SarcopeniaNCT06558617
Evaluating SARC-F, SARC-CalF, and Calf Circumference as Diagnostic Tools for Sarcopenia in Thai Older Adults: Results From a Nationwide Study
An observational study of Sarcopenia and Diagnosis, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
As the elderly population grows, musculoskeletal disorders, including sarcopenia, have become a critical area of study due to their association with falls and fractures. Sarcopenia, characterized by decreased muscle mass, is prevalent among older adults and poses a significant risk for falls. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Diagnosis
- What is being tested?
- SARC-F Questionnaire, Calf Circumference Measurement and SARC-CalF Questionnaire
- How many people
- 2,543 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2021to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community-dwelling older Thai adults living at that area for at least 1 year
Who may be able to join
- Thai adults aged 60 years and older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
About this study
As the elderly population grows, musculoskeletal disorders, including sarcopenia, have become a critical area of study due to their association with falls and fractures. Sarcopenia, characterized by decreased muscle mass, is prevalent among older adults and poses a significant risk for falls. This study aimed to assess the effectiveness of the SARC-F and SARC-CalF questionnaires, along with calf circumference measurements, in screening for sarcopenia among Thai community-dwelling older adults, following the Asian Working Group on Sarcopenia (AWGS) 2019 criteria.
Read the 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).
- Conditions
- Sarcopenia, Diagnosis
- Being tested
- SARC-F Questionnaire, Calf Circumference Measurement, SARC-CalF Questionnaire
- Keywords
- sarcopenia, calf circumference, SARC-F questionnaire, diagnostic accuracy, elderly
- Medical subject headings
- Sarcopenia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARC-F QuestionnaireDiagnostic test
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 MeasurementDiagnostic test
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.
SARC-CalF QuestionnaireDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Thai community-dwelling older adults | Not described Receives: Diagnostic Test: SARC-F Questionnaire; Diagnostic Test: Calf Circumference Measurement; Diagnostic Test: SARC-CalF Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendicular skeletal muscle mass (ASM)
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.
Measured: up to 4 weeks
Handgrip strength
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.
Measured: up to 4 weeks
5-time sit-to-stand test (5TSTS)
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.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Mar 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,543 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Thailand
- Responsible party
- Principal investigator, Panai Laohaprasitiporn, MD, Siriraj Hospital
- Investigators
- Apichat Asavamongkolkul, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558617
- Sponsor's protocol ID
- COA-023/2024
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vanitcharoenkul E, Unnanuntana A, Chotiyarnwong P, Adulkasem N, Asavamongkolkul A, Laohaprasitiporn P. Evaluating SARC-F, SARC-CalF, and calf circumference as diagnostic tools for sarcopenia in Thai older adults: results from a nationwide study. BMC Geriatr. 2024 Dec 28;24(1):1043. doi: 10.1186/s12877-024-05637-3.
PubMed 39732657
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating SARC-F, SARC-CalF, and Calf Circumference as Diagnostic Tools for Sarcopenia in Thai Older Adults: Results From a Nationwide Study
- ClinicalTrials.gov ID
- NCT06558617
- Acronym / sponsor ID
- COA-023/2024
- Conditions
- Sarcopenia, Diagnosis
- Keywords
- sarcopenia, calf circumference, SARC-F questionnaire, diagnostic accuracy, elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,543 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Collaborators
- National Research Council of Thailand
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As the elderly population grows, musculoskeletal disorders, including sarcopenia, have become a critical area of study due to their association with falls and fractures. Sarcopenia, characterized by decreased muscle mass, is prevalent among older adults and poses a significant risk for falls. This study aimed to assess the effectiveness of the SARC-F and SARC-CalF questionnaires, along with calf circumference measurements, in screening for sarcopenia among Thai community-dwelling older adults, following the Asian Working Group on Sarcopenia (AWGS) 2019 criteria.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thai community-dwelling older adults | – | Diagnostic Test: SARC-F Questionnaire, Diagnostic Test: Calf Circumference Measurement, Diagnostic Test: SARC-CalF Questionnaire |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling older Thai adults living at that area for at least 1 year
Key inclusion criteria (1 listed)
- Thai adults aged 60 years and older
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARC-F QuestionnaireThe 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. | Diagnostic test | Thai community-dwelling older adults |
| Calf Circumference MeasurementCalf 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. | Diagnostic test | Thai community-dwelling older adults |
| SARC-CalF QuestionnaireThis 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. | Diagnostic test | Thai community-dwelling older adults |
Primary outcome
Appendicular skeletal muscle mass (ASM)
Time frame: up to 4 weeks
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.
Handgrip strength
Time frame: up to 4 weeks
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.
5-time sit-to-stand test (5TSTS)
Time frame: up to 4 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Derived from this study: PubMed 39732657Vanitcharoenkul E, Unnanuntana A, Chotiyarnwong P, Adulkasem N, Asavamongkolkul A, Laohaprasitiporn P. Evaluating SARC-F, SARC-CalF, and calf circumference as diagnostic tools for sarcopenia in Thai older adults: results from a nationwide study. BMC Geriatr. 2024 Dec 28;24(1):1043. doi: 10.1186/s12877-024-05637-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Apichat Asavamongkolkul, MD principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Diagnosis, run by Siriraj Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appendicular skeletal muscle mass (ASM) (time frame: up to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06558617, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.