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

Обзор

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

Вмешательства

• Поведенческое 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
• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

• Walking Function [Срок оценки: Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF)]
• Quality of Life (QoL) (1) [Срок оценки: Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF)]
• Quality of Life (QoL) (2) [Срок оценки: Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF)]
• Quality of Life (QoL) (3) [Срок оценки: Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF)]

Вторичные конечные точки (4)

• Claudication Onset Time (COT) during 6MWT [Срок оценки: Baseline, post-intervention (8 to 12 weeks), and 3 months post-intervention]
• Ratings of Perceived Exertion (RPE), Dyspnea, and Claudication Pain [Срок оценки: Multiple assessments from Visit 2 through end of intervention (approximately 8 to 12 weeks)]
• Adverse Event (AE) and Serious Adverse Event (SAE) Rates [Срок оценки: Baseline to 3-month follow-up]
• Enrollment, Retention, and Adherence Rates [Срок оценки: Baseline to 3-month follow-up]

Критерии участия

Критерии включения

• 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
• Prior revascularization permitted if symptoms are stable and other criteria are met

Критерии исключения

• 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
• Known active aortic dissection
• Severe resting arterial hypertension (SBP>200mmHg or DBP >110 mmHg)
• Mental impairment preventing cooperation with study procedures
• Current pregnancy
• Moderate to severe peripheral neuropathy
• Open wounds or compromised skin near BFR cuff site
• Active DVT or thromboembolic event within the past year

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Tennessee Medical Center — Knoxville

Идентификаторы

NCT: NCT07223437 · 5460 · Institutional Review Board

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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