Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial
RehabVAD
1 other identifier
interventional
26
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started May 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 23, 2012
CompletedFirst Posted
Study publicly available on registry
April 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedAugust 19, 2015
August 1, 2015
1.3 years
April 23, 2012
August 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Cardiopulmonary fitness
Peak VO2 as measured on a treadmill using gas exchange
six weeks
Secondary Outcomes (1)
Quality of life
six weeks
Study Arms (2)
Rehab
EXPERIMENTALPatients randomized into early cardiac rehabilitation
Control
NO INTERVENTIONNo cardiac rehabilitation until after 6 week post assessment.
Interventions
A standard cardiac rehabilitation program consisting of 3 days per week of supervised exercise and education.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
William Clay Ford Center for Athletic Medicine
Detroit, Michigan, 48202, United States
Related Publications (2)
Kerrigan DJ, Williams CT, Ehrman JK, Bronsteen K, Saval MA, Schairer JR, Swaffer M, Keteyian SJ. Muscular strength and cardiorespiratory fitness are associated with health status in patients with recently implanted continuous-flow LVADs. J Cardiopulm Rehabil Prev. 2013 Nov-Dec;33(6):396-400. doi: 10.1097/HCR.0000000000000024.
PMID: 24189213BACKGROUNDKerrigan DJ, Williams CT, Ehrman JK, Saval MA, Bronsteen K, Schairer JR, Swaffer M, Brawner CA, Lanfear DE, Selektor Y, Velez M, Tita C, Keteyian SJ. Cardiac rehabilitation improves functional capacity and patient-reported health status in patients with continuous-flow left ventricular assist devices: the Rehab-VAD randomized controlled trial. JACC Heart Fail. 2014 Dec;2(6):653-9. doi: 10.1016/j.jchf.2014.06.011. Epub 2014 Oct 22.
PMID: 25447348RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis J Kerrigan, PhD
Henry Ford Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Exercise Physiologist
Study Record Dates
First Submitted
April 23, 2012
First Posted
April 25, 2012
Study Start
May 1, 2011
Primary Completion
September 1, 2012
Study Completion
January 1, 2013
Last Updated
August 19, 2015
Record last verified: 2015-08