- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06558617
Evaluating SARC-F, SARC-CalF, and Calf Circumference as Diagnostic Tools for Sarcopenia in Thai Older Adults: Results From a Nationwide Study
Study Overview
Status
Conditions
Detailed Description
The data utilized in this analysis were derived from the Thai Musculoskeletal Diseases Nationwide Study. This cross-sectional study targeted Thai adults aged 60 years and older, conducted between March 2021 and August 2022. Participants were sampled using a multi-level sampling technique to ensure representativeness from community-dwelling older adults across 12 provinces, encompassing Thailand's six primary geographical regions.
Participants were evaluated for possible sarcopenia or sarcopenia, according to AWGS 2019 criteria, by using SARC-F questionnaire, calf circumference measurement, SARC-CalF questionnaire, and appendicular skeletal muscle mass (ASM).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Bangkok
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Bangkoknoi, Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital, Mahidol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Thai adults aged 60 years and older
Exclusion Criteria:
- missing data on SARC-F, SARC-CalF, and calf circumference
- unable to walk independently
- bedridden individuals
- neuromuscular disorders or severe comorbidities that could impair their ability to perform performance-based tests
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Thai community-dwelling older adults
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The SARC-F scale consists of five components: strength, walking assistance, rising from a chair, stair climbing, and falls.
These elements were selected to reflect changes in health status related to the effects of sarcopenia.
Scores on the SARC-F scale range from 0 to 10, composed of five domains, assesses strength, walking assistance, raising from a chair, stair climbing and falls.
Each domain score ranges from 0-2.
A SARC-F score of ≥4 was considered abnormal.
The Thai-version SARC-F questionnaire has been validated in Thai older adults.
Calf circumference was measured using a nonelastic tape measure while the participant was standing with relaxed legs.
The tape was placed snugly and flat around the widest part of the calf, parallel to the floor.
According to the AWGS 2019 criteria, calf circumferences were considered abnormal if they were less than 34 cm for males and less than 33 cm for females.
This questionnaire integrates the SARC-F and calf circumference as a trigger for case finding.
If the calf circumference is below the cut-off value, 10 points are added to the SARC-F score for evaluation.
The SARC-CalF score ranges from 0 to 20, with a score of ≥11 considered abnormal for sarcopenia screening.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Appendicular skeletal muscle mass (ASM)
Time Frame: up to 4 weeks
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To assess appendicular skeletal muscle mass (ASM), we used the Tanita RD-545, a dual-frequency bioelectrical impedance analysis (BIA) device (Tanita Corporation, Tokyo, Japan).
Previous studies have demonstrated that this BIA method is reliable and comparable to dual-energy X-ray absorptiometry (DXA) for diagnosing sarcopenia in Thai elderly adults.
The appendicular skeletal muscle mass index (ASMI) was calculated by dividing the ASM by the square of the height.
According to the 2019 criteria of the AWGS, low muscle mass is defined as <7.0 kg/m² for men and <5.7 kg/m² for women.
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up to 4 weeks
|
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Handgrip strength
Time Frame: up to 4 weeks
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Participants were asked to squeeze a digital Smedley spring hand dynamometer (Takei 5401 Digital Dynamometer; Takei, Tokyo, Japan) with maximum effort while standing with fully extended arms at their sides.
The grip size was adjusted for each participant's hand size, and 2 or 3 trials were performed, with the highest output value recorded.
Handgrip strengths < 28 kg in males and < 18 kg in females were classified as low muscle strength, per the AWGS 2019 criteria.
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up to 4 weeks
|
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5-time sit-to-stand test (5TSTS)
Time Frame: up to 4 weeks
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Participants were directed to sit upright on armless chairs with their backs supported firmly by the backrest.
They were then instructed to stand up as quickly as possible for 5 repetitions with their arms crossed, trunk upright, and hips and knees fully extended.
The time taken by each participant to complete the test from the initial sitting to the fifth sitting was recorded.
The test is considered abnormal if it takes equal or more than 12 seconds to complete the task.
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up to 4 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Apichat Asavamongkolkul, MD, Siriraj Hospital
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
- COA-023/2024
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
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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