Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial (RehabVAD)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac Rehabilitation
Sponsored by

About this trial
This is an interventional supportive care trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
- William Clay Ford Center for Athletic Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rehab
Control
Arm Description
Patients randomized into early cardiac rehabilitation
No cardiac rehabilitation until after 6 week post assessment.
Outcomes
Primary Outcome Measures
Cardiopulmonary fitness
Peak VO2 as measured on a treadmill using gas exchange
Secondary Outcome Measures
Quality of life
Full Information
NCT ID
NCT01584895
First Posted
April 23, 2012
Last Updated
August 17, 2015
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT01584895
Brief Title
Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial
Acronym
RehabVAD
Official Title
Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rehab
Arm Type
Experimental
Arm Description
Patients randomized into early cardiac rehabilitation
Arm Title
Control
Arm Type
No Intervention
Arm Description
No cardiac rehabilitation until after 6 week post assessment.
Intervention Type
Behavioral
Intervention Name(s)
Cardiac Rehabilitation
Intervention Description
A standard cardiac rehabilitation program consisting of 3 days per week of supervised exercise and education.
Primary Outcome Measure Information:
Title
Cardiopulmonary fitness
Description
Peak VO2 as measured on a treadmill using gas exchange
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis J Kerrigan, PhD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Clay Ford Center for Athletic Medicine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24189213
Citation
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.
Results Reference
background
PubMed Identifier
25447348
Citation
Kerrigan 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.
Results Reference
result
Learn more about this trial
Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial
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