Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-09 @ 11:02 PM
Study NCT ID:
NCT03167502
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2017-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance in Walking in Osteoarthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2017-05-24', 'studyFirstSubmitQcDate': '2017-05-24', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Walking performance', 'timeFrame': 'after 6 training weeks', 'description': '6-minute walk test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '35832351', 'type': 'DERIVED', 'citation': 'Trojani MC, Chorin F, Gerus P, Breuil V, Michel C, Guis S, Bendahan D, Roux C. Concentric or eccentric physical activity for patients with symptomatic osteoarthritis of the knee: a randomized prospective study. Ther Adv Musculoskelet Dis. 2022 Jul 7;14:1759720X221102805. doi: 10.1177/1759720X221102805. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Few data exist to date on the effect of eccentric muscle building in knee osteoarthritis. No studies have compared the effect of eccentric versus concentric reinforcement in knee osteoarthritis. Our study aims to show the effectiveness of an eccentric reinforcement. This is a randomized, interventional trial.', 'detailedDescription': 'Few data exist to date on the effect of eccentric muscle building in knee osteoarthritis. No studies have compared the effect of eccentric versus concentric reinforcement in knee osteoarthritis. Our study aims to show the effectiveness of an eccentric reinforcement, the interest of a work supervised by a sports coach to maintain activity over time and to study the effect of this activity at the muscular level. The main objective is to study the effect of an eccentric muscle strengthening program on walking performance in osteoarthritis patients. The secondary objectives are to study: the effect of fatigue on walking, the relationship between fatigue and the level of physical activity, the effect of training on perceived fatigue and the effect of training on the function and at muscular level. This is a randomized, interventional trial. 40 subjects are planned. Inclusion criteria include: age 40-85 years, KL 2 and 3. The subjects are divided into two groups to perform either eccentric or concentric work. 2 sessions per week for 6 weeks. At baseline and at the end of the study a clinical evaluation and MRI will be carried out for evaluation of the criteria of judgment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Autonomous subjects aged 40 to 85\n* Subjects meeting ACR criteria for gonarthrosis\n* Subjects with a score of Kellgren and Lawrence at least one knee greater than or equal to 2\n* Signature of consent form\n* Subjects affiliated to social security\n\nExclusion Criteria:\n\nSubject with a Kellgren and Lawrence stadium at 4 for at least one of his two knees\n\n* Subjects with symptomatic femoro-patellar arthrosis\n* Subject with a pathology that makes walking testing impossible.\n* Non-autonomous subjects, with a pathology impairing walking\n* Subjects with symptomatic osteoarthritis of the hip and / or with a hip or knee prosthesis\n* Subject incapable of signing consent and unable to understand information leaflet.'}, 'identificationModule': {'nctId': 'NCT03167502', 'acronym': 'EX-ART', 'briefTitle': 'Performance in Walking in Osteoarthritis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Performance in Walking in Osteoarthritis Patients: the Role of Fatigue and the Effect of an Eccentric Muscle Building Program', 'orgStudyIdInfo': {'id': '16-AOIP-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'concentric work', 'description': 'patient suffering from knee osteoarthritis will follow a concentric work. This training is 2 sessions per week for 6 weeks', 'interventionNames': ['Other: concentric work']}, {'type': 'EXPERIMENTAL', 'label': 'eccentric work', 'description': 'patient suffering from knee osteoarthritis will follow an eccentric work. This training is 2 sessions per week for 6 weeks', 'interventionNames': ['Other: eccentric work']}], 'interventions': [{'name': 'eccentric work', 'type': 'OTHER', 'description': 'patient will follow 2 eccentric trainings per week during 6 weeks', 'armGroupLabels': ['eccentric work']}, {'name': 'concentric work', 'type': 'OTHER', 'description': 'patient will follow 2 concentric trainings per week during 6 weeks', 'armGroupLabels': ['concentric work']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Department of rheumatology, nice university hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Christian H ROUX, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'service de Rhumatologie, CHU de NICE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}