Ignite Creation Date:
2024-05-06 @ 12:28 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01584895
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2012-04-23
Brief Title:
Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist DevicesRehab VAD Trial
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist DevicesRehab VAD Trial
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RehabVAD
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 ie 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None