- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05758792
Muscle Quality, Fall Concern and Lower Extremity Functionality in Older Women
March 6, 2023 updated by: Güzin Kara, Pamukkale University
Does Poor Muscle Quality in Older Women Affect Fall Concern and Lower Extremity Functionality?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
168
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pamukkale
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Denizli, Pamukkale, Turkey, 20160
- Pamukkale University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Age-matched older men and women were included in the study.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Quality Index
Time Frame: 6 months
|
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
|
Lower Extremity Functional Scale
Time Frame: 6 months
|
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
|
International Fall Efficiency Scale
Time Frame: 6 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Güzin Kara Çakıcı, PhD, Pamukkale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2021
Primary Completion (Actual)
August 30, 2021
Study Completion (Actual)
August 26, 2022
Study Registration Dates
First Submitted
November 25, 2022
First Submitted That Met QC Criteria
March 6, 2023
First Posted (Estimate)
March 7, 2023
Study Record Updates
Last Update Posted (Estimate)
March 7, 2023
Last Update Submitted That Met QC Criteria
March 6, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60116787-020/71654
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to make individual participant data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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