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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04757454
Other study ID # CHUB SARC-F
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date November 11, 2020

Study information

Verified date February 2021
Source Brugmann University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study applies the Sluggishness, Assistance in walking, Rising from a chair, Climb stairs, Falls (SARC-F) questionnaire in older patients hospitalized in an acute care geriatric unit and aims to determine its performance indicators to screen for sarcopenia according to the revised European Consensus on definition and diagnosis (EWGSOP2) within this population


Description:

Sarcopenia is an age-related disease associated with health adverse outcomes, i.e. higher risk of mobility limitation, falls, fractures, mortality, and lower quality of life. The European Working Group on Sarcopenia has recently revisited one of the widely used most acknowledged definitions and launched the revised European consensus on definition and diagnosis (EWGSOP2) (4). Applying the EWGSOP2 is a three-tier process: first, screening by the Sluggishness, Assistance in walking, Rising from a chair, Climb stairs, Falls (SARC-F) questionnaire; second, diagnosis by low muscle strength, and low muscle mass; third, severity grading by low muscle function. The EWGSOP2 recommends the assessment of sarcopenia in every population, both in community-dwelling and acute care older patients. However, the evidence about the performance indicators of the SARC-F questionnaire to screen for sarcopenia in acute patients admitted to an acute care unit is really limited.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date November 11, 2020
Est. primary completion date November 11, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Patients aged 65 and over - Hospitalized in an acute care geriatric unit due to acute health issues or acute medical conditions - With SARC-F, hand-grip strength and dual-energy X-ray absorptiometry administered during hospital admission Exclusion Criteria: - SARC-F unavailable - Unwilling to collaborate in the sarcopenia assessment - Unwilling to sign the informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
5-item SARC-F questionnaire
Administration of the 5-item SARC-F questionnaire in patients admitted to an acute care unit

Locations

Country Name City State
Belgium Brugmann university hospital Brussels

Sponsors (1)

Lead Sponsor Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyère O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169. Erratum in: Age Ageing. 2019 Jul 1;48(4):601. — View Citation

Piotrowicz K, Gluszewska A, Czesak J, Fedyk-Lukasik M, Klimek E, Sánchez-Rodríguez D, Skalska A, Gryglewska B, Grodzicki T, Gasowski J. SARC-F as a case-finding tool for sarcopenia according to the EWGSOP2. National validation and comparison with other diagnostic standards. Aging Clin Exp Res. 2021 Jan 28. doi: 10.1007/s40520-020-01782-y. [Epub ahead of print] — View Citation

Sanchez-Rodriguez D, Marco E, Cruz-Jentoft AJ. Defining sarcopenia: some caveats and challenges. Curr Opin Clin Nutr Metab Care. 2020 Mar;23(2):127-132. doi: 10.1097/MCO.0000000000000621. — View Citation

Sánchez-Rodríguez D, Marco E, Dávalos-Yerovi V, López-Escobar J, Messaggi-Sartor M, Barrera C, Ronquillo-Moreno N, Vázquez-Ibar O, Calle A, Inzitari M, Piotrowicz K, Duran X, Escalada F, Muniesa JM, Duarte E. Translation and Validation of the Spanish Version of the SARC-F Questionnaire to Assess Sarcopenia in Older People. J Nutr Health Aging. 2019;23(6):518-524. doi: 10.1007/s12603-019-1204-z. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity of the SARC-F questionnaire as screening method compared to the gold standard, which is the revised European consensus on definition and diagnosis Sensitivity, measured as a percentage (%) September 2019-November 2020
Primary Specificity of the SARC-F questionnaire as a screening method, compared to the gold standard which is the revised European Consensus on definition and diagnosis of sarcopenia (EWGSOP2) Specificity, measured as a percentage (%) September 2019-November 2020
Primary Overall concordance agreement between the SARC-F questionnaire as a screening method and the gold standard method, which is the EWGSOP2 Cohen-kappa coefficient, measured as a percentage (%) September 2019-November 2020
Secondary Health adverse outcomes based on the screening and diagnosis of sarcopenia as recommended by the EWGSOP2 Mortality risk 1-year follow-up
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