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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Cardiac Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehab<br>Patients randomized into early cardiac rehabilitation | Behavioral: Cardiac Rehabilitation<br>* A standard cardiac rehabilitation program consisting of 3 days per week of supervised exercise and education.<br>|
| No Intervention: Control<br>No cardiac rehabilitation until after 6 week post assessment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary fitness | Peak VO2 as measured on a treadmill using gas exchange | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | six weeks |