Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07460466
Status:
COMPLETED
Last Update Posted:
2026-03-11
First Post:
2026-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Eccentric Versus Concentric Quadriceps Exercises in Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This study is conducted as an open-label trial. Participants and treating therapists are aware of the assigned exercise intervention (eccentric or concentric quadriceps strengthening). No blinding of participants, care providers, or outcome assessors is performed.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are allocated into two parallel groups performing either eccentric or concentric quadriceps strengthening exercises for six weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quadriceps Muscle Strength', 'timeFrame': 'Baseline and Week 6', 'description': 'Quadriceps muscle strength measured in kilograms using the 10-repetition maximum (10-RM) method on the NK Table. The outcome is defined as the difference between baseline and post-intervention values at six weeks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee osteoarthritis', 'Quadriceps femoris', 'Eccentric exercise', 'Concentric exercise', 'Muscle strength', 'WOMAC'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effectiveness of eccentric and concentric quadriceps femoris strengthening exercises in patients with knee osteoarthritis. Knee osteoarthritis is a common musculoskeletal condition that causes pain, reduced joint movement, muscle weakness, and functional limitations.\n\nParticipants will be assigned to perform either eccentric or concentric unilateral open kinetic chain quadriceps exercises using isotonic loading based on a 10-repetition maximum (10-RM). The exercise program will be conducted three times per week for six weeks.\n\nThe primary objective is to evaluate differences in quadriceps muscle strength between the two exercise approaches. Secondary outcomes include changes in knee range of motion and functional capacity measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The results of this study are expected to provide evidence to guide exercise prescription in rehabilitation programs for patients with knee osteoarthritis.', 'detailedDescription': 'Knee osteoarthritis (KOA) is a leading cause of pain, disability, and reduced quality of life among older adults. Quadriceps femoris muscle weakness plays a central role in disease progression and functional impairment. Strengthening exercises are recommended as a core component of conservative management; however, the comparative effects of eccentric versus concentric muscle contractions remain incompletely defined.\n\nThis interventional comparative study is conducted at the Department of Physical Medicine and Rehabilitation, Dr. Cipto Mangunkusumo National General Hospital, Jakarta. A total of 24 patients diagnosed with knee osteoarthritis based on clinical and radiological criteria are recruited and allocated into two intervention groups.\n\nThe Eccentric Exercise Group performs unilateral open kinetic chain full-arc quadriceps exercises emphasizing eccentric contraction using the NK Table. The Concentric Exercise Group performs the same exercise emphasizing concentric contraction. Exercise sessions are conducted three times weekly for six weeks. Intensity is determined using a 10-repetition maximum (10-RM) method. During weeks 1-3, participants perform 3 sets of 6 repetitions; during weeks 4-6, the protocol progresses to 3 sets of 8 repetitions.\n\nOutcome measures include knee range of motion (measured with a goniometer), quadriceps muscle strength (assessed using the NK Table and recorded in kilograms), and functional capacity (evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index \\[WOMAC\\]). Measurements are obtained before and after the six-week intervention.\n\nThe study protocol has received ethical approval from the Ethics Committee of the Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo National General Hospital. All participants provide written informed consent prior to participation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'This study includes only female participants to reduce variability related to sex-specific differences in muscle strength and osteoarthritis characteristics.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female participants aged 40-59 years\n* Diagnosed with unilateral or bilateral knee osteoarthritis based on American College of Rheumatology (ACR) criteria and Kellgren-Lawrence grade II-III\n* Knee pain lasting more than 3 months with Numeric Rating Scale (NRS) score 1-3\n* Limited knee flexion range of motion\n\nExclusion Criteria:\n\n* History of unstable cardiovascular, respiratory, or metabolic disease\n* Knee joint instability due to cruciate or collateral ligament laxity or meniscal injury\n* Previous knee surgery\n* History of knee intra-articular injection within the last 3 months\n* Cognitive impairment (Montreal Cognitive Assessment Indonesian Version \\[MoCA-Ina\\] score \\< 26)\n* Clinical signs of tendinopathy characterized by pain during active knee extension (open or closed kinetic chain)\n* Balance disorders'}, 'identificationModule': {'nctId': 'NCT07460466', 'briefTitle': 'Eccentric Versus Concentric Quadriceps Exercises in Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Differences in Improvements of Knee Range of Motion, Muscle Strength, and Functional Capacity Between Eccentric and Concentric Quadriceps Femoris Exercises in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '895/UN2.F1/ETIK/PPM.00.02/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eccentric Exercise Group', 'description': 'Participants perform unilateral open kinetic chain full-arc quadriceps strengthening exercises emphasizing eccentric contraction using isotonic loading based on a 10-repetition maximum (10-RM), three times weekly for six weeks.', 'interventionNames': ['Other: Eccentric Quadriceps Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Concentric Exercise Group', 'description': 'Participants perform unilateral open kinetic chain full-arc quadriceps strengthening exercises emphasizing concentric contraction using isotonic loading based on a 10-repetition maximum (10-RM), three times weekly for six weeks.', 'interventionNames': ['Other: Concentric Quadriceps Exercise']}], 'interventions': [{'name': 'Eccentric Quadriceps Exercise', 'type': 'OTHER', 'description': 'Unilateral isotonic quadriceps strengthening emphasizing eccentric contraction using the NK Table, 3 sessions per week for 6 weeks, intensity based on 10-RM. Weeks 1-3: 3 sets of 6 repetitions; Weeks 4-6: 3 sets of 8 repetitions.', 'armGroupLabels': ['Eccentric Exercise Group']}, {'name': 'Concentric Quadriceps Exercise', 'type': 'OTHER', 'description': 'Unilateral isotonic quadriceps strengthening emphasizing concentric contraction using the NK Table, 3 sessions per week for 6 weeks, intensity based on 10-RM. Weeks 1-3: 3 sets of 6 repetitions; Weeks 4-6: 3 sets of 8 repetitions.', 'armGroupLabels': ['Concentric Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Department of Physical Medicine and Rehabilitation', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'researcher', 'investigatorFullName': 'Fally Usman Arif', 'investigatorAffiliation': 'Indonesia University'}}}}