Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-01 @ 7:39 AM
Study NCT ID:
NCT02004756
Status:
TERMINATED
Last Update Posted:
2016-02-01
First Post:
2013-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'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': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Feasibility issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-29', 'studyFirstSubmitDate': '2013-08-25', 'studyFirstSubmitQcDate': '2013-12-02', 'lastUpdatePostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac and skeletal function and metabolism', 'timeFrame': '1 day', 'description': 'Blood oxygen level dependent functional magnetic resonance imaging (BOLD fMRI), and 31P-MRS will allow for the precise measurement of cardiac and musculoskeletal function, circulatory perfusion and vascular reactivity, and aerobic and anaerobic metabolism, respectively. Cardiac function will be examined via MRI and exercise echocardiography.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediatric', 'fontan', 'congenital heart disease', 'cardiac and musculoskeletal funion', 'cardiac and/or musculoskeletal metabolism', 'exercise training intervention'], 'conditions': ['Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': 'Primary Objective: To determine if impairments in cardiac and musculoskeletal function and metabolism exist in Fontan children.\n\nSecondary Objectives:\n\n1. To determine if impairments do exist, are they related to exercise capacity.\n2. To determine if a 12-week exercise training intervention improves cardiac and/or musculoskeletal metabolism.\n\nHypothesis: The investigators hypothesize that abnormalities in cardiac and skeletal function are evident, influence exercise capacity, and can be improved with exercise training.', 'detailedDescription': 'This proposed research provides an interdisciplinary approach to understanding exercise intolerance by examining cardiac and musculoskeletal metabolism in a unique cohort of children with congenital heart disease. Study findings may more importantly lead to evidence-based exercise interventions that promote improvements in overall physical health, quality of life, and functional status for Fontan children. Furthermore, this pilot study will lead to the development of a novel research protocol which may be applied to larger Fontan and other congenital heart disease cohorts. This study will also provide preliminary data to develop and conduct a larger clinical research project.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFontan Patients:\n\n1. Patients who have had the Fontan cardiac procedure\n2. 10-16 years of age\n3. Written Informed Consent\n\nHealthy Controls:\n\n1. 10 - 16 years of age\n2. Written Informed Consent\n\nExclusion Criteria:\n\nFontan Patients:\n\n1. Contraindication to exercise\n2. Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005)\n3. Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos)\n4. Patients with a known allergy to gadolinium.\n5. Patients with a history of allergic disposition or have anaphylactic reactions\n6. Moderate-to-severe renal impairment (defined as having a GFR/ eGFR \\< 60 mL/min)\n7. Have Sickle Cell anemia\n8. Known pregnancy, or breast feeding\n9. Patient is uncooperative during a MRI without sedation or anesthesia\n\nHealthy Controls:\n\n1. Contraindication to exercise\n2. Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005)\n3. Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos, pregnancy)\n4. Patient is uncooperative during a MRI without sedation or anesthesia'}, 'identificationModule': {'nctId': 'NCT02004756', 'briefTitle': 'Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function in Children After the Fontan Procedure', 'orgStudyIdInfo': {'id': '1000016650'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fontan Patients', 'description': 'Fontan patients who are monitored at the Hospital for Sick Children (SickKids) will undergo an exercise program', 'interventionNames': ['Other: Exercise Program']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy Controls', 'description': 'Healthy age-matched adolescents'}], 'interventions': [{'name': 'Exercise Program', 'type': 'OTHER', 'description': 'The Fontan cohort will subsequently complete a 12-week moderate intensity exercise intervention whereby individualized activity-based home interventions will be prescribed (i.e., sample activities: walking, jogging, swimming, cycling, soccer). More specifically, individualized weekly exercise programs for participants will be provided incorporating two specific exercise components.', 'armGroupLabels': ['Fontan Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5V1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Brian McCrindle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Cardiologist', 'investigatorFullName': 'Brian McCrindle', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}