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

NCT02486185 | Completed

• 1 other identifier: 14-PP-19
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 2

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• questionnaire SARC-F

  thirty minutes

Secondary Outcomes (1)

• number of participant

  thirty minutes

Study Arms (1)

SARC-F

OTHER

screening test for sarcopenia being studied, the SARC-F

Other: SCREENING TEST

Interventions

SCREENING TEST OTHER

* 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)

SARC-F

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

Cabinet de Médecine Générale

Cozzano, Corsica, 20148, France

Location

Cabinet de médecine générale

Peri, Corsica, 20167, France

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Stéphane M SCHNEIDER

  schneider.s@chu-nice.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: July 1, 2015
• Study Start: November 16, 2014
• Primary Completion: June 10, 2016
• Study Completion: June 10, 2016
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

FR (2)