Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-31 @ 6:17 PM
Study NCT ID:
NCT02598804
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2015-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of Self Management Program on Changes in Physical Activity Level of Knee Osteoarthritis Patients in Spa Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-22', 'studyFirstSubmitDate': '2015-11-05', 'studyFirstSubmitQcDate': '2015-11-05', 'lastUpdatePostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of physical activity at 3 month, with score on IPAQ Short form', 'timeFrame': 'at 3 months'}], 'secondaryOutcomes': [{'measure': 'Self efficacy at 3 months with score on ASES', 'timeFrame': 'at 3 months'}, {'measure': 'Functional status at 3 months with score on WOMAC', 'timeFrame': 'at 3 months'}, {'measure': 'Fears and beliefs at 3 months with score on KOFBeQ', 'timeFrame': 'at 3 months'}, {'measure': 'Pain at 3 months with score on EVA', 'timeFrame': 'at 3 months'}, {'measure': 'Sarcopenia at 18 days', 'timeFrame': 'at 18 days'}]}, 'conditionsModule': {'keywords': ['Physical activity level', 'Knee osteoarthritis', 'Randomized controlled trials', 'Alternate month design study', 'Self-management', 'Self-care', 'Education and exercise in knee osteoarthritis', 'Education', 'Non pharmacological treatment'], 'conditions': ['Knee Osteoarthritis', 'Physical Activity', 'Education', 'Self-management', 'Exercise']}, 'referencesModule': {'references': [{'pmid': '30326906', 'type': 'DERIVED', 'citation': 'Gay C, Guiguet-Auclair C, Pereira B, Goldstein A, Bareyre L, Coste N, Coudeyre E. Efficacy of self-management exercise program with spa therapy for behavioral management of knee osteoarthritis: research protocol for a quasi-randomized controlled trial (GEET one). BMC Complement Altern Med. 2018 Oct 16;18(1):279. doi: 10.1186/s12906-018-2339-x.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose is to evaluate the benefit of an education action of exercise on the level of physical activity in patients with knee osteoarthritis with the waning of a spa treatment for three weeks, three months after the start of the cure.', 'detailedDescription': 'The aim of this study is to prove the effectiveness of an educational intervention in thermal environment on physical activity level with knee osteoarthritis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients, male or female, aged 50 to 75 years.\n* Patients with knee osteoarthritis clinical criteria of the American College of Rheumatology (ACR)\n* Patient affiliated to a social security scheme (beneficiary entitled)\n* Patient registered spa\n* Patient has given its consent in writing to\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02598804', 'acronym': 'GEET One', 'briefTitle': 'Evaluation of the Effectiveness of Self Management Program on Changes in Physical Activity Level of Knee Osteoarthritis Patients in Spa Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Evaluation of the Effectiveness of Self Management Program on Changes in Physical Activity Level of Knee Osteoarthritis Patients in Spa Therapy', 'orgStudyIdInfo': {'id': 'CHU-251'}, 'secondaryIdInfos': [{'id': '2015-A00831-48', 'type': 'REGISTRY', 'domain': '2015-A00831-48'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'No single group but 2 groups :\n\n* Intervention group (5 educational workshop in addition to spa therapy)\n* Control group (Written information booklet in addition to spa therapy)', 'interventionNames': ['Other: 5 educational workshop']}, {'type': 'OTHER', 'label': 'control group', 'description': 'No single group but 2 groups :\n\n* Intervention group (5 educational workshop in addition to spa therapy)\n* Control group (Written information booklet in addition to spa therapy)', 'interventionNames': ['Other: written information booklet']}], 'interventions': [{'name': '5 educational workshop', 'type': 'OTHER', 'armGroupLabels': ['Intervention group']}, {'name': 'written information booklet', 'type': 'OTHER', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clermont Communauté', 'class': 'OTHER'}, {'name': 'Innovatherm', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}