High-definition Surface Electromyography Markers for the Diagnosis of Sarcopenia

Last updated: August 19, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcopenia

Treatment

- Quadriceps muscle ultrasound

HD-sEMG

IPAQ Physical Activity Questionnaire.

Clinical Study ID

NCT04987814
APHP201339
  • Ages > 75
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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

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 theperformance 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 ofHD-sEMG recording

  • Bilateral hip prosthesis

  • Skin problem that may interfere with the recording of surface EMG activity

  • Patient under guardianship / curatorship

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: - Quadriceps muscle ultrasound
Phase:
Study Start date:
May 18, 2022
Estimated Completion Date:
June 18, 2025

Study 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.

Connect with a study center

  • Service de soins de suite et de réadaptation Gériatrique 1

    Ivry sur Seine, 94205
    France

    Active - Recruiting

  • Service de gériatrie aigue polyvalente (GAP)

    Ivry-sur-Seine, 94205
    France

    Active - Recruiting

  • Service de soins de suite et de réadaptation gériatrique 2

    Ivry-sur-Seine, 94205
    France

    Active - Recruiting

  • Unité d'Explorations fonctionnelles du sujet âgé, Hôpital Charles Foix

    Ivry-sur-Seine, 94205
    France

    Site Not Available

  • Service de soins de suite et de réadaptation -Plaies et cicatrisation

    Paris, 75012
    France

    Active - Recruiting

  • Service de soins de suite et de réadaptation Gériatrique Hôpital Rothschild

    Paris, 75012
    France

    Active - Recruiting

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