Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01584895 · ClinicalTrials.gov registry record · NA
Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial
A NA study, sponsored by Henry Ford Health System.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
NCT01584895: Completed NA study, sponsored by Henry Ford Health System.
NCT01584895 is a NA study that has completed, run by Henry Ford Health System. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01584895, a NA study, has completed, sponsored by Henry Ford Health System.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
Study 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.
Primary Outcome
Peak VO2 as measured on a treadmill using gas exchange
Interventions
- BEHAVIORAL Cardiac Rehabilitation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-01 |
| Phase | NA |
What the finished NCT01584895 record still lists
NCT01584895 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Cardiac Rehabilitation is the first listed.
NCT01584895 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01584895 about?
NCT01584895 is a clinical study titled "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 p...
What is the current status of trial NCT01584895?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2011-05. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01584895?
The interventions under investigation include: Cardiac Rehabilitation (BEHAVIORAL).
Who is sponsoring clinical trial NCT01584895?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01584895's enrollment target sits among peer trials
26 1710th of 2000 higher than 289 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02646475 · 26 participants · Phase 1
Metabolic Effects of Angiotensin-(1-7)
- NCT03603223 · 26 participants · Phase 2
Pembrolizumab in Treating Participants With Leukoplakia
- NCT04063592 · 26 participants · NA
AMI Construction in Lower Extremity Residual Limbs
- NCT04906460 · 26 participants · Phase 1
Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia