Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-02-26 @ 5:46 AM
Study NCT ID:
NCT03628508
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2018-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Muscle Property, Alignment and Joint Loading in People With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amy.fu@polyu.edu.hk', 'phone': '8522766 6726', 'title': 'Dr Amy Fu', 'organization': 'The Hong Kong Polytechnic University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks since start of exercise program 1 year after finishing the exercise program', 'eventGroups': [{'id': 'EG000', 'title': 'Exercise', 'description': 'Six-week exercise including stretching, strengthening, endurance and gait modification\n\nExercise: Comprehensive exercise program including strengthening, stretching, gait modification etc.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of External Knee Adduction Moment as Assessed by Visual Motion Analysis System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise', 'description': 'Six-week exercise including stretching, strengthening, endurance and gait modification\n\nExercise: Comprehensive exercise program including strengthening, stretching, gait modification etc.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'spread': '0.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and one week after intervention', 'description': 'External knee moment in the frontal plane during early stance phase of walking', 'unitOfMeasure': 'Nm/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change of Pain Severity Score as Assessed by Knee Injury and Osteoarthritis Outcome Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise', 'description': 'Six-week exercise including stretching, strengthening, endurance and gait modification\n\nExercise: Comprehensive exercise program including strengthening, stretching, gait modification etc.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and one week after intervention', 'description': 'Pain intensity measured by the pain subscale of Knee injury and Osteoarthritis Outcome Score (KOOS). The minimum value is 0 and maximum value is 100. The higher scores mean a better outcome.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tibial Torsion as Assessed by X-ray Imaging', 'timeFrame': 'At baseline', 'description': 'The angle between tibial and femur in the transverse plane', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': "Change of Young's Modulus of Quadriceps as Assessed by Ultrasound Elastography", 'timeFrame': 'At baseline and one week after intervention', 'description': "Young's modulus by ultrasound elastography", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exercise', 'description': 'Six-week exercise including stretching, strengthening, endurance and gait modification\n\nExercise: Comprehensive exercise program including strengthening, stretching, gait modification etc.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Exercise', 'description': 'Six-week exercise including stretching, strengthening, endurance and gait modification\n\nExercise: Comprehensive exercise program including strengthening, stretching, gait modification etc.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '63', 'spread': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hong Kong', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-27', 'size': 117853, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-24T22:53', 'hasProtocol': True}, {'date': '2020-07-27', 'size': 277165, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-02-24T22:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2018-08-06', 'resultsFirstSubmitDate': '2020-11-25', 'studyFirstSubmitQcDate': '2018-08-09', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-01', 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of External Knee Adduction Moment as Assessed by Visual Motion Analysis System', 'timeFrame': 'At baseline and one week after intervention', 'description': 'External knee moment in the frontal plane during early stance phase of walking'}], 'secondaryOutcomes': [{'measure': 'Change of Pain Severity Score as Assessed by Knee Injury and Osteoarthritis Outcome Score', 'timeFrame': 'At baseline and one week after intervention', 'description': 'Pain intensity measured by the pain subscale of Knee injury and Osteoarthritis Outcome Score (KOOS). The minimum value is 0 and maximum value is 100. The higher scores mean a better outcome.'}, {'measure': 'Tibial Torsion as Assessed by X-ray Imaging', 'timeFrame': 'At baseline', 'description': 'The angle between tibial and femur in the transverse plane'}, {'measure': "Change of Young's Modulus of Quadriceps as Assessed by Ultrasound Elastography", 'timeFrame': 'At baseline and one week after intervention', 'description': "Young's modulus by ultrasound elastography"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['muscle tension', 'alignment', 'knee osteoarthritis', 'loading'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'Knee osteoarthritis (KOA) is a common chronic painful musculoskeletal condition among older adults. It poses great challenge to the health care system due to its inability to be cured. Understanding factors associated with disease progression in KOA should assist the development of novel prevention/rehabilitation strategies. This study investigate factors including muscle properties, lower limb alignment and joint loading in patients with knee osteoarthritis before and after a six-week exercise program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 50-80\n2. having radiographic tibiofemoral joint OA in the medial compartment defined as Kellgren and Lawrence grade = 2 to 3\n3. having medial knee pain on most days of the month\n4. having a minimum average pain score of 2 on an 11-point numerical rating scale in the past week while walking\n\nExclusion Criteria:\n\n1. having lateral tibiofemoral compartment osteophytes greater than the medial side.\n2. having undergone intra-articular corticosteroid injection or knee surgery to either knee within the past 3 months\n3. having a systemic arthritic condition (e.g., rheumatoid arthritis)\n4. having a knee joint replacement or high tibial osteotomy in the past\n5. having any other muscular, joint or neurological condition influencing lower limb function\n6. unable to walk unaided\n7. having low back, hip, ankle or foot pain \\> 3 on numerical rating scale\n8. having a body mass index (BMI) \\>36 kg/ m2'}, 'identificationModule': {'nctId': 'NCT03628508', 'briefTitle': 'Muscle Property, Alignment and Joint Loading in People With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'External Tibia Torsion and Passive Muscle Stiffness of Quadriceps as Two Important Contributors of Joint Loading During Walking in People With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'HSEARS20170406003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'Six-week exercise including stretching, strengthening, endurance and gait modification', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Comprehensive exercise program including strengthening, stretching, gait modification etc.', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Siu Ngor Fu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Queen Mary Hospital, Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}