SarcopeniaSARCORSICANCT02486185
SARCORSICA: SARC-F Questionnaire as a Screening Tool for Age-related Sarcopenia
A study testing SCREENING TEST in people with Sarcopenia, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
Background to the research: Sarcopenia is a geriatric syndrome defined by progressive generalised loss of skeletal muscle, mass, force and function. Problem statement and objectives: To validate a simple, reproducible, screening tool, which is easy to use in the general practitioner's surgery is one of the challenges… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- SCREENING TEST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Nov 2014to 10 Jun 2016
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men or women who are 65-year old or older consulting a general practitioner, regardless of initial reason for the consultation.
- Patients agreeing to take part in the study after clear, true and appropriate information has been provided, giving their signed consent and having been given by hand a patient information sheet.
Who cannot join
- Patients with cognitive disorders suffering from major incapacity making understanding the study or signing the informed consent impossible.
- Patients not affiliated to a Social Security system.
- Patients suffering from acute functional problems interfering with the tests being performed (incapacity, malformation of the arm, plaster or splint).
- Patients institutionalised in nursing homes or subacute care
- Patients who use a technical aid for walking, unless this aid is a walking stick
- Patients not being followed up in a general practitioner's surgery (absence of information required to carry out the analytical part)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Cabinet de Médecine Générale
Cozzano, Corsica, 20148
Cabinet de médecine générale
Peri, Corsica, 20167
About this study
Official title: Evaluation of the SARC-F Questionnaire, a New Screening Tool for Sarcopenia in People 65-year Old and Older in the Community
Background to the research: Sarcopenia is a geriatric syndrome defined by progressive generalised loss of skeletal muscle, mass, force and function.
Problem statement and objectives: To validate a simple, reproducible, screening tool, which is easy to use in the general practitioner's surgery is one of the challenges of the future.
Read more
The primary objective is to assess the sensitivity and specificity of the study screening test, the SARC-F, at a predetermined threshold of >= 4. A total score of >=4 is associated with poor physical performance and is also predictive of the clinical diagnosis of the disease. The secondary objectives are to assess the prevalence of sarcopenia in the study population, to carry out a subgroup analysis of statistical performance for the five questions tested by the SARC-F, to identify the main risk factors associated with the disease and to propose an algorithm, positioning the SARC-F at the heart of a systematic screening process for the disease.
Materials and methods: This is a diagnostic, cross-sectional study with a descriptive and analytical epidemiological component to analyse the secondary endpoints. It will be carried out in usual care over a period of 6 months in a homogeneous population of 65-year-old and older patients from the community consulting in primary care. The subjects will undergo the screening test (SARC-F questionnaire) and then the reference clinical assessment (gold standard) in succession.
Expected results: To demonstrate the statistical tests that the SARC-F questionnaire is a simple tool, appropriate for early screening of sarcopenia in primary care.
Read the detailed description
Background to the research: Sarcopenia is a multifactorial geriatric syndrome with a prevalence ranging between 1 and 29% depending on age. It is defined by progressive, generalised loss of skeletal muscle, mass, force and function.
Problem statement and objectives: To confirm a simple, reproducible, screening tool, which is easy to use in the general practitioner's surgery is one of the challenges of the future.
The primary objective is to assess the sensitivity and specificity of the study screening test, the SARC-F, at a predetermined threshold of >=4 and to change this threshold using a ROC curve to attempt to increase its sensitivity. This questionnaire has been shown to provide low sensitivity (4%-10%) but high specificity (94%-99%) in the study carried out by Woo and co-workers on an analysis of statistical performance of the questionnaire, stratified by sex. A total score of >= 4 is associated with poor physical performance and is also predictive of the clinical diagnosis of the disease. The test will be assessed compared to the clinical diagnosis of the disease using international criteria recognised by EWGSOP, which defines sarcopenia as a reduction in muscle mass, associated with a reduction in muscle force and/or reduced physical performance by the subject. The secondary objectives are to assess the prevalence of sarcopenia in the study population, to carry out a sub-group analysis of the statistical performance of the five questions tested by the SARC-F and to identify the main risk factors associated with the disease and finally to propose an algorithm positioning the SARC-F at the heart of a systematic screening process for the disease.
