REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Walking Function
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: High-load Resistance Training (Behavioral)
结局指标
主要结局
Walking Function
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
次要结局
- 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)