SarcopeniaSTRASNCT04827758
Evaluation of a Screening Strategy for Sarcopenia: a Monocentric Prospective Cohort Study (STRAS)
A study testing Screening and diagnostic tests for sarcopenia in people with Sarcopenia, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Screening and diagnostic tests for sarcopenia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2021to 23 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Screening Strategy for Sarcopenia: a Monocentric Prospective Cohort Study
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
- 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.
- Conditions
- Sarcopenia
- Being tested
- Screening and diagnostic tests for sarcopenia
- Keywords
- sarcopenia, muscle strength, muscle mass, older people
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening and diagnostic tests for sarcopeniaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalized in the follow-up care and rehabilitation units | Other | Not described Receives: Procedure: Screening and diagnostic tests for sarcopenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment
Secondary outcomes (8)
Sensitivity, specificity, positive and negative predictive value of the SARC-F questionnaire
Measured: Enrollment
Characteristics of sarcopenic patients hospitalized in each follow-up care and rehabilitation unit (i.e. day hospital, full hospitalization)
Measured: Enrollment
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.
Measured: Hospital discharge assessed up to 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.
Measured: Hospital discharge assessed up to 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.
Measured: Hospital discharge assessed up to 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.
Measured: Hospital discharge assessed up to 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.
Measured: Hospital discharge assessed up to 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.
Measured: Hospital discharge assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start22 Apr 2021
- Primary completion23 Sep 2022
- Study completion23 Sep 2022
Why it stopped: insufficient recruitment to meet the objectives in time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier SIRLIN, MD, Principal investigator, Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827758
- Sponsor's protocol ID
- GHRMSA 1094
- Other IDs
- IDRCB 2020-A02364-35
- Acronym
- STRAS
- Status last verified
- Oct 2022
- First submitted
- 24 Mar 2021
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Screening Strategy for Sarcopenia: a Monocentric Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04827758
- Acronym / sponsor ID
- STRAS / GHRMSA 1094
- Conditions
- Sarcopenia
- Keywords
- sarcopenia, muscle strength, muscle mass, older people
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment to meet the objectives in time
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalized in the follow-up care and rehabilitation units | Other | Procedure: Screening and diagnostic tests for sarcopenia |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening and diagnostic tests for sarcopeniaAll 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. | Procedure or surgery | Patients hospitalized in the follow-up care and rehabilitation units |
Primary outcome
Number of patients with sarcopenia
Time frame: Enrollment
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.
8 secondary outcomes
Sensitivity, specificity, positive and negative predictive value of the SARC-F questionnaire
Time frame: Enrollment
Characteristics of sarcopenic patients hospitalized in each follow-up care and rehabilitation unit (i.e. day hospital, full hospitalization)
Time frame: Enrollment
Muscle strength
Time frame: Hospital discharge assessed up to 3 months
Muscle mass
Time frame: Hospital discharge assessed up to 3 months
4-meter walking speed test
Time frame: Hospital discharge assessed up to 3 months
Timed-Up and Go test (TUG)
Time frame: Hospital discharge assessed up to 3 months
ADL (Activities of Daily Living) questionnaire
Time frame: Hospital discharge assessed up to 3 months
IADL (Instrumental Activities of Daily Living) questionnaire
Time frame: Hospital discharge assessed up to 3 months
Results and safety
The study was stopped early (reason given: insufficient recruitment to meet the objectives in time). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier SIRLIN, MD principal investigator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening and diagnostic tests for sarcopenia in people with Sarcopenia, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment to meet the objectives in time). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with sarcopenia (time frame: Enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.