NCT04827758

Brief Summary

The main objective of this study is to determine the prevalence of sarcopenia in patients hospitalized in the follow-up care and rehabilitation units of the geriatrics department of the Mulhouse French hospital.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

March 24, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

April 22, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2022

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

1.4 years

First QC Date

March 24, 2021

Last Update Submit

October 27, 2022

Conditions

Keywords

sarcopeniamuscle strengthmuscle massolder people

Outcome Measures

Primary Outcomes (1)

  • Number of patients with sarcopenia

    The diagnosis of sarcopenia will be established according to the 2018 criteria of the European Working Group On Sarcopenia in Older People (EWGSOP2) based on the evaluation of muscle strength and muscle mass. Sarcopenia will be defined by an abnormal value measured by a grip test and confirmed by an abnormal value of the ASM/size2 ratio measured by impedancemetry.

    Enrollment

Secondary Outcomes (8)

  • Sensitivity, specificity, positive and negative predictive value of the SARC-F questionnaire

    Enrollment

  • Characteristics of sarcopenic patients hospitalized in each follow-up care and rehabilitation unit (i.e. day hospital, full hospitalization)

    Enrollment

  • Muscle strength

    Hospital discharge assessed up to 3 months

  • Muscle mass

    Hospital discharge assessed up to 3 months

  • 4-meter walking speed test

    Hospital discharge assessed up to 3 months

  • +3 more secondary outcomes

Study Arms (1)

Patients hospitalized in the follow-up care and rehabilitation units

OTHER
Procedure: Screening and diagnostic tests for sarcopenia

Interventions

All of the following tests and questionnaires will be performed : * SARC-F questionnaire, * measurement of muscle strengh by a grip test, * measurement of muscle mass by impedancemetry (ASM/size2), * 4-meter walking speed test, * Timed-Up and Go (TUG) test, * ADL (Activities of Daily Living) and IADL (Instrumental Activities of Daily Living) questionnaires.

Patients hospitalized in the follow-up care and rehabilitation units

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient 60 years of age or older
  • Patients hospitalized in the follow-up care and rehabilitation units (i.e. day hospital, full hospitalization) of the geriatrics department of the Mulhouse French hospital
  • Patient who gave consent to participate in the study
  • Affiliated or beneficiary of a social security scheme

You may not qualify if:

  • Patient admitted for palliative care
  • Bedridden patient
  • Patient with major neurocognitive disorders preventing impedancemetry or grip test from being performed, or any other medical condition preventing impedancemtery or grip test from being performed
  • Patient under legal protection
  • Patient with an unstable psychiatric disorder
  • Patient under guardianship or curatorship
  • Patient already included in the study during a previous hospitalization
  • \- For patients hospitalized in the conventional follow-up care and rehabilitation unit (i.e. full hospitalization), impedancemtry or grip test not performed within 7 days of admission.
  • Patients excluded secondarily will not be replaced.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GHRMSA - Hôpital Emile MULLER

Mulhouse, 68100, France

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Xavier SIRLIN, MD

    Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

April 1, 2021

Study Start

April 22, 2021

Primary Completion

September 23, 2022

Study Completion

September 23, 2022

Last Updated

October 28, 2022

Record last verified: 2022-10

Locations