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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Rehab

Patients randomized into early cardiac rehabilitation

Group Type EXPERIMENTAL

Cardiac Rehabilitation

Intervention Type BEHAVIORAL

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

Control

No cardiac rehabilitation until after 6 week post assessment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cardiac Rehabilitation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No