SarcopeniaCHRONOSSARCRENCT06963359
High-definition Surface Electromyography Markers for the Diagnosis and Monitoring of Sarcopenia
A study testing HD-sEMG, Quadriceps muscle ultrasound and IPAQ Physical Activity Questionnaire in people with Sarcopenia, run by Assistance Publique - Hôpitaux de Paris at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- HD-sEMG, Quadriceps muscle ultrasound and IPAQ Physical Activity Questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 846 participants
- Where
- 11 sitesFrance
- Study dates
- 9 Jul 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
Hôpital Corentin Celton, APHP
Issy-les-Moulineaux, 92130
Johanne Poisson, MD-PhD, 0158004802, johanne.poisson@aphp.fr
- Recruiting
Hôpital Corentin Celton, APHP
Issy-les-Moulineaux, 92130
Anthony Mézière, MD, PhD, 01 58 00 41 31, anthony.meziere@aphp.fr
- Recruiting
Hôpital Charles Foix, APHP
Ivry-sur-Seine, 94205
Alexandra Monti, MD, PhD, 01 49 59 44 91, alexandra.monti@aphp.fr
- Recruiting
Hôpital Charles Foix, APHP
Ivry-sur-Seine, 94205
Cristiano Donadio, MD, PhD, 0149594584, cristiano.donadio@aphp.fr
- Recruiting
Hôpital Charles Foix, APHP
Ivry-sur-Seine, 94205
Adeline Gouronnec, MD, PhD, 01 49 59 44 75, adeline.gouronnec@aphp.fr
- Not yet recruiting
Unité d'Explorations fonctionnelles du sujet âgé - Hôpital Charles Foix
Ivry-sur-Seine, 94205
Kiyoka KINUGAWA, Prof. MD PhD, +331 49 59 47 53, kiyoka.kinugawa@aphp.fr
- Recruiting
Hôpital Rothschild, APHP
Paris, 75012
Anne-Sophie Grancher, MD-PhD, 0140 19 33 94, anne-sophie.grancher@aphp.fr
- Recruiting
Hôpital Rothschild, APHP
Paris, 75012
Hester Colboc, MD-PhD, 0603611623, hester.colboc@aphp.fr
- Recruiting
Hôpital Saint-Antoine, APHP
Paris, 75012
Hélène Vallet, MD, PhD, 01 49 28 20 42, helene.vallet@aphp.fr
- Recruiting
Hôpital Bichat, APHP
Paris, 75018
Manuel Sanchez, MD, PhD, 01 56 01 72 53, manuel.sanchez@aphp.fr
- Recruiting
Hôpital Tenon, APHP
Paris, 75020
Audrey Rouet, MD-PhD, 0156017253, audrey.rouet@aphp.fr
About this study
Official title: Preventing Loss of Autonomy in Older Patients by Improving Diagnosis of Sarcopenia and Monitoring With High-definition Surface Electromyography Technology
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.
Read the 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
- Being tested
- HD-sEMG, Quadriceps muscle ultrasound, IPAQ Physical Activity Questionnaire
- Keywords
- High definition surface electromyography, Sarcopenia, Muscle
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Quadriceps muscle ultrasoundDevice
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 QuestionnaireOther
Physical activity assessment questionnaire/adapted version for seniors
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients suspected of sarcopenia | Experimental | Not described Receives: Device: HD-sEMG; Device: Quadriceps muscle ultrasound; Other: IPAQ Physical Activity Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic score of electromyographic signals from the rectus femoris collected by the HD-sEMG technique, differentiating sarcopenic from non-sarcopenic elderly subjects
Measured: Day 1- Day 7
Secondary outcomes (15)
HD-sEMG signals associated with functional recovery
Identify HD-sEMG parameters associated with good functional recovery of autonomy at D21 and M3 of hospitalization (muscle resilience)
Measured: Day 21 +/-3 days
HD-sEMG signals associated with functional recovery
Identify HD-sEMG parameters associated with good functional recovery of autonomy at D21 and M3 of hospitalization (muscle resilience)
Measured: Day 90+/-7 days
HD-sEMG signals associated with Muscle Mass Index
Correlation between electromyographic signals from the rectus femoris collected using the HD-sEMG technique and the Muscle Mass Index measured by DEXA or Bioimpedancemetry
Measured: Day 1
HD-sEMG signals associated with Muscle Mass Index
Correlation between electromyographic signals from the rectus femoris collected using the HD-sEMG technique and the Muscle Mass Index measured by DEXA or Bioimpedancemetry
Measured: Day 7
HD-sEMG signals associated with grip strength
Correlation between electromyographic signals from the rectus femoris collected using the HD-sEMG technique and grip strength measured using manual hydraulic dynamometer
Measured: Day 1
HD-sEMG signals associated with grip strength
Correlation between electromyographic signals from the rectus femoris collected using the HD-sEMG technique and grip strength measured using manual hydraulic dynamometer
Measured: Day 7
HD-sEMG signals associated with physical performance
Correlation between electromyographic signals from the rectus femoris collected using the HD-sEMG technique and the physical performance measured using Short Physical Performance Battery score (bad physical performance if score ≤ 8).
