Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-05 @ 5:07 PM
Study NCT ID:
NCT02295605
Status:
COMPLETED
Last Update Posted:
2016-08-02
First Post:
2014-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Land-based and Water-based Exercises for Knee Osteoarthritis: Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-31', 'studyFirstSubmitDate': '2014-11-08', 'studyFirstSubmitQcDate': '2014-11-17', 'lastUpdatePostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Function', 'timeFrame': '8 weeks', 'description': 'Pain and Function scores on the Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC questionnaire)'}], 'secondaryOutcomes': [{'measure': 'Physical Performance', 'timeFrame': '8 weeks', 'description': 'Physical Performance scores on the Timed Up and GO test (TUG)'}, {'measure': 'Strength muscle', 'timeFrame': '8 weeks', 'description': 'Strength muscle scores measured by heldheld dynamometer'}, {'measure': 'Lower Limbs Function', 'timeFrame': '8 weeks', 'description': 'Function Scores on the Lower Extremity Functional Scale (LEFS)'}, {'measure': 'Pain', 'timeFrame': '8 weeks', 'description': 'Pain Scores on the Numeric Pain Rating Scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Forty six patients with knee osteoarthritis will be randomly allocated into two groups: water-based exercises and land-based exercises. Both of them will receive a strengthening exercise protocol for lower limb muscles. A blind investigator will assess the patients before and immediately after, 3 months and 6 months following the interventions. The main outcomes will be pain, function and strength.', 'detailedDescription': 'Forty six patients with knee osteoarthritis will be randomly allocated into two groups: water-based exercises and land-based exercises. Both of them will receive a strengthening exercise protocol for lower limb muscles. A blind investigator will assess the patients before and immediately after, 3 months and 6 months following the interventions. The main outcomes will be pain, function, physical performance and strength.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate knee osteoarthritis (grade 2 or 3 using the Kellgren-Lawrence radiograph classification), diagnosed based on clinical and radiological criteria of the American College of Rheumatology\n* No other lower limb and spine musculoskeletal disorders\n* Independent gait\n* Body mass index below 32\n* Minimum of 4 points in the pain numeric rating scale during climb and descend stairs activities\n\nExclusion Criteria:\n\n* Cognitive or psychological disorders\n* Neurological disorders\n* History of post-traumatic knee osteoarthritis\n* Knee pain at least 12 months\n* Prior surgery of the lower limbs or spine\n* Fibromyalgia\n* Rheumatoid arthritis\n* Cardiovascular disease\n* Participating in exercise programs and received treatment for the knee at least 3 months'}, 'identificationModule': {'nctId': 'NCT02295605', 'briefTitle': 'Comparison Between Land-based and Water-based Exercises for Knee Osteoarthritis: Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Nove de Julho'}, 'officialTitle': 'Comparison Between a Land-based and Water-based Muscles Strengthening Program on Patients With Knee Osteoarthritis Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'University of Nove de Julho'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Land-based exercises', 'description': 'Land-based muscle strengthening exercises protocol', 'interventionNames': ['Other: land-based exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Water-based exercises', 'description': 'Water-based muscle strengthening exercises protocol', 'interventionNames': ['Other: water-based exercises']}], 'interventions': [{'name': 'water-based exercises', 'type': 'OTHER', 'description': 'water-based exercise strengthening protocol for lower limb muscles', 'armGroupLabels': ['Water-based exercises']}, {'name': 'land-based exercises', 'type': 'OTHER', 'description': 'land-based exercise strengthening protocol for lower limb muscles', 'armGroupLabels': ['Land-based exercises']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Nove de Julho', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'José Geraldo S Morelli, PhD student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nove de Julho'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nove de Julho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'André Serra Bley', 'investigatorAffiliation': 'University of Nove de Julho'}}}}