Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-30 @ 5:56 AM
Study NCT ID:
NCT07084857
Status:
COMPLETED
Last Update Posted:
2025-07-25
First Post:
2025-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Association Between Isokinetic Lower Extremity Muscle Strength and Bone Mineral Density in Elderly Women With and Without Osteoporosis: A Case-Control Study"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'isokinetic strength of hip muscles', 'timeFrame': 'one month', 'description': 'isokinetic hip muscle stregth will be measured using Biodex system 3 Isokinetic Dynamometer'}, {'measure': 'Bone mineral density', 'timeFrame': 'one month', 'description': 'bone mineral density measured by dual energy x ray absorptiometry scan'}], 'secondaryOutcomes': [{'measure': 'isokinetic strength of knee muscles', 'timeFrame': 'one month', 'description': 'isokinetic hip muscle stregth will be measured using Biodex system 3 Isokinetic Dynamometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoporosis; Bone Mineral Density; Isokinetic Strength; Hip Muscles; Knee Muscles; Elderly Women'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'bone density and muscle strength appear to be more related to each other. Examining the association between muscle strength and bone health is very important in recognizing risk factors for lower extremity muscle weakness.', 'detailedDescription': 'Dual Energy X-ray Absorptiometry (DEXA) scan will be used to assess hip bone mineral density (BMD) at femoral head region. Isokinetic PT of hip flexors, extensors, abductors and adductors and knee flexors and extensors will be measured using Biodex System 3 Isokinetic Dynamometer. The measured outcomes will be evaluated at an angular velocity of 60°/sec in a concentric mode of muscle contraction for five successive repetitions. Isokinetic testing will be done at the Isokinetic Laboratory, Faculty of Physical therapy, Cairo University.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Based on a sample size calculation via G Power software, a total of 70 participants will be required to participate in the study taking in consideration 20% drop out. A total 66 elderly women with ages range from 50 to 70 years will be involved in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The group of OP (n=33) has femoral BMD T-scores below -2.5 diagnosed by DEXA scan according to the WHO \\[8\\] classification of BMD in 2003,\n2. The control group has normal BMD T-scores more than -1.\n\nExclusion Criteria:\n\n1. There was any neurological, musculoskeletal, rheumatologic, respiratory or cardiovascular problem.\n2. They were receiving medications that result in bone loss such as corticosteroids,\n3. They had vertigo, dizziness, or any vestibular problem,\n4. They had hyperthyroidism or hyperparathyroidism. 6- They actively participate in sports activities,\n5. They underwent previous surgery (e.g; joint replacement) or history of fractures of the lower extremity.'}, 'identificationModule': {'nctId': 'NCT07084857', 'briefTitle': '"Association Between Isokinetic Lower Extremity Muscle Strength and Bone Mineral Density in Elderly Women With and Without Osteoporosis: A Case-Control Study"', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': '"Association Between Isokinetic Lower Extremity Muscle Strength and Bone Mineral Density in Elderly Women With and Without Osteoporosis: A Case-Control Study"', 'orgStudyIdInfo': {'id': 'Faculty of Physical Therapy CU'}, 'secondaryIdInfos': [{'id': 'faculty of physical therapy', 'type': 'REGISTRY', 'domain': 'faculty of physical therapy'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'correlational analysis between BMD and isokinetic lower extremity strength', 'type': 'OTHER', 'description': 'correlational analysis between BMD and isokinetic lower extremity strength'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12511', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Azza Mohammed', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr', 'investigatorFullName': 'Azza Mohammed', 'investigatorAffiliation': 'Cairo University'}}}}