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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dennis J. Kerrigan, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01584895
First received: April 23, 2012
Last updated: August 17, 2015
Last verified: August 2015
  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

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Cardiopulmonary fitness [ Time Frame: six weeks ] [ Designated as safety issue: No ]
    Peak VO2 as measured on a treadmill using gas exchange


Secondary Outcome Measures:
  • Quality of life [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: May 2011
Study Completion Date: January 2013
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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584895

Locations
United States, Michigan
William Clay Ford Center for Athletic Medicine
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Dennis J Kerrigan, PhD Henry Ford Health System