Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Cardiopulmonary fitness
研究概览
简要总结
Cardiac rehabilitation programs improve mortality, functional capacity, and quality of life, for a variety of patients with heart disease. It stands to reason that patients with LVADs might therefore also benefit from the same structured exercise training, education, and clinical surveillance. One potential benefit of cardiac rehabilitation in this patient population is reversal of the skeletal muscle atrophy that occurs due to extended periods of poor peripheral perfusion (i.e. before implantation) and prolonged sedentary behavior.
Purpose: The purpose of this proposed study is to examine the effects of a 6-week exercise program on cardiorespiratory fitness, quality of life, and device flow rate in patients with recently implanted LVADs.
Methods: 30 patients with recently implanted LVADs will be referred by the Henry Ford Hospital Advanced Heart Failure Program once the patient is deemed appropriate for exercise. Before enrollment into cardiac rehabilitation patients will undergo a six minute walk test and graded exercise stress test on a treadmill to determine exercise capacity. Additionally, a quality of life questionnaire will be given.
Following the stress test, patients will be randomized (2 to 1 ratio) into either cardiac rehabilitation or control. Those chosen to be in the control group will be encouraged to maintain daily activities; those in the rehabilitation group will partake in 6 weeks of a standard cardiac rehabilitation program. This will consist of 3 days a week of supervised exercise as well as education regarding diet and lifestyle modifications.
At 6 weeks after randomization both groups will again undergo fitness assessments and retake the quality of life questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Continuous flow left ventricular assist device
- •Implanted within the past six months
- •Approval from cardiologist to participate in cardiac rehabilitation
- •Age greater or equal to 18 years
- •No history of cardiac rehabilitation participation since receiving a LVAD
排除标准
- •Orthopedic limitations to perform exercise
- •Current infection related to LVAD
- •Severe anemia
- •Recent CVA related to LVAD implant that affects ability to exercise
- •Unable to attend cardiac rehabilitation at Henry Ford Hospital
- •Uncontrolled metabolic disorders
结局指标
主要结局
Cardiopulmonary fitness
时间窗: six weeks
Peak VO2 as measured on a treadmill using gas exchange
次要结局
- Quality of life(six weeks)
研究者
Dennis J. Kerrigan
Senior Exercise Physiologist
Henry Ford Health System
