Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-27 @ 4:07 PM
Study NCT ID:
NCT03801460
Status:
UNKNOWN
Last Update Posted:
2021-01-13
First Post:
2019-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcomes assessed in a blinded manner'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, multicenter, randomized trial with objective end points assessment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-11', 'studyFirstSubmitDate': '2019-01-09', 'studyFirstSubmitQcDate': '2019-01-09', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life (QOL)', 'timeFrame': 'One year', 'description': "Quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQE is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. KCCQ responses are provided along a rating scale continuum with equal spacing from worst to best."}], 'secondaryOutcomes': [{'measure': 'LOS', 'timeFrame': 'Index hospitalization', 'description': 'Length of stay post TAVR'}, {'measure': 'MACE', 'timeFrame': 'one year', 'description': 'Composite of mortality and repeat hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frailty', 'Transcatheter Aortic Valve Replacement', 'Rehabilitation']}, 'referencesModule': {'references': [{'pmid': '33962483', 'type': 'DERIVED', 'citation': 'Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The PREPARE TAVR pilot study will examine the effects of remotely administered physiological reconditioning program (RAPR) on quality of life (QOL) and clinical outcomes at one year post TAVR in frail older adults.', 'detailedDescription': 'The main objective of this study is to evaluate the effects of a home based exercise and dietary intervention program on the quality of life (QOL) and clinical outcomes in frail adults undergoing Transcatheter aortic valve replacement (TAVR) procedures. Patients will be randomly (1:1) assigned to the standard of care (SOC group) where patients will receive all medical care as decided by their treating physicians or assigned to a home based program known as remotely administered physiological reconditioning (RPR) program which will include receiving personalized instructions for a progressive exercise program and dietary changes. Patients will be contacted for regular phone and in-person follow up for monitoring their progress. The primary endpoint will be quality of life as assessed by KCCQE questionnaires at one-year post TAVR. The secondary endpoints include length of stay post TAVR, all-cause mortality, repeat hospitalization and a composite of all-cause mortality and repeat hospitalization at one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Short Physical Performance Battery Protocol (SPPB) score \\< 9\n\nExclusion Criteria:\n\n* Severe liver disease defined by Childs Pugh class \\>B or MELD score \\>15.\n* Severe kidney disease defined by eGFR \\<30 mL/min.\n* Hospital admission during the 4 weeks prior to randomization.\n* Montreal objective cognitive assessment (MOCA) score \\<18.\n* Mechanical fall in the past month.\n* Unstable angina during the previous month.\n* Myocardial infarction during the previous month.\n* Unsuccessful completion of the one-week run-in phase.\n* Syncopal episode during exercise during run-in phase'}, 'identificationModule': {'nctId': 'NCT03801460', 'acronym': 'PREPARE-TAVR', 'briefTitle': 'Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement Pilot Study', 'orgStudyIdInfo': {'id': 'AC201810'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'SOC', 'description': 'Standard of Care'}, {'type': 'EXPERIMENTAL', 'label': 'RAPR', 'description': 'Remotely administered physiological reconditioning program', 'interventionNames': ['Other: Remotely administered physiological reconditioning program']}], 'interventions': [{'name': 'Remotely administered physiological reconditioning program', 'type': 'OTHER', 'description': 'Patients assigned to intervention arm will be provided a personalized, tailored and graduated exercise program to improve physical strength and conditioning.', 'armGroupLabels': ['RAPR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Newmarket', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Asim Cheema, MD', 'role': 'CONTACT', 'email': 'acheema@southlakeregional.org', 'phone': '416-620-9600'}], 'facility': 'Southlake Hospital', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}], 'centralContacts': [{'name': 'Syed Ishba', 'role': 'CONTACT', 'email': 'ishba.syed@unityhealth.to', 'phone': '416-620-9600'}], 'overallOfficials': [{'name': 'Asim Cheema, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}