SarcopeniaCHRONOS-SARCNCT04987814
High-definition Surface Electromyography Markers for the Diagnosis 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 6 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 olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- HD-sEMG, - Quadriceps muscle ultrasound and IPAQ Physical Activity Questionnaire.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 6 sitesFrance
- Study dates
- 18 May 2022to 18 Dec 2026
- 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
- Healthy volunteers accepted
- 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
- Untreated/unbalanced endocrinological pathology
- Myopathy
- Inflammatory or autoimmune pathology
- 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
Show all 11Show fewer
- Patients with a very short life expectancy
- Recent fracture or trauma of the lower limbs preventing dynamic measurement of HD-sEMG recording
- Bilateral hip prosthesis
- Skin problem that may interfere with the recording of surface EMG activity
- Patient under guardianship / curatorship
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Service de gériatrie aigue polyvalente (GAP)
Ivry-sur-Seine, 94205
Alexandra Monti, Md, alexandra.monti@aphp.fr
- Recruiting
Service de soins de suite et de réadaptation Gériatrique 1
Ivry-sur-Seine, 94205
Cristiano DONADIO, MD, cristiano.donadio@aphp.fr
- Recruiting
Service de soins de suite et de réadaptation gériatrique 2
Ivry-sur-Seine, 94205
Adeline GOURONNEC, MD, adeline.gouronnec@aphp.fr
- Not yet recruiting
Unité d'Explorations fonctionnelles du sujet âgé, Hôpital Charles Foix
Ivry-sur-Seine, 94205
Kiyoka KINUGAWA, MD PhD, +33 1 49594750, kiyoka.kinugawa@aphp.fr
- Recruiting
Service de soins de suite et de réadaptation -Plaies et cicatrisation
Paris, 75012
Hester COLBOC, MD, hester.colboc@aphp.fr
- Recruiting
Service de soins de suite et de réadaptation Gériatrique Hôpital Rothschild
Paris, 75012
Charlotte TOMEO, MD, charlotte.tomeo@aphp.fr
About this study
Official title: HD-sEMG Markers of Sarcopenia
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 pilot project, the investigators want to explore the potential of the high-definition surface electromyography technology (HD-sEMG) for the diagnosis of sarcopenia.
Read more
This is a monocentric, descriptive, cross-sectional, parallel group study to develop a new diagnostic method.
It is planned to include 50 people aged 75 years and over hospitalized in the acute geriatric ward and suspected of sarcopenia (Score ≥4 on the SARC-F screening questionnaire).
The inclusion duration will be 36 months and adding a 1-month patient follow-up as part of routine care, the total study duration will be 37 months.
Patients will have their body composition (muscle mass, fat mass, and bone mass) using 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 pilot project, the investigators aim to develop a medical device 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, Biphotonic X-ray absorptiometry, Dual x-ray absorptiometry (DEXA)
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-sEMGOther
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 lifts, depending on the patient's functional state.
- Quadriceps muscle ultrasoundOther
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.Other
physical activity assessment questionnaire/adapted version for seniors
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients suspected of sarcopenia | Experimental | Not described Receives: Other: HD-sEMG; Other: - 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.
Electromyographic signals of the rectus femoris collected by the HD-sEMG technique
These signals will be confronted by the diagnosis of sarcopenia defined by the joint presence of the 2 clinical criteria of the European Working Group on Sarcopenia in Older People 2 (EWGSOP2).
Measured: day1-day7
Secondary outcomes (7)
Number of participants with falls. Definition of " fallers " : at least 1 fall in the last 12 months
Information will be collected in the medical record.
Measured: day1- day7
Skeletal muscle mass index (SMMI in kg/m2, skeletal muscle mass/height2) collected by DEXA
Measured: day1-day7
Grip strength by dynamometer (kg)
Measured: day1-day7
SPPB score (SHORT PHYSICAL PERFORMANCE BATTERY score)
Short Physical Performance Battery (SPPB): score range 0-12, higher score means a better outcome
Measured: day1-day7
HD-sEMG muscle data, measured during lower limb quadriceps extension by High Definition Surface Electromyography HD-sEMG
HD-sEMG parameters will be collected by HD-sEMG technique with TMSi's Mobita equipment, CE marked (European compliance). They will be collected by electrical measurements from a grid of electrodes (32 channels) placed on the muscle surface. The results of the measurement will be represented by a muscle activation mapping.