Materials and Methods: This is a diagnostic, cross-sectional study with a descriptive and analytical epidemiological component to analyse the secondary end points. It will be carried out in usual care over a period of 6 months. The study will be conducted in Southern Corsica in a homogeneous population of 65 year old and older patients from the community, consulting in primary care. The number of subjects required is calculated for a disease prevalence set at 15%, a 95% specificity for the screening test with a minimum acceptable confidence interval of 80%. A total of 366 patients will therefore need to be included. The subjects will undergo the screening test (SARC-F questionnaire) and then the reference clinical assessment (gold standard) in succession). Muscle force will be assessed using a dynamometer, physical performance by a 4-metre gait test and brachial muscle circumference (BMC) will be calculated from two simple anthropometric measurements, the tricipital skin fold thickness (TS) and the brachial perimeter (BP).
Expected results: To demonstrate the statistical tests that the SARC-F questionnaire is a simple tool, appropriate for early screening of sarcopenia in primary care; to define a new optimal threshold achieving greater sensitivity, to make practitioners aware of screening for sarcopenia, to improve its prevention and to promote its management as early as possible.
- Conditions
- Sarcopenia
- Being tested
- SCREENING TEST
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCREENING TESTOther
- Skeletal muscle mass, which will be estimated by calculating values for the mid-arm muscle circumference (MAMC) from brachial perimeter (BP) and triceps skinfold thickness (TSF).
- Muscle force will be measured using a hydraulic dynamometer
- Physical performance will be estimated from the subject's Gait speed using a 4 meter gait test (Gait speed 4-m)
| Study group | Role | What they receive |
|---|---|---|
| SARC-F | Other | screening test for sarcopenia being studied, the SARC-F Receives: Other: SCREENING TEST |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire SARC-F
Measured: thirty minutes
Secondary outcomes (1)
number of participant
Measured: thirty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study start16 Nov 2014
- Primary completion10 Jun 2016
- Study completion10 Jun 2016
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.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane M SCHNEIDER, Principal investigator, schneider.s@chu-nice.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486185
- Sponsor's protocol ID
- 14-PP-19
- Acronym
- SARCORSICA
- Status last verified
- Feb 2018
- First submitted
- 1 Apr 2015
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the SARC-F Questionnaire, a New Screening Tool for Sarcopenia in People 65-year Old and Older in the Community
- ClinicalTrials.gov ID
- NCT02486185
- Acronym / sponsor ID
- SARCORSICA / 14-PP-19
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 16 Nov 2014 (actual)
- Primary completion
- 10 Jun 2016 (actual)
- Study completion
- 10 Jun 2016 (actual)
- First posted
- 1 Jul 2015 (estimated)
- 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.
Background to the research: Sarcopenia is a geriatric syndrome defined by progressive generalised loss of skeletal muscle, mass, force and function.
Problem statement and objectives: To validate a simple, reproducible, screening tool, which is easy to use in the general practitioner's surgery is one of the challenges of the future.
The primary objective is to assess the sensitivity and specificity of the study screening test, the SARC-F, at a predetermined threshold of >= 4. A total score of >=4 is associated with poor physical performance and is also predictive of the clinical diagnosis of the disease. The secondary objectives are to assess the prevalence of sarcopenia in the study population, to carry out a subgroup analysis of statistical performance for the five questions tested by the SARC-F, to identify the main risk factors associated with the disease and to propose an algorithm, positioning the SARC-F at the heart of a systematic screening process for the disease.
Materials and methods: This is a diagnostic, cross-sectional study with a descriptive and analytical epidemiological component to analyse the secondary endpoints. It will be carried out in usual care over a period of 6 months in a homogeneous population of 65-year-old and older patients from the community consulting in primary care. The subjects will undergo the screening test (SARC-F questionnaire) and then the reference clinical assessment (gold standard) in succession.
Expected results: To demonstrate the statistical tests that the SARC-F questionnaire is a simple tool, appropriate for early screening of sarcopenia in primary care.
