Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-01-22 @ 10:12 AM
Study NCT ID:
NCT02584192
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
2015-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Early Home-based Cardiac Rehabilitation Program for Patients After Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-21', 'studyFirstSubmitDate': '2015-10-16', 'studyFirstSubmitQcDate': '2015-10-21', 'lastUpdatePostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'myocardial function using the three-dimensional speckle tracking echocardiography (3D-STE)', 'timeFrame': 'Change from baseline strain parameters at four-week follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '34741536', 'type': 'DERIVED', 'citation': 'Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the effect of this CR program on the improvement of myocardial function using the three-dimensional speckle tracking echocardiography (3D-STE) in AMI patients.', 'detailedDescription': 'The effect of early short-term home-based cardiac rehabilitation (CR) program on left ventricular function in acute myocardial infarction (AMI) patients is not clear yet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being aged 18-65 years with a confirmed AMI diagnosis\n* Being suitable for the CR program\n* Undergoing PCI at the entry\n\nExclusion Criteria:\n\n* Known ischemic heart disease, heart valvular lesions, intra-ventricular conduction disturbances, malignant arrhythmia, cardiac shock, and poor echocardiographic conditions to take STE examination'}, 'identificationModule': {'nctId': 'NCT02584192', 'briefTitle': 'Efficacy of Early Home-based Cardiac Rehabilitation Program for Patients After Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou General Hospital of Guangzhou Military Command'}, 'officialTitle': 'Efficacy of Early Home-based Cardiac Rehabilitation Program for Patients After Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'CR2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the rehabilitation group', 'description': 'entailing an early home-based CR program', 'interventionNames': ['Behavioral: entailing an early home-based CR program']}, {'type': 'OTHER', 'label': 'the control group', 'description': 'enter the usual care program, including the importance of carrying out physical activity, which was performed during inpatient care.', 'interventionNames': ['Other: enter the usual care program']}], 'interventions': [{'name': 'entailing an early home-based CR program', 'type': 'BEHAVIORAL', 'description': 'enter the early outpatient phase of CR program. The progressive exercise training of this phase was performed without supervision after their discharge. The CR program consisted of a five-minute warm-up period (stretching), a twenty-minute aerobic exercise (walking or trotting, gymnastics), and a five-minute cooling-down period (stretching)', 'armGroupLabels': ['the rehabilitation group']}, {'name': 'enter the usual care program', 'type': 'OTHER', 'description': 'enter the usual care program, including the importance of carrying out physical activity, which was performed during inpatient care.', 'armGroupLabels': ['the control group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lin Xu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Lin Xu', 'investigatorAffiliation': 'Guangzhou General Hospital of Guangzhou Military Command'}}}}