Measured: Day 1
HD-sEMG signals associated with physical performance
Correlation between electromyographic signals from the rectus femoris collected using the HD-sEMG technique and the physical performance measured using Short Physical Performance Battery score (bad physical performance if score ≤ 8).
Measured: Day 7
HD-sEMG signals associated with quadriceps muscle and subcutaneous fat thickness
Correlation between electromyographic signals from the rectus femoris collected using the HD-sEMG technique and quadriceps muscle and subcutaneous fat thickness measured using portable ultrasound).
Measured: Day 1
HD-sEMG signals associated with quadriceps muscle and subcutaneous fat thickness
Correlation between electromyographic signals from the rectus femoris collected using the HD-sEMG technique and quadriceps muscle and subcutaneous fat thickness measured using portable ultrasound).
Measured: Day 7
Progress in muscle parameters
Changes in muscle parameters mentioned above, between the D0 and D21.
Measured: Day 21 +/-3 days
Correlation between muscle parameters and in-hospital complications
Study the relationship between muscle parameters and in-hospital complications. (cardiovascular, pulmonary and thromboembolic diseases)
Measured: Day 21 +/-3 days
Correlation between muscle parameters and quality of life
Study the relationship between muscle parameters and quality of life measured using EQD5 scale (EuroQol-5D; 0-20: higher scores mean a worse outcome).
Measured: Day 1
Correlation between muscle parameters and quality of life
Study the relationship between muscle parameters and quality of life measured using EQD5 scale (EuroQol-5D; 0-20: higher scores mean a worse outcome).
Measured: Day 21 +/-3 days
Correlation between muscle parameters and quality of life
Study the relationship between muscle parameters and quality of life measured using EQD5 scale (EuroQol-5D; 0-20: higher scores mean a worse outcome).
Measured: Day 90+/-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start9 Jul 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 846 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Compiègne University of Technology, Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963359
- Sponsor's protocol ID
- APHP240022
- Acronym
- CHRONOSSARCRE
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Loss of Autonomy in Older Patients by Improving Diagnosis of Sarcopenia and Monitoring With High-definition Surface Electromyography Technology
- ClinicalTrials.gov ID
- NCT06963359
- Acronym / sponsor ID
- CHRONOSSARCRE / APHP240022
- Conditions
- Sarcopenia
- Keywords
- High definition surface electromyography, Sarcopenia, Muscle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 846 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Compiègne University of Technology, Centre National de la Recherche Scientifique, France
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients suspected of sarcopenia | Experimental | Device: HD-sEMG, Device: Quadriceps muscle ultrasound, Other: IPAQ Physical Activity Questionnaire |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HD-sEMGHigh 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 | Device | Elderly patients suspected of sarcopenia |
| Quadriceps muscle ultrasoundMuscle Ultrasound with Philips Lumify Wireless Handheld Ultrasound for Android - Model - L12-4 linear probe, allowing performance at the patient's bed | Device | Elderly patients suspected of sarcopenia |
| IPAQ Physical Activity QuestionnairePhysical activity assessment questionnaire/adapted version for seniors | Other | Elderly patients suspected of sarcopenia |
Primary outcome
Diagnostic score of electromyographic signals from the rectus femoris collected by the HD-sEMG technique, differentiating sarcopenic from non-sarcopenic elderly subjects
Time frame: Day 1- Day 7
15 secondary outcomes
HD-sEMG signals associated with functional recovery
Time frame: Day 21 +/-3 days
HD-sEMG signals associated with functional recovery
Time frame: Day 90+/-7 days
HD-sEMG signals associated with Muscle Mass Index
Time frame: Day 1
HD-sEMG signals associated with Muscle Mass Index
Time frame: Day 7
HD-sEMG signals associated with grip strength
Time frame: Day 1
HD-sEMG signals associated with grip strength
Time frame: Day 7
HD-sEMG signals associated with physical performance
Time frame: Day 1
HD-sEMG signals associated with physical performance
Time frame: Day 7
HD-sEMG signals associated with quadriceps muscle and subcutaneous fat thickness
Time frame: Day 1
HD-sEMG signals associated with quadriceps muscle and subcutaneous fat thickness
Time frame: Day 7
Progress in muscle parameters
Time frame: Day 21 +/-3 days
Correlation between muscle parameters and in-hospital complications
Time frame: Day 21 +/-3 days
Correlation between muscle parameters and quality of life
Time frame: Day 1
Correlation between muscle parameters and quality of life
Time frame: Day 21 +/-3 days
Correlation between muscle parameters and quality of life
Time frame: Day 90+/-7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD-sEMG, Quadriceps muscle ultrasound and IPAQ Physical Activity Questionnaire in people with Sarcopenia, run by Assistance Publique - Hôpitaux de Paris at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kiyoka KINUGAWA, Prof. MD PhD (+331 49 59 47 53, kiyoka.kinugawa@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic score of electromyographic signals from the rectus femoris collected by the HD-sEMG technique, differentiating sarcopenic from non-sarcopenic elderly subjects (time frame: Day 1- Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.