Detailed description
Background to the research: Sarcopenia is a multifactorial geriatric syndrome with a prevalence ranging between 1 and 29% depending on age. It is defined by progressive, generalised loss of skeletal muscle, mass, force and function.
Problem statement and objectives: To confirm a simple, reproducible, screening tool, which is easy to use in the general practitioner's surgery is one of the challenges of the future.
The primary objective is to assess the sensitivity and specificity of the study screening test, the SARC-F, at a predetermined threshold of >=4 and to change this threshold using a ROC curve to attempt to increase its sensitivity. This questionnaire has been shown to provide low sensitivity (4%-10%) but high specificity (94%-99%) in the study carried out by Woo and co-workers on an analysis of statistical performance of the questionnaire, stratified by sex. A total score of >= 4 is associated with poor physical performance and is also predictive of the clinical diagnosis of the disease. The test will be assessed compared to the clinical diagnosis of the disease using international criteria recognised by EWGSOP, which defines sarcopenia as a reduction in muscle mass, associated with a reduction in muscle force and/or reduced physical performance by the subject. The secondary objectives are to assess the prevalence of sarcopenia in the study population, to carry out a sub-group analysis of the statistical performance of the five questions tested by the SARC-F and to identify the main risk factors associated with the disease and finally to propose an algorithm positioning the SARC-F at the heart of a systematic screening process for the disease.
Materials and Methods: This is a diagnostic, cross-sectional study with a descriptive and analytical epidemiological component to analyse the secondary end points. It will be carried out in usual care over a period of 6 months. The study will be conducted in Southern Corsica in a homogeneous population of 65 year old and older patients from the community, consulting in primary care. The number of subjects required is calculated for a disease prevalence set at 15%, a 95% specificity for the screening test with a minimum acceptable confidence interval of 80%. A total of 366 patients will therefore need to be included. The subjects will undergo the screening test (SARC-F questionnaire) and then the reference clinical assessment (gold standard) in succession). Muscle force will be assessed using a dynamometer, physical performance by a 4-metre gait test and brachial muscle circumference (BMC) will be calculated from two simple anthropometric measurements, the tricipital skin fold thickness (TS) and the brachial perimeter (BP).
Expected results: To demonstrate the statistical tests that the SARC-F questionnaire is a simple tool, appropriate for early screening of sarcopenia in primary care; to define a new optimal threshold achieving greater sensitivity, to make practitioners aware of screening for sarcopenia, to improve its prevention and to promote its management as early as possible.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARC-F | Other | Other: SCREENING TESTscreening test for sarcopenia being studied, the SARC-F |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Men or women who are 65-year old or older consulting a general practitioner, regardless of initial reason for the consultation.
- Patients agreeing to take part in the study after clear, true and appropriate information has been provided, giving their signed consent and having been given by hand a patient information sheet.
Key exclusion criteria (6 listed)
- Patients with cognitive disorders suffering from major incapacity making understanding the study or signing the informed consent impossible.
- Patients not affiliated to a Social Security system.
- Patients suffering from acute functional problems interfering with the tests being performed (incapacity, malformation of the arm, plaster or splint).
- Patients institutionalised in nursing homes or subacute care
- Patients who use a technical aid for walking, unless this aid is a walking stick
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 TEST* Skeletal muscle mass, which will be estimated by calculating values for the mid-arm muscle circumference (MAMC) from brachial perimeter (BP) and triceps skinfold thickness (TSF). * Muscle force will be measured using a hydraulic dynamometer * Physical performance will be estimated from the subject's Gait speed using a 4 meter gait test (Gait speed 4-m) | Other | SARC-F |
Primary outcome
questionnaire SARC-F
Time frame: thirty minutes
1 secondary outcome
number of participant
Time frame: thirty minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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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.
Stéphane M SCHNEIDER principal investigator
schneider.s@chu-nice.fr
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCREENING TEST in people with Sarcopenia, run by Centre Hospitalier Universitaire de Nice at 2 sites 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
questionnaire SARC-F (time frame: thirty minutes). 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 19 Feb 2018.