Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT04325334
Status:
COMPLETED
Last Update Posted:
2025-03-25
First Post:
2020-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteoarthritis Running & Cartilage Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-30', 'size': 302189, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-25T17:46', 'hasProtocol': True}, {'date': '2019-11-30', 'size': 199347, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-25T17:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Both runners with and without knee osteoarthritis will be recruited. They will all receive the same intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2020-03-25', 'studyFirstSubmitQcDate': '2020-03-26', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline to 12 weeks in T2 relaxation time of the medial femoral cartilage', 'timeFrame': 'Baseline, 12 weeks', 'description': 'T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. This constant is assessed using MRI.'}, {'measure': 'Change from Baseline to 12 weeks in T2 relaxation time of the medial tibial cartilage', 'timeFrame': 'Baseline, 12 weeks', 'description': 'T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. This constant is assessed using MRI.'}, {'measure': 'Change from Baseline to 12 weeks in T2 relaxation time of the lateral femoral cartilage', 'timeFrame': 'Baseline, 12 weeks', 'description': 'T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. This constant is assessed using MRI.'}, {'measure': 'Change from Baseline to 12 weeks in T2 relaxation time of the lateral tibial cartilage', 'timeFrame': 'Baseline, 12 weeks', 'description': 'T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. This constant is assessed using MRI.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline to 12 weeks in T1ρ relaxation time of the medial femoral cartilage', 'timeFrame': 'Baseline, 12 weeks', 'description': 'T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.'}, {'measure': 'Change from Baseline to 12 weeks in T1ρ relaxation time of the medial tibial cartilage', 'timeFrame': 'Baseline, 12 weeks', 'description': 'T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.'}, {'measure': 'Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral femoral cartilage', 'timeFrame': 'Baseline, 12 weeks', 'description': 'T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.'}, {'measure': 'Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral tibial cartilage', 'timeFrame': 'Baseline, 12 weeks', 'description': 'T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.'}, {'measure': 'Change from Baseline to 12 weeks in knee joint loading: peak knee adduction moment', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.'}, {'measure': 'Change from Baseline to 12 weeks in knee joint loading: knee adduction moment impulse', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.'}, {'measure': 'Change from Baseline to 12 weeks in knee joint loading: peak flexion moment', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.'}, {'measure': 'Change from Baseline to 12 weeks in knee joint loading: flexion moment impulse', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.'}, {'measure': 'Change from Baseline to 12 weeks in knee joint kinematics: peak knee flexion angle', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.'}, {'measure': 'Change from Baseline to 12 weeks in knee joint kinematics: knee joint angle excursion', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.'}, {'measure': 'Change from Baseline to 12 weeks in foot strike pattern', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.'}, {'measure': 'Change from Baseline to 12 weeks in step rate', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.'}, {'measure': 'Change from Baseline to 12 weeks in knee symptoms: Knee Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Validated questionnaire on symptoms and functional limitations related to knee osteoarthritis. The score is expressed in percentage (0-100), with 0 representing extreme knee problems and 100 representing no knee problems.'}, {'measure': 'Change from Baseline to 12 weeks in knee symptoms: Visual Analog Scale', 'timeFrame': 'Baseline to 12 weeks, averaged weekly', 'description': 'Knee pain during and after running will be assessed for each training. The minimum value is "No Pain" and the maximum value is "Worst Pain Imaginable". Each week of training will be averaged.'}, {'measure': 'Change from Baseline to 12 weeks in weekly running distance', 'timeFrame': 'Baseline to 12 weeks, averaged weekly', 'description': 'Participants will record their weekly running distance using an online diary.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoarthritis', 'knee', 'running', 'magnetic resonance imaging', 'MRI'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'Knee osteoarthritis (OA) is a debilitating disease affecting millions of Canadians. Exercise is a core treatment for knee OA, and is advocated by all clinical guidelines. However, the safety of recreational running in the presence of knee OA is unclear. There are no studies available to provide direct data to appropriately inform runners and clinicians whether running should be advocated for joint health. Our research study will address this gap.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nALL:\n\n* aged greater than 40 years\n* recreational runners who run at least twice per week for a total of at least 10 km, and have done so for a minimum of 12 months\n* comfortable running on a treadmill for 30 minutes.\n\nTFOA Group:\n\n* exhibit radiographic evidence of mild or moderate tibiofemoral osteoarthritis (TFOA) according to the Kellgren and Lawrence OA classification scale (grade ≥ 2)\n* report knee pain on most days of the previous 3 months (during running and activities of daily living).\n\nControl Group:\n\n* free of any radiographic signs of TFOA according to the Kellgren and Lawrence scale (grade = 0)\n* pain free in both knees for the 12 months prior to recruitment.\n\nExclusion Criteria:\n\nALL:\n\n* any history of traumatic knee injury (fracture, severe sprain, meniscus injury)\n* presence of an inflammatory arthritic condition\n* presence of any health condition (other than OA in the TFOA group) affecting normal movement or precludes engaging in moderate to high impact activities such as running\n* use of any oral or injected corticosteroids or viscosupplementation in the previous 6 months\n* any history of surgery in either knee\n* standard contra-indications to magnetic resonance imaging (MRI).'}, 'identificationModule': {'nctId': 'NCT04325334', 'acronym': 'ORCA', 'briefTitle': 'Osteoarthritis Running & Cartilage Assessment', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Linking Biomechanical and Imaging Outcomes to Better Understand the Effects of Running on Knee Joint Health', 'orgStudyIdInfo': {'id': 'H19-01806'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Running volume increase', 'description': 'Participants will be be given a running program based on their running mileage on inclusion and supported by regular contacts with the study trainer.', 'interventionNames': ['Behavioral: Running volume increase']}], 'interventions': [{'name': 'Running volume increase', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a 12-week running program to increase their running volume by approximately 10% per week on average, and in accordance with the "10% rule" advocated to minimize injury rates. For the purpose of this study, participants will run using their habitual technique - i.e. no specific instructions on \'how\' to run will be provided; rather, they will simply be instructed on \'how much\' to run.', 'armGroupLabels': ['Running volume increase']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6T 1Z3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Motion Analysis and Biofeedback Laboratory, The University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Michael A Hunt, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Michael Hunt', 'investigatorAffiliation': 'University of British Columbia'}}}}