NCT07223437

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: University of Tennessee Graduate School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-05
• Primary completion: 2027-11-05
• Completion: 2027-11-05
• First posted: 2025-10-31
• Last updated: 2025-10-31

Locations

1 site across 1 country: United States