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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01584895
Acronym
RehabVAD
Enrollment
26
Registered
2012-04-25
Start date
2011-05-31
Completion date
2013-01-31
Last updated
2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

BEHAVIORALCardiac Rehabilitation

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

Sponsors

Henry Ford Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Cardiopulmonary fitnesssix weeksPeak VO2 as measured on a treadmill using gas exchange

Secondary

MeasureTime frame
Quality of lifesix weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026