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TerminatedNCT04827758STRASUpdated Oct 28, 2022

Evaluation of a Screening Strategy for Sarcopenia: a Monocentric Prospective Cohort Study (STRAS)

An interventional study of Screening and diagnostic tests for sarcopenia in Sarcopenia, sponsored by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace. Terminated at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2022-10-28.

Sponsored by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace · Not applicable, Interventional, and Diagnostic

Why this study was terminated
insufficient recruitment to meet the objectives in time
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Study 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.

Read the detailed description

Secondary objectives

  1. To assess the performance of the SARC-F questionnaire to screen for sarcopenia ;
  2. To describe the characteristics of sarcopenic patients hospitalized in each follow-up care and rehabilitation unit (i.e. day hospital, full hospitalization);
  3. To identify predictive factors of sarcopenia;
  4. To determine, in the subgroup of patients hospitalized in the conventional follow-up care and rehabilitation unit (i.e. full hospitalization), the evolution of sarcopenia between admission and discharge of the following variables :

    1. muscle strength,
    2. muscle mass,
    3. functional ability,
    4. dependency.

Conduct of research

After receiving the written consent of the study participant, 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.

For patients in day hospital care, the study will end upon completion of these tests.

For patients hospitalized in the conventional follow-up care and rehabilitation unit (i.e. full hospitalization), a follow-up visit will be scheduled within 72 hours prior to the patient's discharge from the service, or at 3 months of hospitalization. The following tests and questionnaires will be performed during this visit:

  • measurement of muscle strengh by a grip test,
  • measurement of muscle mass by impedancemetry,
  • 4-meter walking speed test,
  • Timed Up and Go (TUG) test,
  • ADL and IADL questionnaires.
02

Conditions studied

  • Sarcopenia

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Keywords

  • sarcopenia
  • muscle strength
  • muscle mass
  • older people
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's enrollment of 15 is below the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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

Secondary exclusion criteria :

  • 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.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Other
    Patients hospitalized in the follow-up care and rehabilitation units

    Procedure: Screening and diagnostic tests for sarcopenia

Interventions

  • ProcedureScreening and diagnostic tests for sarcopenia

    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.

06

What researchers measure

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.

    Time frame: Enrollment

Secondary outcomes

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

    Time frame: Enrollment

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

    Time frame: Enrollment

  3. Muscle strength

    In the subgroup of patients hospitalized in the conventional follow-up care and rehabilitation unit (i.e. full hospitalization), the evolution of muscle strength between admission and discharge will be assessed by a grip test. For patients hospitalized for more than 3 months, the grip test will be performed at 3 months.

    Time frame: Hospital discharge assessed up to 3 months

  4. Muscle mass

    In the subgroup of patients hospitalized in the conventional follow-up care and rehabilitation unit (i.e. full hospitalization), the evolution of muscle mass between admission and discharge will be assessed by the measurement of the ASM/size2 (impedancemetry) ratio. For patients hospitalized for more than 3 months, the measurement of muscle mass will be performed at 3 months.

    Time frame: Hospital discharge assessed up to 3 months

  5. 4-meter walking speed test

    In the subgroup of patients hospitalized in the conventional follow-up care and rehabilitation unit (i.e. full hospitalization), the evolution of the value of the 4-meter walking speed test between admission and discharge will be assessed. For patients hospitalized for more than 3 months, the 4-meter walking speed test will be performed at 3 months.

    Time frame: Hospital discharge assessed up to 3 months

  6. Timed-Up and Go test (TUG)

    In the subgroup of patients hospitalized in the conventional follow-up care and rehabilitation unit (i.e. full hospitalization), the evolution of the value of the TUG test between admission and discharge will be assessed. For patients hospitalized for more than 3 months, the TUG test will be performed at 3 months.

    Time frame: Hospital discharge assessed up to 3 months

  7. ADL (Activities of Daily Living) questionnaire

    In the subgroup of patients hospitalized in the conventional follow-up care and rehabilitation unit (i.e. full hospitalization), the ADL questionnaire will also be performed at hospital discharge, or at 3 months for patients hospitalized for more than 3 months.

    Time frame: Hospital discharge assessed up to 3 months

  8. IADL (Instrumental Activities of Daily Living) questionnaire

    In the subgroup of patients hospitalized in the conventional follow-up care and rehabilitation unit (i.e. full hospitalization), the IADL questionnaire will also be performed at hospital discharge, or at 3 months for patients hospitalized for more than 3 months.

    Time frame: Hospital discharge assessed up to 3 months

07

Study locations

1 site
  • GHRMSA - Hôpital Emile MULLER
    Mulhouse, 68100, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04827758
Lead sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Responsible party
Sponsor
First posted
Apr 1, 2021
Start date
Apr 22, 2021
Primary completion
Sep 23, 2022
Completion
Sep 23, 2022
Last update
Oct 28, 2022

Study contacts

Xavier SIRLIN, MD
principal investigator · Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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