REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Tennessee Graduate School of Medicine
- Enrollment
- 81
- Locations
- 2
- Primary Endpoint
- Walking Function
Overview
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:
- 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
- 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
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 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.
- •Eligible referral to cardiovascular or pulmonary rehabilitation
- •Prior revascularization permitted if symptoms are stable and other criteria are met
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Blood Flow Restriction Cuff System (Behavioral)
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.
Intervention: Low-load Resistance Training (Behavioral)
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.
Intervention: High-load Resistance Training (Behavioral)
Outcomes
Primary Outcomes
Walking Function
Time Frame: Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF)
Change in walking distance measured by the Six-Minute Walk Test (6MWT) from baseline to end of intervention and 3-month follow-up visit.
Quality of Life (QoL) (1)
Time Frame: Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF)
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
Quality of Life (QoL) (2)
Time Frame: Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF)
Change in depressive symptoms as assessed by Patient Health Questionnaire-9 (PHQ-9) from baseline to post-intervention and 3-month follow-up
Quality of Life (QoL) (3)
Time Frame: Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF)
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
Secondary Outcomes
- 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)