跳至主要内容
临床试验/NCT01584895
NCT01584895已完成不适用

Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial

Henry Ford Health System2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2011年5月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dennis J. Kerrigan

Senior Exercise Physiologist

Henry Ford Health System

研究点 (2)

Loading locations...

相似试验