Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-26 @ 2:53 AM
Study NCT ID:
NCT05758792
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2022-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle Quality, Fall Concern and Lower Extremity Functionality in Older Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2022-11-25', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle Quality Index', 'timeFrame': '6 months', 'description': 'Muscle Quality Index scored is calculated through anthropometric measurements of older adults. The muscle quality depends on the formula as follows: MQI (Watts) = ((Leg length×0.4)×Body mass×gravity ×10)/ Five Times Sit To Stand.'}, {'measure': 'Lower Extremity Functional Scale', 'timeFrame': '6 months', 'description': 'LEFS presents 20 questions about daily living activities. The questionnaire was developed to assess lower extremity functionality and can be used in older adults.The minimum and maximum total score ranges from 0 to 80. High scores show high functional status.'}, {'measure': 'International Fall Efficiency Scale', 'timeFrame': '6 months', 'description': 'The scale consist of items about fall concern during daily living activities. The minimum and maximum total score ranges from 16 to 64. High scores represents high fall concern.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Old Age; Debility', 'Age-Related Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '10201543', 'type': 'RESULT', 'citation': 'Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.'}, {'pmid': '24508922', 'type': 'RESULT', 'citation': 'Fragala MS, Fukuda DH, Stout JR, Townsend JR, Emerson NS, Boone CH, Beyer KS, Oliveira LP, Hoffman JR. Muscle quality index improves with resistance exercise training in older adults. Exp Gerontol. 2014 May;53:1-6. doi: 10.1016/j.exger.2014.01.027. Epub 2014 Feb 6.'}, {'pmid': '29329971', 'type': 'RESULT', 'citation': 'Gadelha AB, Neri SGR, Nobrega OT, Pereira JC, Bottaro M, Fonseca A, Lima RM. Muscle quality is associated with dynamic balance, fear of falling, and falls in older women. Exp Gerontol. 2018 Apr;104:1-6. doi: 10.1016/j.exger.2018.01.003. Epub 2018 Jan 9. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study was to investigate the effects of muscle quality on fear of fall, and lower extremity functionality in older women. The differences between muscle quality, fear of falling and lower extremity functionality in the elderly male and female participating in the study were investigated. Older women had worse muscle quality, higher fall concern and less lower extremity functionality than older men.', 'detailedDescription': 'The effects of muscle quality and lower extremity functionality, and fear of falling in older women are not well-known compared to older men in the same age group. The aim of the study was to investigate the effects of muscle quality on lower extremity functionality and fear of falling in older women. 168 age-matched older adults participated in the study. The muscle quality Index, fear of fall, and lower extremity functionality were evaluated. The results of older women and men were compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Age-matched older men and women were included in the study.', 'genderDescription': 'This study was planned to investigate the effects of muscle quality on older women comparing to older men.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 65 years old or older\n* Having no neurological, orthopedic, communicational,\n* Mental disability that affects the evaluations.\n\nExclusion Criteria:\n\n* Incomplete data and older adults not agreeing to participate in the study.'}, 'identificationModule': {'nctId': 'NCT05758792', 'briefTitle': 'Muscle Quality, Fall Concern and Lower Extremity Functionality in Older Women', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Does Poor Muscle Quality in Older Women Affect Fall Concern and Lower Extremity Functionality?', 'orgStudyIdInfo': {'id': '60116787-020/71654'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Muscle Quality Index', 'type': 'OTHER', 'otherNames': ['Lower Extremity Functional Scale', 'International Fall Efficiency Scale'], 'description': 'Evaluations are applied to older adults to compare the results of muscle quality.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20160', 'city': 'Denizli', 'state': 'Pamukkale', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale University', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'overallOfficials': [{'name': 'Güzin Kara Çakıcı, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pamukkale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT., PhD.', 'investigatorFullName': 'Güzin Kara', 'investigatorAffiliation': 'Pamukkale University'}}}}