跳至主要内容
临床试验/NCT06963359
NCT06963359招募中不适用

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

Assistance Publique - Hôpitaux de Paris7 个研究点 分布在 1 个国家目标入组 846 人开始时间: 2025年7月9日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
846
试验地点
7
主要终点
Diagnostic score of electromyographic signals from the rectus femoris collected by the HD-sEMG technique, differentiating sarcopenic from non-sarcopenic elderly subjects

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • 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)

研究组 & 干预措施

Elderly patients suspected of sarcopenia

Experimental

干预措施: HD-sEMG (Device)

Elderly patients suspected of sarcopenia

Experimental

干预措施: Quadriceps muscle ultrasound (Device)

Elderly patients suspected of sarcopenia

Experimental

干预措施: IPAQ Physical Activity Questionnaire (Other)

结局指标

主要结局

Diagnostic score of electromyographic signals from the rectus femoris collected by the HD-sEMG technique, differentiating sarcopenic from non-sarcopenic elderly subjects

时间窗: Day 1- Day 7

次要结局

  • HD-sEMG signals associated with functional recovery(Day 90+/-7 days)
  • HD-sEMG signals associated with Muscle Mass Index(Day 7)
  • HD-sEMG signals associated with grip strength(Day 7)
  • HD-sEMG signals associated with physical performance(Day 7)
  • HD-sEMG signals associated with quadriceps muscle and subcutaneous fat thickness(Day 7)
  • Progress in muscle parameters(Day 21 +/-3 days)
  • Correlation between muscle parameters and in-hospital complications(Day 21 +/-3 days)
  • Correlation between muscle parameters and quality of life(Day 90+/-7 days)
  • HD-sEMG signals associated with functional recovery(Day 21 +/-3 days)
  • HD-sEMG signals associated with Muscle Mass Index(Day 1)
  • HD-sEMG signals associated with grip strength(Day 1)
  • HD-sEMG signals associated with physical performance(Day 1)
  • HD-sEMG signals associated with quadriceps muscle and subcutaneous fat thickness(Day 1)
  • Correlation between muscle parameters and quality of life(Day 1)
  • Correlation between muscle parameters and quality of life(Day 21 +/-3 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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