Evaluation of a Screening Strategy for Sarcopenia: a Monocentric Prospective Cohort Study (STRAS) (STRAS)
Primary Purpose
Sarcopenia
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Screening and diagnostic tests for sarcopenia
Sponsored by
About this trial
This is an interventional diagnostic trial for Sarcopenia focused on measuring sarcopenia, muscle strength, muscle mass, older people
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.
Sites / Locations
- GHRMSA - Hôpital Emile MULLER
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients hospitalized in the follow-up care and rehabilitation units
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Sensitivity, specificity, positive and negative predictive value of the SARC-F questionnaire
Characteristics of sarcopenic patients hospitalized in each follow-up care and rehabilitation unit (i.e. day hospital, full hospitalization)
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04827758
First Posted
March 24, 2021
Last Updated
October 27, 2022
Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
1. Study Identification
Unique Protocol Identification Number
NCT04827758
Brief Title
Evaluation of a Screening Strategy for Sarcopenia: a Monocentric Prospective Cohort Study (STRAS)
Acronym
STRAS
Official Title
Evaluation of a Screening Strategy for Sarcopenia: a Monocentric Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
insufficient recruitment to meet the objectives in time
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
September 23, 2022 (Actual)
Study Completion Date
September 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
To assess the performance of the SARC-F questionnaire to screen for sarcopenia ;
To describe the characteristics of sarcopenic patients hospitalized in each follow-up care and rehabilitation unit (i.e. day hospital, full hospitalization);
To identify predictive factors of sarcopenia;
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 :
muscle strength,
muscle mass,
functional ability,
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
sarcopenia, muscle strength, muscle mass, older people
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients hospitalized in the follow-up care and rehabilitation units
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Screening and diagnostic tests for sarcopenia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients with sarcopenia
Description
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 Outcome Measure Information:
Title
Sensitivity, specificity, positive and negative predictive value of the SARC-F questionnaire
Time Frame
Enrollment
Title
Characteristics of sarcopenic patients hospitalized in each follow-up care and rehabilitation unit (i.e. day hospital, full hospitalization)
Time Frame
Enrollment
Title
Muscle strength
Description
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
Title
Muscle mass
Description
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
Title
4-meter walking speed test
Description
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
Title
Timed-Up and Go test (TUG)
Description
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
Title
ADL (Activities of Daily Living) questionnaire
Description
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
Title
IADL (Instrumental Activities of Daily Living) questionnaire
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier SIRLIN, MD
Organizational Affiliation
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Official's Role
Principal Investigator
Facility Information:
Facility Name
GHRMSA - Hôpital Emile MULLER
City
Mulhouse
ZIP/Postal Code
68100
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Screening Strategy for Sarcopenia: a Monocentric Prospective Cohort Study (STRAS)
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