NCT04987814 High-definition Surface Electromyography Markers for the Diagnosis of Sarcopenia
| NCT ID | NCT04987814 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Sarcopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 175 participants |
| Start Date | 2022-05-18 |
| Primary Completion | 2026-11-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 175 participants in total. It began in 2022-05-18 with a primary completion date of 2026-11-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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 * 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 * 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
Contact & Investigator
Kiyoka KINUGAWA, MD PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04987814 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Sarcopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04987814 currently recruiting?
Yes, NCT04987814 is actively recruiting participants. Contact the research team at kiyoka.kinugawa@aphp.fr for enrollment information.
Where is the NCT04987814 trial being conducted?
This trial is being conducted at Ivry-sur-Seine, France, Ivry-sur-Seine, France, Ivry-sur-Seine, France, Ivry-sur-Seine, France and 2 additional locations.
Who is sponsoring the NCT04987814 clinical trial?
NCT04987814 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Kiyoka KINUGAWA, MD PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 175 participants.