NCT06963359

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
846

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Jul 2025

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Jul 2025Mar 2027

First Submitted

Initial submission to the registry

January 12, 2024

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

July 9, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

January 12, 2024

Last Update Submit

February 11, 2026

Conditions

Keywords

High definition surface electromyographySarcopeniaMuscle

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

EXPERIMENTAL
Device: HD-sEMGDevice: Quadriceps muscle ultrasoundOther: IPAQ Physical Activity Questionnaire

Interventions

HD-sEMGDEVICE

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

Elderly patients suspected of sarcopenia

Muscle Ultrasound with Philips Lumify Wireless Handheld Ultrasound for Android - Model - L12-4 linear probe, allowing performance at the patient's bed

Elderly patients suspected of sarcopenia

Physical activity assessment questionnaire/adapted version for seniors

Elderly patients suspected of sarcopenia

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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

RECRUITING

Hôpital Corentin Celton, APHP

Issy-les-Moulineaux, 92130, France

RECRUITING

Hôpital Charles Foix, APHP

Ivry-sur-Seine, 94205, France

RECRUITING

Hôpital Charles Foix, APHP

Ivry-sur-Seine, 94205, France

RECRUITING

Hôpital Charles Foix, APHP

Ivry-sur-Seine, 94205, France

RECRUITING

Unité d'Explorations fonctionnelles du sujet âgé - Hôpital Charles Foix

Ivry-sur-Seine, 94205, France

NOT YET RECRUITING

Hôpital Rothschild, APHP

Paris, 75012, France

RECRUITING

Hôpital Rothschild, APHP

Paris, 75012, France

RECRUITING

Hôpital Saint-Antoine, APHP

Paris, 75012, France

RECRUITING

Hôpital Bichat, APHP

Paris, 75018, France

RECRUITING

Hôpital Tenon, APHP

Paris, 75020, France

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Kiyoka KINUGAWA, Prof. MD PhD

CONTACT

Sofiane BOUDAOUD, Prof. PhD

CONTACT

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

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.

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.

Locations