Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
Study NCT ID:
NCT01584895
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2012-04-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072038', 'term': 'Cardiac Rehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-17', 'studyFirstSubmitDate': '2012-04-23', 'studyFirstSubmitQcDate': '2012-04-24', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiopulmonary fitness', 'timeFrame': 'six weeks', 'description': 'Peak VO2 as measured on a treadmill using gas exchange'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'six weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '24189213', 'type': 'BACKGROUND', 'citation': 'Kerrigan DJ, Williams CT, Ehrman JK, Bronsteen K, Saval MA, Schairer JR, Swaffer M, Keteyian SJ. Muscular strength and cardiorespiratory fitness are associated with health status in patients with recently implanted continuous-flow LVADs. J Cardiopulm Rehabil Prev. 2013 Nov-Dec;33(6):396-400. doi: 10.1097/HCR.0000000000000024.'}, {'pmid': '25447348', 'type': 'RESULT', 'citation': 'Kerrigan DJ, Williams CT, Ehrman JK, Saval MA, Bronsteen K, Schairer JR, Swaffer M, Brawner CA, Lanfear DE, Selektor Y, Velez M, Tita C, Keteyian SJ. Cardiac rehabilitation improves functional capacity and patient-reported health status in patients with continuous-flow left ventricular assist devices: the Rehab-VAD randomized controlled trial. JACC Heart Fail. 2014 Dec;2(6):653-9. doi: 10.1016/j.jchf.2014.06.011. Epub 2014 Oct 22.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPurpose: 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.\n\nMethods: 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.\n\nFollowing 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.\n\nAt 6 weeks after randomization both groups will again undergo fitness assessments and retake the quality of life questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Continuous flow left ventricular assist device\n* Implanted within the past six months\n* Approval from cardiologist to participate in cardiac rehabilitation\n* Age greater or equal to 18 years\n* No history of cardiac rehabilitation participation since receiving a LVAD\n\nExclusion Criteria:\n\n* Orthopedic limitations to perform exercise\n* Current infection related to LVAD\n* Severe anemia\n* Recent CVA related to LVAD implant that affects ability to exercise\n* Unable to attend cardiac rehabilitation at Henry Ford Hospital\n* Uncontrolled metabolic disorders'}, 'identificationModule': {'nctId': 'NCT01584895', 'acronym': 'RehabVAD', 'briefTitle': 'Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial', 'orgStudyIdInfo': {'id': 'hfhs-pc-RehabVAD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rehab', 'description': 'Patients randomized into early cardiac rehabilitation', 'interventionNames': ['Behavioral: Cardiac Rehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No cardiac rehabilitation until after 6 week post assessment.'}], 'interventions': [{'name': 'Cardiac Rehabilitation', 'type': 'BEHAVIORAL', 'description': 'A standard cardiac rehabilitation program consisting of 3 days per week of supervised exercise and education.', 'armGroupLabels': ['Rehab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Clay Ford Center for Athletic Medicine', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Dennis J Kerrigan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Exercise Physiologist', 'investigatorFullName': 'Dennis J. Kerrigan', 'investigatorAffiliation': 'Henry Ford Health System'}}}}