NCT03251391已完成不适用
To Assess the Safety and Feasibility of a Structured Cardiac Rehabilitation Program in Patients With Peripheral Arterial Disease After Successful Revascularization Procedures: A Pilot Study.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in 6 minute walk test
研究概览
简要总结
The main purpose of this study is to see if it is safe and feasible to use cardiac rehabilitation (CR) in patients with peripheral arterial disease (PAD) after successful revascularization. This study will also test if CR improves quality of life and health outcomes in PAD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients with PAD post-revascularization (stent, angioplasty, or bypass).
- •Patients must have the ability to ambulate safely without assistance and should not have plans for undergoing further staged revascularization procedures.
排除标准
- •Below or above the knee amputation.
- •Underlying cardiopulmonary or other co-morbidity that would be an exclusion under currently approved standard CR protocols at the University of Kansas Medical Center (KUMC).
- •Unfavorable short term prognosis and limited life expectancy (<2 years)
- •Awaiting a planned staged revascularization in same or other leg (patients will be eligible once no further procedures are planned).
- •Prior history of having dropped out of CR without completing.
- •Unwilling to consent for all aspects of CR or study participation.
- •Unable to come for CR (this will exclude patients who live far away or have no means to travel to the CR facility).
- •Pregnancy
研究组 & 干预措施
Cardiac Rehabilitation Group
Experimental
Participants randomized to this group will undergo cardiac rehabilitation program.
干预措施: Cardiac Rehabilitation Program (Other)
Control Group
Active Comparator
Participants randomized to this group will receive care for their condition, conventional therapy, that they would normally receive.
干预措施: Conventional Therapy (Other)
结局指标
主要结局
Change in 6 minute walk test
时间窗: Change from Baseline to Up to 6 Months
Results will be measured in meters.
次要结局
- Short Form Health Survey 36 (SF-36)(Change from Baseline to Week 18)
- Vascular Quality of Life Questionnaire-6 (VascuQol6)(Change from Baseline to Week 18)
- Absolute Claudication Distance (ACD)(Change from Baseline to Up to 6 Months)
- Functional Claudication Distance (FCD)(Change from Baseline to Up to 6 Months)
研究者
研究点 (2)
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