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Completed

NCT Number: NCT01584895

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

William Clay Ford Center for Athletic Medicine

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac rehabilitation

Behavioral

A standard cardiac rehabilitation program consisting of 3 days per week of supervised exercise and education.

Primary outcomes

  1. Cardiopulmonary fitness

    Time frame: six weeks

    Peak VO2 as measured on a treadmill using gas exchange

Secondary outcomes

  1. Quality of life

    Time frame: six weeks

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Acronym: RehabVAD

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Apr 25, 2012
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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