Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT03999320
Status:
COMPLETED
Last Update Posted:
2023-10-03
First Post:
2019-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sophrology and Congenital Heart Disease
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-02', 'studyFirstSubmitDate': '2019-06-24', 'studyFirstSubmitQcDate': '2019-06-24', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum oxygen uptake (VO2 max)', 'timeFrame': 'Variation between Baseline (M0) and at 12 months (M12)', 'description': 'VO2max Variation'}], 'secondaryOutcomes': [{'measure': 'Quality of life score', 'timeFrame': 'Evolution of the PedsQL 4.0 self-reported scores from month 0 to month 12', 'description': 'Quality of life score variation (PedsQL, 24 items), range score from 0 to 100, higher score indicating better quality of life.'}, {'measure': 'Physical activity score', 'timeFrame': 'Variation between Baseline (M0) and at 12 months (M12)', '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Heart Disease']}, 'referencesModule': {'references': [{'pmid': '32154361', 'type': 'BACKGROUND', 'citation': 'Moreau J, Lavastre K, Romieu H, Charbonnier F, Guillaumont S, Bredy C, Abassi H, Werner O, De La Villeon G, Requirand A, Auer A, Matecki S, Karsenty C, Guitarte A, Hadeed K, Dulac Y, Souletie N, Acar P, Bajolle F, Bonnet D, Negre-Pages L, Mura T, Mounier M, Seguela PE, Thomas J, Iriart X, Jean-Benoit-Thambo, Amedro P. Impact of Sophrology on cardiopulmonary fitness in teenagers and young adults with a congenital heart disease: The SOPHROCARE study rationale, design and methods. Int J Cardiol Heart Vasc. 2020 Mar 3;27:100489. doi: 10.1016/j.ijcha.2020.100489. eCollection 2020 Apr.'}], 'seeAlsoLinks': [{'url': 'http://creativecommons.org/licenses/by/4.0/', 'label': 'Impact of Sophrology on cardiopulmonary fitness in teenagers and'}]}, 'descriptionModule': {'briefSummary': 'The SOPHRO-CARE trial aims to measure the impact of sophrology on exercise capacity of adolescents and young adults with congenital heart disease.\n\nInvestigator hypothesized that a series of group sessions of sophrology may improve the exercise capacity, in this population.', 'detailedDescription': 'Adolescents and adults with congenital heart disease (CHD) have reduced exercise capacity compared to the general population.\n\nOur recent randomized trial in a population of children and adolescents with asthma showed that sophrology improve lung function (NCT02114398). Sophrology, from the Greek "study of consciousness in harmony", is an adjuvant therapy, considered in healthcare as a relaxation technique, mainly based on breathing.\n\nInvestigator assume that adolescents and young adults (13-25 y.o.) with CHD who participate in a program of sophrology with structured group sessions will improve their exercise capacity as measured by the maximum oxygen uptake (VO2max), in comparison with a control group.'}, '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 old\n* With a congenital heart disease (CHD) as defined in the international anatomic and clinical classification (ACC) - CHD classification.\n* Informed consent from adult patients or parents/legal guardians for minor patients\n\nExclusion Criteria:\n\n* Medical contraindication to perform an exercise test.\n* Patient already included in a clinical trial.\n* Cardiac surgery planned during the study\n* Severe intellectual disability that does not allow practice of sophrology exercise or questionnaires to be completed .'}, 'identificationModule': {'nctId': 'NCT03999320', 'acronym': 'SOPHRO CARE', 'briefTitle': 'Sophrology and Congenital Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Impact of Sophrology on Exercise Capacity of Adolescents and Young Adults With Congenital Heart Disease : Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RECHMPL18_0043'}, 'secondaryIdInfos': [{'id': 'UF7590', 'type': 'OTHER', 'domain': 'UH Montpellier'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sophrology group', 'description': '8 sophrology sessions, approximately 60 minutes each, spread over 12 months', 'interventionNames': ['Other: Sophrology sessions']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'usual care', 'interventionNames': ['Other: usual care']}], 'interventions': [{'name': 'Sophrology sessions', 'type': 'OTHER', 'description': '8 sophrology sessions, approximately 60 minutes each, spread over 12 months', 'armGroupLabels': ['Sophrology group']}, {'name': 'usual care', 'type': 'OTHER', 'description': 'usual care', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34095', 'city': 'Montpellier', 'state': 'Occitanie', 'country': 'France', 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34250', 'city': 'Palavas-les-Flots', 'country': 'France', 'facility': 'Institut Saint-Pierre', 'geoPoint': {'lat': 43.52974, 'lon': 3.93043}}], 'overallOfficials': [{'name': 'Pascal AMEDRO, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH Montpellier'}, {'name': 'Sophie GUILLAUMONT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Pierre Institut'}, {'name': 'Yves DULAC, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH Toulouse'}, {'name': 'Damien BONNET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP Necker'}, {'name': 'Alban Louen BARUTEAU, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH Nantes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}