Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-02 @ 2:25 AM
Study NCT ID:
NCT06444932
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-06
First Post:
2024-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SUPPLEMENTARY EFFECTS OF RESISTANCE TRAINING IN ADDITION TO JOINT MOBILIZATION IN PERSONS WITH KNEE OSTEOARTHRITIS
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double arm parallel design RCT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-06-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2024-05-27', 'studyFirstSubmitQcDate': '2024-06-05', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Walking related performance fatigability', 'timeFrame': '4 weeks', 'description': 'Walking related performance fatigability will be measured using 6 minute walk test. Greater fatigability indicates poorer outcome.'}, {'measure': 'Stride Length', 'timeFrame': '4 weeks', 'description': 'Gait analysis will be done to analyze stride length. A greater stride length signifies positive outcome and prognosis.'}, {'measure': 'Gait velocity', 'timeFrame': '4 weeks', 'description': 'Gait analysis will be done to analyze gaot velocity. A greater gait velocity signifies positive outcome and prognosis.'}, {'measure': 'Knee Pain', 'timeFrame': '4 weeks', 'description': 'Knee Pain will be measured using visual analogue scale (VAS) from 0-100mm. A higher score on VAS indicated greater pain.'}, {'measure': 'Knee range of motion', 'timeFrame': '4 weeks', 'description': 'Knee range of motion will be measured using a goniometer. A higher ROM signifies positive outcome.'}, {'measure': 'Functional Disability', 'timeFrame': '4 weeks', 'description': 'Knee functional disability will be assessed using Knee Osteoarthritis and Outcome Score (KOOS) with a score ranging from 0-100. A lower score on KOOS signifies greater functional disability.'}, {'measure': 'Isometric Muscle Strength', 'timeFrame': '4 weeks', 'description': 'Isometric Muscle Strength will be quantified using dynamometer. A higher score on dynamometer signifies greater muscle strength and good prognosis.'}, {'measure': 'Functional capacity', 'timeFrame': '4 weeks', 'description': '5 repetition sit to stand test will be used to determine knee related functional capacity, which will be quantified in terms of time. A smaller time will denote greater functional capacity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Joint mobilization and resistance exercise training are effective conservative treatment options for the management of osteoarthritis. However, currently no study has highlighted the supplementary effects of resistance training in addition to joint mobilization in people suffering from knee osteoarthritis. The current study is aimed at bridging the gap in literature and providing evidence regarding the additive impact of resistance training to joint mobilization in knee osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Knee OA grade I-III\n* Individuals of either gender aged 40-70 years\n* Knee OA history of no less than 3 months\n* Knee pain no more than 8/10 cm on the visual analogue scale (VAS)\n* Radiological evidence of grade III or less on Kellgren classification.\n\nExclusion Criteria:\n\n* Those with signs of serious pathology such as malignancy, inflammatory disorder or infection.\n* History of trauma or fractures in lower extremity\n* Signs of lumbar radiculopathy or myelopathy\n* History of knee surgery or replacement and/or receiving intra-articular steroid therapy in the preceding two months'}, 'identificationModule': {'nctId': 'NCT06444932', 'briefTitle': 'SUPPLEMENTARY EFFECTS OF RESISTANCE TRAINING IN ADDITION TO JOINT MOBILIZATION IN PERSONS WITH KNEE OSTEOARTHRITIS', 'organization': {'class': 'OTHER', 'fullName': 'Foundation University Islamabad'}, 'officialTitle': 'SUPPLEMENTARY EFFECTS OF RESISTANCE TRAINING IN ADDITION TO JOINT MOBILIZATION IN PERSONS WITH KNEE OSTEOARTHRITIS', 'orgStudyIdInfo': {'id': 'FUI/CTR/2024/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator', 'interventionNames': ['Procedure: Joint Mobilization', 'Device: Transcutaneous Electric Nerve Stimulation (TENS)', 'Device: Heating Pad']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'interventionNames': ['Procedure: Joint Mobilization', 'Procedure: Resistance Exercise Training', 'Device: Transcutaneous Electric Nerve Stimulation (TENS)', 'Device: Heating Pad']}], 'interventions': [{'name': 'Joint Mobilization', 'type': 'PROCEDURE', 'description': 'Patellofemoral and tibiofemoral joint mobilization', 'armGroupLabels': ['Active Comparator', 'Experimental Group']}, {'name': 'Resistance Exercise Training', 'type': 'PROCEDURE', 'description': 'Lower limb resistance exercise training', 'armGroupLabels': ['Experimental Group']}, {'name': 'Transcutaneous Electric Nerve Stimulation (TENS)', 'type': 'DEVICE', 'description': 'Transcutaneous Electric Nerve Stimulation (TENS)', 'armGroupLabels': ['Active Comparator', 'Experimental Group']}, {'name': 'Heating Pad', 'type': 'DEVICE', 'description': 'Heating pad for heat therapy', 'armGroupLabels': ['Active Comparator', 'Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Foundation Univeristy Islamabad', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'Wania Maheen, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Foundation University Islamabad'}, {'name': 'Muhammad Osama, PhD*', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Foundation University Islamabad'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation University Islamabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}