Viewing Study NCT00917618


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Study NCT ID: NCT00917618
Status: COMPLETED
Last Update Posted: 2017-10-17
First Post: 2009-06-09
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: The Effects of Group Cycling (Spinning®) With Knee Osteoarthritis: A Randomized Control Trial
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-13', 'studyFirstSubmitDate': '2009-06-09', 'studyFirstSubmitQcDate': '2009-06-09', 'lastUpdatePostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preferred gait speed', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'WOMAC', 'timeFrame': '12 weeks'}, {'measure': 'KOS', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoarthritis', 'knee', 'exercise', 'cycling'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '22951360', 'type': 'DERIVED', 'citation': 'Salacinski AJ, Krohn K, Lewis SF, Holland ML, Ireland K, Marchetti G. The effects of group cycling on gait and pain-related disability in individuals with mild-to-moderate knee osteoarthritis: a randomized controlled trial. J Orthop Sports Phys Ther. 2012 Dec;42(12):985-95. doi: 10.2519/jospt.2012.3813. Epub 2012 Aug 2.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: Group cycling classes (Spinning®) will improve pain and functional outcomes in patients with knee osteoarthritis\n\nMethods: Patients with symptomatic knee OA will be randomized to active Spinning® classes 2-3 per week or control group for 3 months. Outcomes including gait speed, WOMAC, KOOS, KOS, and VAS pain at rest and after 6 min walk will be performed at baseline and at 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic and radiographic knee OA\n\nExclusion Criteria:\n\n* severe patella femoral knee pain that would make cycling difficult\n* medical condition which would prohibit an exercise program'}, 'identificationModule': {'nctId': 'NCT00917618', 'briefTitle': 'The Effects of Group Cycling (Spinning®) With Knee Osteoarthritis: A Randomized Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'The Effects of Group Cycling (Spinning®) On Gait and Pain-Related Disability in Persons With Knee Osteoarthritis: A Randomized Control Trial', 'orgStudyIdInfo': {'id': '0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise intervention', 'description': 'Patients began the exercise intervention after randomization for 12 weeks', 'interventionNames': ['Other: Exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Patients were asked not to change their baseline exercise program', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Patients randomized to treatment arm attended 2-3 Spinning classes per week for 12 weeks.', 'armGroupLabels': ['Exercise intervention']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Patients randomized to the control arm were instructed not to change their baseline exercise programs', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15219', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mercy Hospital of Pittsbugh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Kelly Krohn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mercy Hospital of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mercy Hospital, Pittsburgh, PA', 'class': 'OTHER'}, 'collaborators': [{'name': 'PNC Band arthritis research fund', 'class': 'UNKNOWN'}, {'name': 'Mad Dogg Athletics', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}