Clinical trial NCT04827758: Evaluation of a Screening Strategy for Sarcopenia: a Monocentric Prospective Cohort Study (STRAS)
Official title: Evaluation of a Screening Strategy for Sarcopenia: a Monocentric Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sarcopenia
Keywords: sarcopenia
muscle strength
muscle mass
older people
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 15
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with sarcopenia
timeFrame: Enrollment
Secondary outcomes:
measure: Sensitivity, specificity, positive and negative predictive value of the SARC-F questionnaire
timeFrame: Enrollment
measure: Characteristics of sarcopenic patients hospitalized in each follow-up care and rehabilitation unit (i.e. day hospital, full hospitalization)
timeFrame: Enrollment
measure: Muscle strength
timeFrame: Hospital discharge assessed up to 3 months
measure: Muscle mass
timeFrame: Hospital discharge assessed up to 3 months
measure: 4-meter walking speed test
timeFrame: Hospital discharge assessed up to 3 months
measure: Timed-Up and Go test (TUG)
timeFrame: Hospital discharge assessed up to 3 months
measure: ADL (Activities of Daily Living) questionnaire
timeFrame: Hospital discharge assessed up to 3 months
measure: IADL (Instrumental Activities of Daily Living) questionnaire
timeFrame: Hospital discharge assessed up to 3 months
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: GHRMSA - Hôpital Emile MULLER
Study officials:
affiliation: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
name: Xavier SIRLIN, MD
role: PRINCIPAL_INVESTIGATOR
References: