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

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

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Behavioral: Blood Flow Restriction Cuff System; Behavioral: Low-load Resistance Training; Behavioral: High-load Resistance Training

• Study Type: Interventional
• Enrollment (Estimated): 81
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tiffany Johnson, Study Coordinator; Phone Number: +1865-305-4682; Email: thjohnson@utmck.edu

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • University of Tennessee Medical Center
      • Principal Investigator: Morgan Randall, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 set of 30 repetitions, followed by 3 sets of 15 repetitions; 30 seconds rest between sets, with the cuff remaining inflated; Load set at 20-35% of 1RM; Cuff deflated immediately after the fourth set or after 6 continuous minutes of inflation, whichever comes first
Active Comparator: 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.	Behavioral: Low-load Resistance Training; Two resistance exercises (seated and standing calf raises) using the same repetition structure; 1 set of 30 repetitions, followed by 3 sets of 15 repetitions; Load set at 20-35% of 1RM; 30 seconds rest between sets; No BFR cuffs will be used
Active Comparator: 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.	Behavioral: High-load Resistance Training; Each session includes: 3 sets of 8-12 repetitions; Load set at 60-70% of 1RM; Rest periods of 60-90 seconds between sets; No BFR cuffs will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Claudication Onset Time (COT) during 6MWT	Time to onset of claudication symptoms during 6MWT at baseline, post-intervention, and 3-month follow-up	Baseline, post-intervention (8 to 12 weeks), and 3 months post-intervention
Ratings of Perceived Exertion (RPE), Dyspnea, and Claudication Pain	Session-based self-reported symptom ratings collected at each supervised exercise session from Visit 2 to end of intervention (approximately 8 to 12 weeks). These ratings assess exercise tolerance and symptom burden during blood flow restriction training.	Multiple assessments from Visit 2 through end of intervention (approximately 8 to 12 weeks)
Adverse Event (AE) and Serious Adverse Event (SAE) Rates	Number and rate of adverse events and serious adverse events occurring during the study period.	Baseline to 3-month follow-up
Enrollment, Retention, and Adherence Rates	Rates of successful enrollment, participant retention at post-intervention and 3-month follow-up, and adherence to prescribed exercise sessions	Baseline to 3-month follow-up

Collaborators and Investigators

• Sponsor: University of Tennessee Graduate School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2026
• Primary Completion (Estimated): April 27, 2027
• Study Completion (Estimated): April 27, 2027

Study Registration Dates

• First Submitted: October 24, 2025
• First Submitted That Met QC Criteria: October 28, 2025
• First Posted (Actual): October 31, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 5460; Institutional Review Board (Other Identifier: The University of Tennessee Health Science Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No