Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:21 AM
Study NCT ID:
NCT07478861
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-18
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole-body Vibration Training on the Elderly With Combined Bilateral 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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will aim to evaluate the effects of whole-body vibration training (WBVT) on body composition, muscle strength (hand grip strength), and physical performance \\[gait speed (GS), 5-time chair stand test (5CST), and short physical performance battery (SPPB), pain intensity, triglycerides in older people with knee OA and sarcopenic obesity in a group of Men compared to group of females.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical performance', 'timeFrame': '8 weeks', 'description': 'These are standardized tests used to assess lower limb strength, mobility, and overall functional ability in elderly patients it includes: 1. Gait speed (it is the rate a person can tolerate walking measured in meter per seconds (ask the person to walk at their usual comfortable pace for 10 meters; and record how many seconds it takes to complete this distance and evaluate the recorded time before and after the treatment); 2. 5-time chair stand test; t evaluates how quickly a participant can perform 5 successive sit-to-stand without using their arms (it evaluate the time taken to complete 5 repetitions, a. ≤ 12 seconds is considered normal physical performance, b. \\> 15 seconds may indicate lower extremity weakness, mobility limitations, or increased fall risk, c. Unable to complete indicates significant functional impairment). All measurements will be carried out before the treatment and after the end of the treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee osteoarthritis', 'elderly patients', 'sarcopenic obesity', 'whole body vibration training'], 'conditions': ['Knee OA', 'Sarcopenic Obesity', 'Whole Body Vibration']}, 'descriptionModule': {'briefSummary': 'This study will aim to evaluate the effects of whole-body vibration training (WBVT) on body composition, muscle strength (hand grip strength), and physical performance \\[gait speed (GS), 5-time chair stand test (5CST), and short physical performance battery (SPPB), pain intensity, triglycerides in older people with knee OA and sarcopenic obesity in a group of Men compared to group of females.', 'detailedDescription': 'Both groups received the intervention 3 times a week for 12 weeks. WBVT group. Each intervention lasted 30 min, which included 5 min of warm-up, 20 min of vibration training, and 5 min of relaxation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with KOA were graded based on the Kellgren-Lawrence grading criteria (K-L grading)\n* only grades 3 and 4 will be included in this study\n* Sarcopenia obesity based on with SMI with SMI \\< 7 kg/m2\n* PBF ≥ 30% into the SO group\n* BMI ≥ 28%, or waist circumference ≥ 85 cm in men and ≥ 80 cm in women\n* able to communicate\n\nExclusion Criteria:\n\n* Inability to walk\n* Knee joint underwent drug treatment or intra-articular injection\n* Uncontrollable angina pectoris induced by exercise\n* Uncontrolled hypertension, acute or chronic renal failure, or dyspnea in the resting state\n* Neurological or respiratory conditions or injuries (ie, dementia, Alzheimer's disease, multiple sclerosis, chronic obstructive pulmonary disease), rheumatoid arthritis and clinical depression."}, 'identificationModule': {'nctId': 'NCT07478861', 'acronym': 'RCT', 'briefTitle': 'Whole-body Vibration Training on the Elderly With Combined Bilateral Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Impact of Whole-body Vibration Training (WBVT) on the Elderly With Combined Bilateral Knee Osteoarthritis (KOA) and Sarcopenic Obesity', 'orgStudyIdInfo': {'id': 'Faculty of Physical Therapy'}, 'secondaryIdInfos': [{'id': 'Mariam Abdel Rahman', 'type': 'REGISTRY', 'domain': 'Mariam Abdel Mohamed Abd Allah'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elderly male patients with knee osteoarthritis', 'description': 'Elderly male patients with knee osteoarthritis associated with sarcopenic obesity', 'interventionNames': ['Other: Whole-body vibration training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Elderly female patients with knee osteoarthritis', 'description': 'Elderly female patients with knee osteoarthritis associated with sacropenic obesity', 'interventionNames': ['Other: Whole-body vibration training']}], 'interventions': [{'name': 'Whole-body vibration training', 'type': 'OTHER', 'description': 'Whole-body vibration therapy stimulates muscle contraction. It can increase muscle function to a level like that of classical resistance training, but with the advantage of being more convenient and safer', 'armGroupLabels': ['Elderly female patients with knee osteoarthritis', 'Elderly male patients with knee osteoarthritis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banī Suwayf', 'country': 'Egypt', 'facility': 'Beni Suef University Hospital', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mariam Abdel Rahman Mohamed Abd Allah Lecturer of Orthopaedic Physical Therapy', 'investigatorFullName': 'Mariam Abdel Rahman', 'investigatorAffiliation': 'Beni-Suef University'}}}}