Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-02-25 @ 4:39 PM
Study NCT ID:
NCT03690518
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2018-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases
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'}, {'id': 'D001519', 'term': 'Behavior'}], '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': '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': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cardiac rehabilitation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2018-08-07', 'studyFirstSubmitQcDate': '2018-09-27', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life score (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life.', 'timeFrame': 'follow up of patients over 12 months', 'description': 'Evolution of the PedsQL 4.0 self-reported scores from month 0 to month 12'}], 'secondaryOutcomes': [{'measure': 'Peak oxygen uptake (VO2max, ml/kg/min)', 'timeFrame': 'Month 0 and Month 12'}, {'measure': 'ventilatory anaerobic threshold (VAT, ml/kg/min)', 'timeFrame': 'Month 0 and Month 12'}, {'measure': 'knowledge of the disease', 'timeFrame': 'Month 0 and Month 12', 'description': 'Disease knowledge questionnaire (Leuven questionnaire, 34 items, total range score from 0 to 100, a higher score indicating better knowledge)'}, {'measure': 'cardiac events', 'timeFrame': 'Month 0 and Month 12', 'description': 'number of consultation in cardiology, number of hospitalization in cardiology, number of cardiovascular events'}, {'measure': 'physical activity scoring', 'timeFrame': 'Month 0 and Month 12', 'description': 'Score of physical activity (Ricci and Gagnon questionnaire, 9 items, total range score from 6 to 45, higher score indicating a higher level of physical activity)'}, {'measure': 'functional NYHA class', 'timeFrame': 'Month 0 and Month 12', 'description': 'NYHA functional class= New York Association functional class from the World Health Organization'}, {'measure': 'Cardiac output during exercise', 'timeFrame': 'Month 0 and Month12', 'description': 'Variation of cardiac output during exercise tests measured by impedance measurement (Physioflow)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac rehabilitation', 'Congenital heart diseases', 'Heart defects, congenital', 'Adolescent', 'Young adult', 'Physical activity', 'Cardio-pulmonary exercice test', 'Oxygen uptake', 'Muscular deconditioning', 'Patient education as topic', 'Quality of life', 'Health Knowledge, Attitudes, Practice'], 'conditions': ['Heart Defects, Congenital', 'Adolescent', 'Young Adult']}, 'referencesModule': {'references': [{'pmid': '30616811', 'type': 'BACKGROUND', 'citation': 'Amedro P, Gavotto A, Legendre A, Lavastre K, Bredy C, De La Villeon G, Matecki S, Vandenberghe D, Ladeveze M, Bajolle F, Bosser G, Bouvaist H, Brosset P, Cohen L, Cohen S, Corone S, Dauphin C, Dulac Y, Hascoet S, Iriart X, Ladouceur M, Mace L, Neagu OA, Ovaert C, Picot MC, Poirette L, Sidney F, Soullier C, Thambo JB, Combes N, Bonnet D, Guillaumont S. Impact of a centre and home-based cardiac rehabilitation program on the quality of life of teenagers and young adults with congenital heart disease: The QUALI-REHAB study rationale, design and methods. Int J Cardiol. 2019 May 15;283:112-118. doi: 10.1016/j.ijcard.2018.12.050. Epub 2018 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to measure the impact of a rehabilitation program in congenital cardiology in terms of health related quality of life. The orginality of the rehabilitation program consists in its design : initial hospitalizationfor a short period of time (5 days) at the rehabilitation center, followed by 11 weeks of rehabilitation at home under the supervision of a specialized sports trainer.', 'detailedDescription': 'Adolescents and adults with congenital heart disease (CHD) have reduced exercise capacity compared to the general population, even for "simple" heart disease.\n\nRegular physical activity is known to reduce the risk of acquired heart disease.\n\nCardiac rehabilitation programs have been largely developed to manage adult coronary and heart failure patients, which is not yet the case routinely in patients, adults and children, carriers of DC.\n\nThe investigators assume that patients who participate in this program will improve their quality of life compared to controls.\n\nThe orginality of the rehabilitation program consists in its design : initial hospitalizationfor a short period of time (5 days) at the rehabilitation center, followed by 11 weeks of rehabilitation at home under the supervision of a specialized sports trainer .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 13 to 25 years included\n* With a congenital heart diseases (CHD) as defined in the international CHD classification.\n* Recent (\\< 3 months) cardio-pulmonary exercise test (CPET)with maximum oxygen uptake (VO2max) \\<80% of theoretical values and/or first ventilatory anaerovic threshold (VAT) \\<55% of VO2max.\n* Consent of the adult patient or the parents or legal guardians of the minor patient.\n* Beneficiary of the social security scheme.\n\nExclusion Criteria:\n\n* Uncontrolled arrhythmia.\n* Cardiac surgery planned during the rehabilitation program.\n* Severe musculoskeletal disorders.\n* Severe intellectual disability that does not allow the quality of life questionnaire to be completed.\n* Pregnancy.\n* Patient who already underwent cardiac rehabilitation in the last 24 months.\n* All medical contraindications to perform a cardiorespiratory stress test.\n* Uncontrolled heart failure (NYHA IV)\n* Obesity (BMI \\> 30)'}, 'identificationModule': {'nctId': 'NCT03690518', 'acronym': 'QUALIREHAB', 'briefTitle': 'Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Impact of Cardiovascular Rehabilitation on the Quality of Life of Adolescents and Young Adults With Congenital Heart Disease: A Randomized Controlled Multicentre Trial', 'orgStudyIdInfo': {'id': 'RECHMPL18_0039'}, 'secondaryIdInfos': [{'id': '7576', 'type': 'OTHER', 'domain': 'UH Montpellier'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Controls will have a regular follow-up without any intervention (no rehabilitation program)'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rehabilitaiton', 'description': 'Cardiac rehabilitation: Rehabilitation will have a regular follow-up with intervention (rehabilitation program)', 'interventionNames': ['Other: Cardiac rehabilitation']}], 'interventions': [{'name': 'Cardiac rehabilitation', 'type': 'OTHER', 'description': 'Educational/Counseling/Training : Rehabilitation, , cardiovascular rehabilitation in congenital heart disease', 'armGroupLabels': ['Rehabilitaiton']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Haut Lévêques - Bordeaux University Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Brest', 'country': 'France', 'facility': 'Brest University Hospital', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Gabriel Montpied Hospital- Clermont Ferrand University Hospital', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'Grenoble Alpes University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '92350', 'city': 'Le Plessis-Robinson', 'country': 'France', 'facility': 'Marie Lannelongue Hospital', 'geoPoint': {'lat': 48.78889, 'lon': 2.27078}}, {'zip': '87000', 'city': 'Limoges', 'country': 'France', 'facility': 'Children and Mother Hospital - Limoges University Hospital', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'La Timone- Public Assistance - Marseille hospitals', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '91300', 'city': 'Massy', 'country': 'France', 'facility': 'Liberal Cabinet Massy', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}, {'zip': '34 000', 'city': 'Montpellier', 'country': 'France', 'facility': 'Arnaud de Villeneuve - University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nice', 'country': 'France', 'facility': 'Nice University Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30000', 'city': 'Nîmes', 'country': 'France', 'facility': 'Caremeau - Nimes University Hospital', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '34250', 'city': 'Palavas-les-Flots', 'country': 'France', 'facility': 'Saint-Pierre Institute', 'geoPoint': {'lat': 43.52974, 'lon': 3.93043}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Necker - Sick Children Hospital - Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'La Miletrie -Poitier University Hospital', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'Children Hospital - Toulouse University Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'Pasteur Clinic', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Barbois Hospital - Nancy University Hospital', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}