Measured: 1 month post inclusion
Rate of Mortality at 1 month
Rate of participants who deceased at 1 month. Mortality will be measured with vital status at 1 month.
Measured: 1 month post inclusion
Muscle and subcutaneous fat thicknesses of the quadriceps in mm
Muscle and subcutaneous fat thickness of the quadriceps in mm evaluated by ultrasound
Measured: day1-day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start18 May 2022
- Primary completion18 Nov 2026 (estimated)
- Study completion18 Dec 2026 (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
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kiyoka KINUGAWA, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987814
- Sponsor's protocol ID
- APHP201339
- Acronym
- CHRONOS-SARC
- Status last verified
- May 2025
- First submitted
- 29 Apr 2021
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request 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 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HD-sEMG Markers of Sarcopenia
- ClinicalTrials.gov ID
- NCT04987814
- Acronym / sponsor ID
- CHRONOS-SARC / APHP201339
- Conditions
- Sarcopenia
- Keywords
- High definition surface electromyography, Sarcopenia, Muscle, Biphotonic X-ray absorptiometry, Dual x-ray absorptiometry (DEXA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 18 Nov 2026 (estimated)
- Study completion
- 18 Dec 2026 (estimated)
- First posted
- 3 Aug 2021 (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 pilot project, the investigators want to explore the potential of the high-definition surface electromyography technology (HD-sEMG) for the diagnosis of sarcopenia.
This is a monocentric, descriptive, cross-sectional, parallel group study to develop a new diagnostic method.
It is planned to include 50 people aged 75 years and over hospitalized in the acute geriatric ward and suspected of sarcopenia (Score ≥4 on the SARC-F screening questionnaire).
The inclusion duration will be 36 months and adding a 1-month patient follow-up as part of routine care, the total study duration will be 37 months.
Patients will have their body composition (muscle mass, fat mass, and bone mass) using 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 pilot project, the investigators aim to develop a medical device 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 | Other: HD-sEMG, Other: - Quadriceps muscle ultrasound, Other: IPAQ Physical Activity Questionnaire. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- 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 (11 listed)
- BMI ≥30 kg/m2
- Untreated/unbalanced endocrinological pathology
- Myopathy
- Inflammatory or autoimmune pathology
- Severe psychiatric pathology or severe cognitive disorders that do not allow the performance of examinations
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 lifts, depending on the patient's functional state. | Other | 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. | Other | Elderly patients suspected of sarcopenia |
| IPAQ Physical Activity Questionnaire.physical activity assessment questionnaire/adapted version for seniors | Other | Elderly patients suspected of sarcopenia |
Primary outcome
Electromyographic signals of the rectus femoris collected by the HD-sEMG technique
Time frame: day1-day7
These signals will be confronted by the diagnosis of sarcopenia defined by the joint presence of the 2 clinical criteria of the European Working Group on Sarcopenia in Older People 2 (EWGSOP2).
7 secondary outcomes
Number of participants with falls. Definition of " fallers " : at least 1 fall in the last 12 months
Time frame: day1- day7
Skeletal muscle mass index (SMMI in kg/m2, skeletal muscle mass/height2) collected by DEXA
Time frame: day1-day7
Grip strength by dynamometer (kg)
Time frame: day1-day7
SPPB score (SHORT PHYSICAL PERFORMANCE BATTERY score)
Time frame: day1-day7
HD-sEMG muscle data, measured during lower limb quadriceps extension by High Definition Surface Electromyography HD-sEMG
Time frame: 1 month post inclusion
Rate of Mortality at 1 month
Time frame: 1 month post inclusion
Muscle and subcutaneous fat thicknesses of the quadriceps in mm
Time frame: day1-day7
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 23 May 2025.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request 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.
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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.
Kiyoka KINUGAWA, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
6 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 6 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 11 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 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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, 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?
Electromyographic signals of the rectus femoris collected by the HD-sEMG technique (time frame: day1-day7). 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 23 May 2025.