About this trial
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
Eligibility criteria
Qualifiers
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 0.9.
Eligible referral to cardiovascular or pulmonary rehabilitation
Disqualifiers
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
Trial design
Treatments tested in this trial
- Blood Flow Restriction Cuff System
- Low-load Resistance Training
- High-load Resistance Training