NCT04757454

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

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

September 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

1.2 years

First QC Date

February 8, 2021

Last Update Submit

February 12, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Health adverse outcomes based on the screening and diagnosis of sarcopenia as recommended by the EWGSOP2

    1-year follow-up

Interventions

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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • SARC-F unavailable
  • Unwilling to collaborate in the sarcopenia assessment
  • Unwilling to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brugmann university hospital

Brussels, 1020, Belgium

Location

Related Publications (4)

  • 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.

    PMID: 31233072BACKGROUND
  • Piotrowicz 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.

    PMID: 33506313BACKGROUND
  • 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.

    PMID: 31789867BACKGROUND
  • 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.

    PMID: 30312372BACKGROUND

MeSH Terms

Conditions

SarcopeniaHypersensitivityFrailty

Condition Hierarchy (Ancestors)

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

Study Officials

  • Murielle Surquin

    Head of the Geriatrics Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Internal Medicine and Geriatrics Department

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 17, 2021

Study Start

September 1, 2019

Primary Completion

November 11, 2020

Study Completion

November 11, 2020

Last Updated

February 17, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations