SarcopeniaSARC-F-CHUBNCT04757454
Performance Indicators of the SARC-F Questionnaire in Acute Care
An observational study of Sarcopenia and Sensitivity, run by Brugmann University Hospital at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia, Sensitivity, Old Age; Debility
- What is being tested?
- 5-item SARC-F questionnaire
- How many people
- 105 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2019to 11 Nov 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- 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
Who cannot join
- SARC-F unavailable
- Unwilling to collaborate in the sarcopenia assessment
- Unwilling to sign the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Sarcopenia, Sensitivity, Old Age; Debility
- Being tested
- 5-item SARC-F questionnaire
- Medical subject headings
- Sarcopenia, Hypersensitivity, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-item SARC-F questionnaireDiagnostic test
Administration of the 5-item SARC-F questionnaire in patients admitted to an acute care unit
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: 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)
Specificity, measured as a percentage (%)
Measured: 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
Cohen-kappa coefficient, measured as a percentage (%)
Measured: September 2019-November 2020
Secondary outcomes (1)
Health adverse outcomes based on the screening and diagnosis of sarcopenia as recommended by the EWGSOP2
Mortality risk
Measured: 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Sep 2019
- Primary completion11 Nov 2020
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murielle Surquin, Brugmann University Hospital
- Investigators
- Murielle Surquin, Principal investigator, Head of the Geriatrics Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757454
- Sponsor's protocol ID
- CHUB SARC-F
- Acronym
- SARC-F-CHUB
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31233072Piotrowicz K, Gluszewska A, Czesak J, Fedyk-Lukasik M, Klimek E, Sanchez-Rodriguez 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 Jul;33(7):1821-1829. doi: 10.1007/s40520-020-01782-y. Epub 2021 Jan 28.
PubMed 33506313Sanchez-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.
PubMed 31789867Cruz-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.
PubMed 30312372
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Indicators of the SARC-F Questionnaire in Acute Care
- ClinicalTrials.gov ID
- NCT04757454
- Acronym / sponsor ID
- SARC-F-CHUB / CHUB SARC-F
- Conditions
- Sarcopenia, Sensitivity, Old Age; Debility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 17 Feb 2021 (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.
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
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- SARC-F unavailable
- Unwilling to collaborate in the sarcopenia assessment
- Unwilling to sign the informed consent
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 |
|---|---|---|
| 5-item SARC-F questionnaireAdministration of the 5-item SARC-F questionnaire in patients admitted to an acute care unit | Diagnostic test | – |
Primary outcome
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 (%)
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 (%)
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 (%)
1 secondary outcome
Health adverse outcomes based on the screening and diagnosis of sarcopenia as recommended by the EWGSOP2
Time frame: 1-year follow-up
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 17 Feb 2021.
- Background: PubMed 31233072Sanchez-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.
- Background: PubMed 33506313Piotrowicz K, Gluszewska A, Czesak J, Fedyk-Lukasik M, Klimek E, Sanchez-Rodriguez 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 Jul;33(7):1821-1829. doi: 10.1007/s40520-020-01782-y. Epub 2021 Jan 28.
- Background: PubMed 31789867Sanchez-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.
- Background: PubMed 30312372Cruz-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.
- 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.
Murielle Surquin principal investigator
Head of the Geriatrics Department
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 Sensitivity, run by Brugmann University Hospital at 1 site in Belgium.
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 3 inclusion and 3 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 17 Feb 2021. 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 Belgium. 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?
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). 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 NCT04757454, which also lists 4 linked publications.
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 17 Feb 2021.