Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial (RehabVAD)
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Purpose
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 | Intervention |
|---|---|
|
Heart Failure |
Behavioral: Cardiac Rehabilitation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial |
- Cardiopulmonary fitness [ Time Frame: six weeks ] [ Designated as safety issue: No ]Peak VO2 as measured on a treadmill using gas exchange
- Quality of life [ Time Frame: six weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rehab
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Matthew Saval, MS | 313-972-4018 | msaval@hfhs.org |
| United States, Michigan | |
| William Clay Ford Center for Athletic Medicine | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Matthew Saval, MS 313-972-4018 msaval@hfhs.org | |
| Principal Investigator: | Dennis J Kerrigan, PhD | Henry Ford Health System |
More Information
No publications provided
| Responsible Party: | Dennis J. Kerrigan, Senior Exercise Physiologist, Henry Ford Health System |
| ClinicalTrials.gov Identifier: | NCT01584895 History of Changes |
| Other Study ID Numbers: | hfhs-pc-RehabVAD |
| Study First Received: | April 23, 2012 |
| Last Updated: | April 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013