcomes (4)

• Claudication Onset Time (COT) during 6MWT

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

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

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

• Adverse Event (AE) and Serious Adverse Event (SAE) Rates

  Baseline to 3-month follow-up

• Enrollment, Retention, and Adherence Rates

  Baseline to 3-month follow-up

Study Arms (3)

Blood Flow Restriction (BFR) Training

EXPERIMENTAL

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.

Behavioral: Blood Flow Restriction Cuff System

Low-Load Traditional Resistance Training (LL-RT)

ACTIVE COMPARATOR

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.

Behavioral: Low-load Resistance Training

High-Load Traditional Resistance Training (HL-RT)

ACTIVE COMPARATOR

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.

Behavioral: High-load Resistance Training

Interventions

Low-load Resistance Training BEHAVIORAL

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

Low-Load Traditional Resistance Training (LL-RT)

High-load Resistance Training BEHAVIORAL

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

High-Load Traditional Resistance Training (HL-RT)

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. 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

Blood Flow Restriction (BFR) Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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
• 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

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Tiffany Johnson, Study Coordinator

CONTACT

+1865-305-4682; thjohnson@utmck.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2025
• First Posted: October 31, 2025
• Study Start: April 27, 2026
• Primary Completion (Estimated): April 27, 2027
• Study Completion (Estimated): April 27, 2027
• Last Updated: April 29, 2026

Record last verified: 2025-10

Locations

US (1)