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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01584895
Recruitment Status : Completed
First Posted : April 25, 2012
Last Update Posted : August 19, 2015
Information provided by (Responsible Party):
Dennis J. Kerrigan, Henry Ford Health System

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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Cardiac Rehabilitation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Cardiopulmonary fitness [ Time Frame: six weeks ]
    Peak VO2 as measured on a treadmill using gas exchange

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: six weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01584895

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