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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05758792
Other study ID # 60116787-020/71654
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 20, 2021
Est. completion date August 26, 2022

Study information

Verified date March 2023
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date August 26, 2022
Est. primary completion date August 30, 2021
Accepts healthy volunteers
Gender All
Age group 65 Years to 85 Years
Eligibility Inclusion Criteria: - Being 65 years old or older - Having no neurological, orthopedic, communicational, - Mental disability that affects the evaluations. Exclusion Criteria: - Incomplete data and older adults not agreeing to participate in the study.

Study Design


Intervention

Other:
Muscle Quality Index
Evaluations are applied to older adults to compare the results of muscle quality.

Locations

Country Name City State
Turkey Pamukkale University Denizli Pamukkale

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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 2 — View 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. N — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Quality Index 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. 6 months
Primary Lower Extremity Functional Scale 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. 6 months
Primary International Fall Efficiency Scale 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. 6 months
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