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

Sarcopenia Clinical Trial

— STRAS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04827758
• Other study ID #: GHRMSA 1094
• Secondary ID: IDRCB 2020-A0236
• Status: Terminated
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: September 23, 2022

Study information

• Verified date: October 2022
• Source: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: September 23, 2022
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Procedure:
• Screening 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.

Locations

Country	Name	City	State
France	GHRMSA - Hôpital Emile MULLER	Mulhouse

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensitivity, specificity, positive and negative predictive value of the SARC-F questionnaire		Enrollment
Secondary	Characteristics of sarcopenic patients hospitalized in each follow-up care and rehabilitation unit (i.e. day hospital, full hospitalization)		Enrollment
Secondary	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.	Hospital discharge assessed up to 3 months
Secondary	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.	Hospital discharge assessed up to 3 months
Secondary	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.	Hospital discharge assessed up to 3 months
Secondary	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.	Hospital discharge assessed up to 3 months
Secondary	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.	Hospital discharge assessed up to 3 months
Secondary	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.	Hospital discharge assessed up to 3 months