- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06931964
Frailty and Assocciated Factors in Sarcopenia
The Level of Frailty in Individuals Diagnosed With Primary Sarcopenia; Balance, Fall Risk and Impact on Kinesiophobia
Primary sarcopenia is a condition that occurs with the aging process and is characterized by symptoms such as decreased muscle mass, impaired muscle function and decreased physical strength. The decrease in muscle mass can lead to a decrease in physical strength, balance and mobility, making older people more prone to frailty and falls, which can lead to a fear of falling. Although there are few studies on sarcopenia in the literature, the level of frailty in sarcopenia is related to balance, falls risk and kinesiophobia in sarcopenia.
Our aim in the study was to measure frailty in elderly individuals diagnosed with sarcopenia and to determine the level of frailty.
to evaluate the effect of sarcopenia on fall risk, balance and kinesiophobia and to evaluate the effect of sarcopenia on fall risk, balance and kinesiophobia according to the results of the evaluation and new rehabilitation programs on frailty, falls, kinesiophobia and balance resulting from sarcopenia and to be the basic data for the programs to be created.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Karabük, Turkey, 78000
- Karabuk University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- Volunteering to participate in the study
- 65 years of age or older
- Being diagnosed with primary sarcopenia by a specialist
- To have the cooperation to perform the measurements
Exclusion criteria:
- Having a disease that will affect balance (vertigo etc.)
- Not volunteering to participate in the study
- History of trauma within the last six months (fracture, soft tissue injury, etc.)
- Having undergone lower extremity surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Sarcopenia
According to EWGSOP2 criteria; individuals diagnosed with sarcopenia were included in the study by evaluating low muscle strength, low muscle quantity or quality, and low physical performance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Frailty
Time Frame: Baseline
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Frailty will be assessed with the Edmonton Frailty Scale.
It is scored between 0-17.
Frailty increases as the score increases.
0-4 points: Not frail, 5-6 points: Mildly frail, 7-8 points: Moderately frail, 9-17 points: Severely frail.
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Baseline
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Risk of falling
Time Frame: Baseline
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Fall risk will be assessed with the Denn Fall Risk Assessment Scale.
The total score is generally: 0-3: Low risk, 4-6: Medium risk, 7 and above: High risk.
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Baseline
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Kinesiophobia
Time Frame: Baseline
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The Tampa Kinesiophobia Scale will be used to assess kinesiophobia.
Total score: 17-68.
Higher scores indicate greater kinesiophobia (fear of movement).
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Baseline
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Balance
Time Frame: Baseline
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Balance will be assessed with a posturography device.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Metehan Yana, Karabuk University
- Principal Investigator: Ecem Çoroğlu, BD, Karabuk University
Publications and helpful links
General Publications
- Ye L, Liang R, Liu X, Li J, Yue J, Zhang X. Frailty and sarcopenia: A bibliometric analysis of their association and potential targets for intervention. Ageing Res Rev. 2023 Dec;92:102111. doi: 10.1016/j.arr.2023.102111. Epub 2023 Oct 29.
- Alvarez-Bustos A, Carnicero-Carreno JA, Davies B, Garcia-Garcia FJ, Rodriguez-Artalejo F, Rodriguez-Manas L, Alonso-Bouzon C. Role of sarcopenia in the frailty transitions in older adults: a population-based cohort study. J Cachexia Sarcopenia Muscle. 2022 Oct;13(5):2352-2360. doi: 10.1002/jcsm.13055. Epub 2022 Jul 28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Karabuk 001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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