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

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01584895

Run by

Henry Ford Health System

People needed

26

Starts

2011-05-01

Expected to finish

2013-01-01

Last updated by the study team

2015-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• William Clay Ford Center for Athletic Medicine — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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