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Studies

Interventional Recruiting

NCT06963359 on ClinicalTrials.gov

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

Official title: Preventing Loss of Autonomy in Older Patients by Improving Diagnosis of Sarcopenia and Monitoring With High-definition Surface Electromyography Technology

  • Sponsor: Assistance Publique - Hôpitaux de Paris
  • Collaborators: Compiègne University of Technology, Centre National de la Recherche Scientifique, France
  • Enrollment: 846 (Estimated)
  • Study start: 2025-07-09 (Actual)
  • Primary completion: 2027-03-01 (Estimated)
  • Study completion: 2027-03-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Diagnostic

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.

Conditions

  • Sarcopenia

Intervention / Treatment

  • Device: HD-sEMG
  • Device: Quadriceps muscle ultrasound
  • Other: IPAQ Physical Activity Questionnaire

Primary Outcome Measures

  • 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)

Countries

France

Locations and Investigators

  • Hôpital Corentin Celton, APHP, Issy-les-Moulineaux, France (Recruiting)
    • Johanne Poisson, MD-PhD
  • Hôpital Corentin Celton, APHP, Issy-les-Moulineaux, France (Recruiting)
    • Anthony Mézière, MD, PhD
  • Hôpital Charles Foix, APHP, Ivry-sur-Seine, France (Recruiting)
    • Alexandra Monti, MD, PhD
  • Hôpital Charles Foix, APHP, Ivry-sur-Seine, France (Recruiting)
    • Cristiano Donadio, MD, PhD
  • Hôpital Charles Foix, APHP, Ivry-sur-Seine, France (Recruiting)
    • Adeline Gouronnec, MD, PhD
  • Unité d'Explorations fonctionnelles du sujet âgé - Hôpital Charles Foix, Ivry-sur-Seine, France (Not yet recruiting)
  • Hôpital Rothschild, APHP, Paris, France (Recruiting)
    • Anne-Sophie Grancher, MD-PhD
  • Hôpital Rothschild, APHP, Paris, France (Recruiting)
    • Hester Colboc, MD-PhD
  • Hôpital Saint-Antoine, APHP, Paris, France (Recruiting)
    • Hélène Vallet, MD, PhD
  • Hôpital Bichat, APHP, Paris, France (Recruiting)
    • Manuel Sanchez, MD, PhD
  • Hôpital Tenon, APHP, Paris, France (Recruiting)
    • Audrey Rouet, MD-PhD