Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial (RehabVAD)
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|ClinicalTrials.gov Identifier: NCT01584895|
Recruitment Status : Completed
First Posted : April 25, 2012
Last Update Posted : August 19, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Behavioral: Cardiac Rehabilitation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||January 2013|
Patients randomized into early cardiac rehabilitation
Behavioral: Cardiac Rehabilitation
A standard cardiac rehabilitation program consisting of 3 days per week of supervised exercise and education.
No Intervention: Control
No cardiac rehabilitation until after 6 week post assessment.
- Cardiopulmonary fitness [ Time Frame: six weeks ]Peak VO2 as measured on a treadmill using gas exchange
- Quality of life [ Time Frame: six weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584895
|United States, Michigan|
|William Clay Ford Center for Athletic Medicine|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Dennis J Kerrigan, PhD||Henry Ford Health System|