SARCORSICA: SARC-F Questionnaire as a Screening Tool for Age-related Sarcopenia (SARCORSICA)

February 15, 2018 updated by: Centre Hospitalier Universitaire de Nice

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
366

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Corse
      • Cozzano, Corse, France, 20148
        • Cabinet de médecine générale
      • Peri, Corse, France, 20167
        • Cabinet de médecine générale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

exclusion criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: SARC-F
screening test for sarcopenia being studied, the SARC-F
Other: 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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
questionnaire SARC-F
Time Frame: thirty minutes
thirty minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
number of participant
Time Frame: thirty minutes
thirty minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nice

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stéphane M SCHNEIDER, schneider.s@chu-nice.fr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-PP-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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