High-definition Surface Electromyography Markers for the Diagnosis and Monitoring of Sarcopenia
CHRONOSSARCRE
Preventing Loss of Autonomy in Older Patients by Improving Diagnosis of Sarcopenia and Monitoring With High-definition Surface Electromyography Technology
1 other identifier
interventional
846
1 country
11
Brief Summary
Sarcopenia is a progressive and generalised skeletal muscle disorder involving the accelerated loss of muscle mass and function that is associated with increased adverse outcomes including falls, functional decline, frailty, and mortality. In this project, the high-definition surface electromyography technology (HD-sEMG) signals will be analysed to extract features/ markers for the diagnosis of sarcopenia. This is a multicentric, descriptive, cross-sectional, parallel group study to develop a new diagnostic method. It is planned to include 846 people aged 75 years and over hospitalized in the acute geriatric or rehabilitation wards and suspected of sarcopenia (Score ≥4 on the SARC-F screening questionnaire). The inclusion duration will be 18 months and adding a 3-month patient follow-up. The total study duration will be 21 months. Patients will have their body composition using bioimpedancemetry and if possible by dual X-ray absorptiometry (DEXA). Muscular strength will be assessed by handgrip strength. Physical performance will be assessed. Additional data will be collected from their medical records.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2025
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2024
CompletedFirst Posted
Study publicly available on registry
May 9, 2025
CompletedStudy Start
First participant enrolled
July 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
February 13, 2026
February 1, 2026
1.6 years
January 12, 2024
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic score of electromyographic signals from the rectus femoris collected by the HD-sEMG technique, differentiating sarcopenic from non-sarcopenic elderly subjects
Day 1- Day 7
Secondary Outcomes (15)
HD-sEMG signals associated with functional recovery
Day 21 +/-3 days
HD-sEMG signals associated with functional recovery
Day 90+/-7 days
HD-sEMG signals associated with Muscle Mass Index
Day 1
HD-sEMG signals associated with Muscle Mass Index
Day 7
HD-sEMG signals associated with grip strength
Day 1
- +10 more secondary outcomes
Study Arms (1)
Elderly patients suspected of sarcopenia
EXPERIMENTALInterventions
High definition surface electromyography, allowing the recording of muscle activation signals sensitive to the intensity of the contraction and indirectly to the muscle strength as well as to the muscular fatigability, but also capable of measuring the modifications of the recruitment modalities of the motor units. This recording will be made on the rectus femoris during knee extension, either in the lying position or during chair rises, depending on the patient's functional state
Muscle Ultrasound with Philips Lumify Wireless Handheld Ultrasound for Android - Model - L12-4 linear probe, allowing performance at the patient's bed
Physical activity assessment questionnaire/adapted version for seniors
Eligibility Criteria
You may qualify if:
- Patient aged 75 years and over
- Score ≥4 on the SARC-F screening questionnaire
- Enrolled in a social security plan (no AME)
- Informed and consenting patient
You may not qualify if:
- BMI ≥30 kg/m2
- Severe psychiatric pathology or severe cognitive disorders that do not allow the performance of examinations
- Patients who are dependent for all acts of daily life
- Patients with a very short life expectancy \<3months
- Pace maker
- Recent fracture or trauma of the preventing dynamic measurement of HD-sEMG recording
- Bilateral hip prosthesis
- Skin problem that may interfere with the recording of surface EMG activity
- Skin allergies to plasters
- Allergies to electrode materials (acrylate)
- Patient under legal protection
- Patient on state medical aid (AME : Aide Médicale d'Etat)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Hôpital Corentin Celton, APHP
Issy-les-Moulineaux, 92130, France
Hôpital Corentin Celton, APHP
Issy-les-Moulineaux, 92130, France
Hôpital Charles Foix, APHP
Ivry-sur-Seine, 94205, France
Hôpital Charles Foix, APHP
Ivry-sur-Seine, 94205, France
Hôpital Charles Foix, APHP
Ivry-sur-Seine, 94205, France
Unité d'Explorations fonctionnelles du sujet âgé - Hôpital Charles Foix
Ivry-sur-Seine, 94205, France
Hôpital Rothschild, APHP
Paris, 75012, France
Hôpital Rothschild, APHP
Paris, 75012, France
Hôpital Saint-Antoine, APHP
Paris, 75012, France
Hôpital Bichat, APHP
Paris, 75018, France
Hôpital Tenon, APHP
Paris, 75020, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
January 12, 2024
First Posted
May 9, 2025
Study Start
July 9, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal.
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.