High-definition Surface Electromyography Markers for the Diagnosis and Monitoring of Sarcopenia

NCT ID: NCT06963359

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 846 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-09
• Study Completion Date: 2027-03-31

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.

Detailed Description

The aging of the population is a major public health problem with its multifactorial impact on quality of life and maintenance of autonomy. Unfortunately, one consequence of aging is sarcopenia, which affects the intrinsic and functional properties of muscle. It is a risk factor for loss of autonomy, falls, frailty and is associated with increased mortality. Sarcopenia is defined as a progressive loss of muscle mass, strength and physical performance. Classically, sarcopenia is assessed by imaging techniques (MRI, DEXA) or bioelectrical impedancemetry for aspects related to the assessment of muscle mass loss. MRI or DEXA are not widely available and/or access is limited. For functional aspects, grip strength measurements are often used. Currently sarcopenia cannot be diagnosed and evaluated by a single examination, including both the morphological (muscle mass) and functional aspects. Furthermore, several biological markers are associated with muscle mass, strength, and function, but these biomarkers are not specific to skeletal muscle and are weakly associated with clinical goals. Finally, despite the important interest in assessing the qualitative/functional and quantitative aspect of skeletal muscle in neuromuscular impairment, there is currently no tool that routinely assesses these aspects. In this context, developing new approaches for non-invasive assessment of sarcopenia, is a major issue. In this project, the investigators aim to develop an automatic procedure derived from high-definition surface electromyography (HD-sEMG) technology, non-invasive and portable, for the diagnosis of sarcopenia.

Conditions

Sarcopenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Elderly patients suspected of sarcopenia

Group Type: EXPERIMENTAL

HD-sEMG

Intervention Type: DEVICE

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

Quadriceps muscle ultrasound

Intervention Type: DEVICE

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

IPAQ Physical Activity Questionnaire

Intervention Type: OTHER

Physical activity assessment questionnaire/adapted version for seniors

Interventions

HD-sEMG

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

Intervention Type: DEVICE

Quadriceps muscle ultrasound

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

Intervention Type: DEVICE

IPAQ Physical Activity Questionnaire

Physical activity assessment questionnaire/adapted version for seniors

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Compiègne University of Technology

UNKNOWN

Sponsor Role: collaborator

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Corentin Celton, APHP

Issy-les-Moulineaux, , France

Site Status: RECRUITING

Hôpital Corentin Celton, APHP

Issy-les-Moulineaux, , France

Site Status: RECRUITING

Hôpital Charles Foix, APHP

Ivry-sur-Seine, , France

Site Status: RECRUITING

Hôpital Charles Foix, APHP

Ivry-sur-Seine, , France

Site Status: RECRUITING

Hôpital Charles Foix, APHP

Ivry-sur-Seine, , France

Site Status: RECRUITING

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

Ivry-sur-Seine, , France

Site Status: NOT_YET_RECRUITING

Hôpital Rothschild, APHP

Paris, , France

Site Status: RECRUITING

Hôpital Rothschild, APHP

Paris, , France

Site Status: RECRUITING

Hôpital Saint-Antoine, APHP

Paris, , France

Site Status: RECRUITING

Hôpital Bichat, APHP

Paris, , France

Site Status: RECRUITING

Hôpital Tenon, APHP

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Kiyoka KINUGAWA, Prof. MD PhD

Role: CONTACT

kiyoka.kinugawa@aphp.fr

+331 49 59 47 53

Sofiane BOUDAOUD, Prof. PhD

Role: CONTACT

sofiane.boudaoud@utc.fr

+(33) 03 44 23 79 29

Facility Contacts

Johanne Poisson, MD-PhD

Role: primary

johanne.poisson@aphp.fr

0158004802

Anthony Mézière, MD, PhD

Role: primary

anthony.meziere@aphp.fr

01 58 00 41 31

Alexandra Monti, MD, PhD

Role: primary

alexandra.monti@aphp.fr

01 49 59 44 91

Cristiano Donadio, MD, PhD

Role: primary

cristiano.donadio@aphp.fr

0149594584

Adeline Gouronnec, MD, PhD

Role: primary

adeline.gouronnec@aphp.fr

01 49 59 44 75

Kiyoka KINUGAWA, Prof. MD PhD

Role: primary

kiyoka.kinugawa@aphp.fr

+331 49 59 47 53

Anne-Sophie Grancher, MD-PhD

Role: primary

anne-sophie.grancher@aphp.fr

0140 19 33 94

Hester Colboc, MD-PhD

Role: primary

hester.colboc@aphp.fr

0603611623

Hélène Vallet, MD, PhD

Role: primary

helene.vallet@aphp.fr

01 49 28 20 42

Manuel Sanchez, MD, PhD

Role: primary

manuel.sanchez@aphp.fr

01 56 01 72 53

Audrey Rouet, MD-PhD

Role: primary

audrey.rouet@aphp.fr

0156017253

Other Identifiers

APHP240022

Identifier Type: -

Identifier Source: org_study_id