HD-sEMG Markers of Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 175
- 试验地点
- 12
- 主要终点
- Electromyographic signals of the rectus femoris collected by the HD-sEMG technique
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 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.
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 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.
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
- 是
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
- •Untreated/unbalanced endocrinological pathology
- •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
结局指标
主要结局
Electromyographic signals of the rectus femoris collected by the HD-sEMG technique
时间窗: 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).
次要结局
- Grip strength by dynamometer (kg)(day1-day7)
- Number of participants with falls. Definition of " fallers " : at least 1 fall in the last 12 months(day1- day7)
- Skeletal muscle mass index (SMMI in kg/m2, skeletal muscle mass/height2) collected by DEXA(day1-day7)
- SPPB score (SHORT PHYSICAL PERFORMANCE BATTERY score)(day1-day7)
- HD-sEMG muscle data, measured during lower limb quadriceps extension by High Definition Surface Electromyography HD-sEMG(1 month post inclusion)
- Muscle and subcutaneous fat thicknesses of the quadriceps in mm(day1-day7)
- Rate of Mortality at 1 month(1 month post inclusion)