Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:47 PM
Study NCT ID:
NCT01822769
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2013-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2013-03-28', 'studyFirstSubmitQcDate': '2013-03-28', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in peak cardiac output and its components (SV/HR)', 'timeFrame': 'Baseline to 3 months (primary)'}, {'measure': 'Mechanism of change in peak VO2', 'timeFrame': 'Baseline to 3 months (primary)', 'description': 'Cardiac output will be assessed and O2 delivery/extraction will be estimated to define mechanisms of improvement in exercise capacity.'}, {'measure': 'Change in ventilatory efficiency', 'timeFrame': 'Baseline to 3 months (primary)'}, {'measure': 'Change in strength (dynamometry)', 'timeFrame': 'Baseline to 3 months (primary)'}, {'measure': 'Change in pulse wave velocity', 'timeFrame': 'Baseline to 3 months'}, {'measure': 'Change in circulating biomarkers', 'timeFrame': 'Baseline to 3 months (primary)'}, {'measure': 'Change in markers of pulse reflection', 'timeFrame': 'Baseline to 3 months'}, {'measure': 'Incidence of arrhythmia and other adverse events during cardiopulmonary rehabilitation', 'timeFrame': 'Baseline to 3 months'}, {'measure': 'Change in physical activity', 'timeFrame': 'Baseline to 3 months', 'description': 'Survey and accelerometry'}, {'measure': 'Change in markers of ventricular function', 'timeFrame': 'Baseline to 3 months'}], 'primaryOutcomes': [{'measure': 'Change in aerobic exercise capacity (peak VO2)', 'timeFrame': 'Baseline to 3 months (primary)'}], 'secondaryOutcomes': [{'measure': 'Change in quality of life measurement', 'timeFrame': 'Baseline to 3 months (primary)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['congenital heart disease', 'adult congenital heart disease', 'cardiac rehabilitation', 'cardiopulmonary rehabilitation', 'exercise', 'cardiopulmonary exercise testing', 'peak vO2', 'quality of life'], 'conditions': ['Congenital Heart Disease', 'Heart Defects, Congenital']}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that participation in a formal cardiopulmonary rehabilitation program improves aerobic exercise capacity and quality of life over the medium term for patients with congenital heart disease with reduced exercise capacity. To test this hypothesis, subjects will be randomized to either receive a 12-week cardiopulmonary rehabilitation program or standard of care, with interval testing of aerobic capacity and other physiologic markers improved fitness, as well as assessment of quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able and willing to participate in a 12-week cardiac rehabilitation program and repeated cardiopulmonary exercise testing\n* pVO2≤80% predicted (impaired aerobic capacity) on baseline exercise test\n* congenital heart disease of at least moderate complexity\n\nExclusion Criteria:\n\n* Cardiac intervention (cath/surg) within prior 6m\n* Planned cardiac intervention (cath/surg) within 12m\n* Formal cardiac rehabilitation within 24m\n* Current/recent (delivery\\<90d prior) pregnancy, planned pregnancy within 12m\n* Active heart failure, hospitalization or major change in clinical status over prior 30d\n* Other recent or planned events expected to have a significant impact on exercise capacity\n* Baseline oxygen saturation \\<92%'}, 'identificationModule': {'nctId': 'NCT01822769', 'briefTitle': 'Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease', 'orgStudyIdInfo': {'id': 'P00005391'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cardiopulmonary rehabilitation', 'description': 'The subjects will attend 2 sessions each week for 12 weeks. Each session will be approximately 2 hours in duration, consisting of both exercise (aerobic and strength,\\~60 minutes) and education. In addition, subjects will be directed to participate in 3 weekly \\~40 minute home exercise training sessions, personalized to their level of aerobic conditioning.', 'interventionNames': ['Other: Cardiopulmonary rehabilitation']}, {'type': 'OTHER', 'label': 'Standard of care', 'description': 'Subjects randomized to standard of care will not be enrolled in a rehabilitation program, but may receive any other clinically indicated exercise training or other intervention (e.g., an exercise prescription).', 'interventionNames': ['Other: Standard of care']}], 'interventions': [{'name': 'Cardiopulmonary rehabilitation', 'type': 'OTHER', 'description': 'See Arm Description', 'armGroupLabels': ['Cardiopulmonary rehabilitation']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': 'See Arm Description', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Alexander Opotowsky', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital, Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Alexander Opotowsky', 'investigatorAffiliation': "Boston Children's Hospital"}}}}