SARCORSICA: SARC-F Questionnaire as a Screening Tool for Age-related Sarcopenia (SARCORSICA)
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SCREENING TEST
Sponsored by

About this trial
This is an interventional diagnostic trial for Sarcopenia
Eligibility Criteria
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)
Sites / Locations
- Cabinet de Médecine Générale
- Cabinet de médecine générale
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SARC-F
Arm Description
screening test for sarcopenia being studied, the SARC-F
Outcomes
Primary Outcome Measures
questionnaire SARC-F
Secondary Outcome Measures
number of participant
Full Information
NCT ID
NCT02486185
First Posted
April 1, 2015
Last Updated
February 15, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT02486185
Brief Title
SARCORSICA: SARC-F Questionnaire as a Screening Tool for Age-related Sarcopenia
Acronym
SARCORSICA
Official Title
Evaluation of the SARC-F Questionnaire, a New Screening Tool for Sarcopenia in People 65-year Old and Older in the Community
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 16, 2014 (Actual)
Primary Completion Date
June 10, 2016 (Actual)
Study Completion Date
June 10, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
366 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SARC-F
Arm Type
Other
Arm Description
screening test for sarcopenia being studied, the SARC-F
Intervention Type
Other
Intervention Name(s)
SCREENING TEST
Intervention Description
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)
Primary Outcome Measure Information:
Title
questionnaire SARC-F
Time Frame
thirty minutes
Secondary Outcome Measure Information:
Title
number of participant
Time Frame
thirty minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane M SCHNEIDER
Organizational Affiliation
schneider.s@chu-nice.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cabinet de Médecine Générale
City
Cozzano
State/Province
Corse
ZIP/Postal Code
20148
Country
France
Facility Name
Cabinet de médecine générale
City
Peri
State/Province
Corse
ZIP/Postal Code
20167
Country
France
12. IPD Sharing Statement
Learn more about this trial
SARCORSICA: SARC-F Questionnaire as a Screening Tool for Age-related Sarcopenia
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