NCT06558617

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,543

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

1.5 years

First QC Date

August 10, 2024

Last Update Submit

August 17, 2024

Conditions

Keywords

sarcopeniacalf circumferenceSARC-F questionnairediagnostic accuracyelderly

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    up to 4 weeks

Study Arms (1)

Thai community-dwelling older adults

Diagnostic Test: SARC-F QuestionnaireDiagnostic Test: Calf Circumference MeasurementDiagnostic Test: SARC-CalF Questionnaire

Interventions

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.

Thai community-dwelling 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.

Thai community-dwelling older adults

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.

Thai community-dwelling older adults

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community-dwelling older Thai adults living at that area for at least 1 year

You may qualify if:

  • Thai adults aged 60 years and older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SarcopeniaDisease

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Study Officials

  • Apichat Asavamongkolkul, MD

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 10, 2024

First Posted

August 16, 2024

Study Start

March 1, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations