Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT04680793
Status:
COMPLETED
Last Update Posted:
2022-07-22
First Post:
2020-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a Multidisciplinary Outpatient Rehabilitation Program in Patients With Ehlers-Danlos Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004535', 'term': 'Ehlers-Danlos Syndrome'}], 'ancestors': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients are assessed 9 weeks before the start of the program, at the beginning and at the end of the program, and 6 weeks and 6 months after the end of the program. The 9-week period before the program is used as a control condition. It is of the same duration as the program, which also lasts 9 weeks. Patients are asked not to change their lifestyle during the 9-week period before the rehabilitation program.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2020-12-16', 'studyFirstSubmitQcDate': '2020-12-18', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance covered in the 6-minute walk test', 'timeFrame': '9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months'}], 'secondaryOutcomes': [{'measure': 'Other data from the 6-minute walk test', 'timeFrame': '9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months'}, {'measure': 'Time of an endurance test on a cyclo-ergometer', 'timeFrame': 'Baseline ; 9 weeks'}, {'measure': 'Area swept by the gravity center during a balance test on a posturological platform', 'timeFrame': '9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months', 'description': 'Four balance tests : bipodal with eyes open, bipodal with eyes closed and unipodal with eyes open on the two sides'}, {'measure': 'Tampa scale for kinesiophobia (questionnaire)', 'timeFrame': '9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months'}, {'measure': 'Brief pain inventory (questionnaire)', 'timeFrame': '9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months'}, {'measure': 'Nijmegen questionnaire', 'timeFrame': '9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months'}, {'measure': 'Multidimensional fatigue inventory (questionnaire)', 'timeFrame': '9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months'}, {'measure': 'Medical outcome study short form 36 (questionnaire)', 'timeFrame': '9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months'}, {'measure': 'Hospital anxiety and depression scale (questionnaire)', 'timeFrame': '9 weeks before baseline ; Baseline ; 9 weeks ; 15 weeks ; 8 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rehabilitation; Ehlers-Danlos syndrome; Quality of life; Physical capacity'], 'conditions': ['Ehlers-Danlos Syndrome']}, 'referencesModule': {'references': [{'pmid': '37406924', 'type': 'DERIVED', 'citation': 'Hakimi A, Bergoin C, De Jesus A, Hoorelbeke A, Ramon P, Florea O, Fabre C, Mucci P. Multiple Sustainable Benefits of a Rehabilitation Program in Therapeutic Management of Hypermobile Ehlers-Danlos Syndrome: A Prospective and Controlled Study at Short- and Medium-Term. Arch Phys Med Rehabil. 2023 Dec;104(12):2059-2066. doi: 10.1016/j.apmr.2023.06.012. Epub 2023 Jul 4.'}, {'pmid': '35941284', 'type': 'DERIVED', 'citation': 'Hakimi A, Bergoin C, Mucci P. Evidence of ventilatory constraints during exercise in hypermobile Ehlers-Danlos syndrome. Eur J Appl Physiol. 2022 Nov;122(11):2367-2374. doi: 10.1007/s00421-022-05017-y. Epub 2022 Aug 8.'}]}, 'descriptionModule': {'briefSummary': "The management of patients with Ehlers-Danlos syndrome (EDS) is still underdeveloped in healthcare institutions in France. Although multidisciplinary management through exercise rehabilitation has demonstrated its benefits in many chronic pathologies, it has not been evaluated for EDS. As a result, to date there is no evidence of its effectiveness in patients with EDS. The objective of this study is therefore to objectively evaluate the effectiveness of such a treatment on the different dimensions of these patients' health."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* EDS diagnosis.\n* Inclusion in the rehabilitation program.\n\nExclusion Criteria:\n\n* Absolute and relative cardio-vascular contraindications to rehabilitation.\n* Other contraindications to exercise.\n* Psychological contraindication (Beck questionnaire score ≥ 20)'}, 'identificationModule': {'nctId': 'NCT04680793', 'briefTitle': 'Effects of a Multidisciplinary Outpatient Rehabilitation Program in Patients With Ehlers-Danlos Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'Clinique de la Mitterie'}, 'officialTitle': 'Effects of a Multidisciplinary Outpatient Rehabilitation Program on Physical Capacity and Quality of Life in Patients With Ehlers-Danlos Syndrome.', 'orgStudyIdInfo': {'id': '2019-A02154-53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'EDS Patients', 'description': 'No intervention during the control period (9 weeks) and then experimental during the rehabilitation stage (9 weeks).', 'interventionNames': ['Other: Rehabilitation']}], 'interventions': [{'name': 'Rehabilitation', 'type': 'OTHER', 'description': "The program takes place over a total period of 9 weeks: for 4 weeks they will be cared for two days a week, then after a week's break, for 4 weeks they will be cared for three days a week for a total of approximately 80 hours of care. The program is multidisciplinary and includes: balneotherapy, ergometry, occupational therapy, gymnastics, physiotherapy, walking, sophrology, yoga as well as different workshops for the therapeutic education of the patient led by several professionals (dieticians, physiotherapists, doctors, psychologists).", 'armGroupLabels': ['EDS Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59160', 'city': 'Lomme', 'country': 'France', 'facility': 'Clinique de la Mitterie', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}], 'overallOfficials': [{'name': 'Patrick MUCCI, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'URePSSS'}, {'name': 'Cyrille BERGOIN, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique de la Mitterie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hakimi Adrien', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Hakimi Adrien', 'investigatorAffiliation': 'Clinique de la Mitterie'}}}}