- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04757454
Performance Indicators of the SARC-F Questionnaire in Acute Care (SARC-F-CHUB)
February 12, 2021 updated by: Murielle Surquin, Brugmann University Hospital
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
105
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brussels, Belgium, 1020
- Brugmann University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients aged 65 and over hospitalized in an acute care geriatric unit due to acute medical conditions, where the SARC-F questionnaire and the EWGSOP2 was available
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity of the SARC-F questionnaire as screening method compared to the gold standard, which is the revised European consensus on definition and diagnosis
Time Frame: September 2019-November 2020
|
Sensitivity, measured as a percentage (%)
|
September 2019-November 2020
|
|
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)
Time Frame: September 2019-November 2020
|
Specificity, measured as a percentage (%)
|
September 2019-November 2020
|
|
Overall concordance agreement between the SARC-F questionnaire as a screening method and the gold standard method, which is the EWGSOP2
Time Frame: September 2019-November 2020
|
Cohen-kappa coefficient, measured as a percentage (%)
|
September 2019-November 2020
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health adverse outcomes based on the screening and diagnosis of sarcopenia as recommended by the EWGSOP2
Time Frame: 1-year follow-up
|
Mortality risk
|
1-year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Murielle Surquin, Head of the Geriatrics Department
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere 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.
- Sanchez-Rodriguez D, Marco E, Davalos-Yerovi V, Lopez-Escobar J, Messaggi-Sartor M, Barrera C, Ronquillo-Moreno N, Vazquez-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.
- Piotrowicz K, Głuszewska A, Czesak J, Fedyk-Łukasik M, Klimek E, Sánchez-Rodríguez D, Skalska A, Gryglewska B, Grodzicki T, Gąsowski 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 Jul;33(7):1821-1829. doi: 10.1007/s40520-020-01782-y. Epub 2021 Jan 28.
- 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. Review.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Actual)
November 11, 2020
Study Completion (Actual)
November 11, 2020
Study Registration Dates
First Submitted
February 8, 2021
First Submitted That Met QC Criteria
February 12, 2021
First Posted (Actual)
February 17, 2021
Study Record Updates
Last Update Posted (Actual)
February 17, 2021
Last Update Submitted That Met QC Criteria
February 12, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUB SARC-F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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