Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT06664905
Status:
COMPLETED
Last Update Posted:
2024-10-30
First Post:
2023-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Resistance Exercise in Severe Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2023-04-14', 'studyFirstSubmitQcDate': '2024-10-28', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in self-reported pain intensity', 'timeFrame': 'Pre-exercise (pre), immediate post exercise (post), and 10 min after exercise (post 10min)', 'description': 'Measure of knee pain intensity with the Visual Analogue Scale (0-100mm), with higher scores reflecting higher perceived pain intensity'}, {'measure': 'Change in pressure pain thresholds', 'timeFrame': 'Pre-exercise (pre), immediate post exercise (post), and 10 min after exercise (post 10min)', 'description': 'Measured with a mechanical algometer (Wagner Instruments, Greenwich, CT, USA) in three sites (vastus medialis of the affected limb, vastus medialis of the unaffected limb, and distal to the non-dominant arm lateral epicondyle)'}], 'secondaryOutcomes': [{'measure': 'WOMAC questionaire', 'timeFrame': 'pre-exercise', 'description': 'A self-administered questionnaire for patients with hip or knee osteoarthritis. contain 24 items grouped into three dimensions: pain (5 items), stiffness (2 items) and physical function (17 items). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.'}, {'measure': 'Tampa Scale of Kinesiophobia (TSK 11)', 'timeFrame': 'pre-exercise', 'description': 'Measure fear of movement and its score ranges from 11-44 with higher scores indicate an increasing degree of kinesiophobia'}, {'measure': 'Chronic Pain Self-Efficacy Scale', 'timeFrame': 'pre-exercise', 'description': 'Measures three domains of pain self-efficacy: pain management, physical functioning, and coping with symptoms management, physical functioning, and coping with symptomsmanagement, physical functioning, and coping with symptoms. A higher score suggests higher self-efficacy'}, {'measure': 'Pain Catastrophizing Scale', 'timeFrame': 'pre-exercise', 'description': 'People are asked to indicate the degree to which they have certain thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness, with higher scores reflecting worse condition.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resistance Training', 'Knee Osteoarthritis', 'Pain'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study aim to evaluate pain after different resistance training protocols (placebo, 4 sets of 10RM, 8 sets of 10 RM and 12 sets of 10RM) in patients with severe knee osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women at least 55 years old\n* diagnosed with severe knee OA\n* scheduled for unilateral Total Knee Arthroplasty (TKA) surgery\n\nExclusion Criteria:\n\n* pain in the contralateral (non-studied) limb (maximum ≥80 of 100 mm on a visual analog scale (VAS) during daily activities)\n* another hip or knee joint replacement in the previous year\n* any medical condition in which exercise was contraindicated\n* participated in exercise programs (\\>2 days/week, training at intensities of 10-15RM) in the 6 months prior to the study\n* history of stroke, brain surgery, major depression, or any self-perceived cognitive alterations that could affect the performance of study tasks'}, 'identificationModule': {'nctId': 'NCT06664905', 'acronym': 'RTOA', 'briefTitle': 'Resistance Exercise in Severe Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Valencia'}, 'officialTitle': 'Impact of Different Resistance Training Protocols on Pain in Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'OA-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': 'control, with no exercise', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '4 sets', 'description': '4 sets of 10RM of knee extensions', 'interventionNames': ['Other: Resistance Exercise']}, {'type': 'EXPERIMENTAL', 'label': '8 sets', 'description': '8 sets of 10RM of knee extensions', 'interventionNames': ['Other: Resistance Exercise']}, {'type': 'EXPERIMENTAL', 'label': '12 sets', 'description': '12 sets of 10RM of knee extensions', 'interventionNames': ['Other: Resistance Exercise']}], 'interventions': [{'name': 'Resistance Exercise', 'type': 'OTHER', 'description': '10 Repetition Maximum (RM)', 'armGroupLabels': ['12 sets', '4 sets', '8 sets']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Control'], 'description': 'No exercise', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Valencia', 'country': 'Spain', 'facility': 'Clinic Universitary Hospital of Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Valencia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Physiotherapy Department', 'investigatorFullName': 'José Casaña Granell', 'investigatorAffiliation': 'University of Valencia'}}}}