High-definition Surface Electromyography Markers for the Diagnosis of Sarcopenia
- Conditions
- Sarcopenia
- Interventions
- Other: HD-sEMGOther: - Quadriceps muscle ultrasoundOther: IPAQ Physical Activity Questionnaire.
- Registration Number
- NCT04987814
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 175
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Elderly patients suspected of sarcopenia IPAQ Physical Activity Questionnaire. - Elderly patients suspected of sarcopenia - Quadriceps muscle ultrasound - Elderly patients suspected of sarcopenia HD-sEMG -
- Primary Outcome Measures
Name Time Method Electromyographic signals of the rectus femoris collected by the HD-sEMG technique 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).
- Secondary Outcome Measures
Name Time Method 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 Information will be collected in the medical record.
Skeletal muscle mass index (SMMI in kg/m2, skeletal muscle mass/height2) collected by DEXA day1-day7 HD-sEMG muscle data, measured during lower limb quadriceps extension by High Definition Surface Electromyography HD-sEMG 1 month post inclusion HD-sEMG parameters will be collected by HD-sEMG technique with TMSi's Mobita equipment, CE marked (European compliance). They will be collected by electrical measurements from a grid of electrodes (32 channels) placed on the muscle surface. The results of the measurement will be represented by a muscle activation mapping.
Muscle and subcutaneous fat thicknesses of the quadriceps in mm day1-day7 Muscle and subcutaneous fat thickness of the quadriceps in mm evaluated by ultrasound
SPPB score (SHORT PHYSICAL PERFORMANCE BATTERY score) day1-day7 Short Physical Performance Battery (SPPB): score range 0-12, higher score means a better outcome
Rate of Mortality at 1 month 1 month post inclusion Rate of participants who deceased at 1 month. Mortality will be measured with vital status at 1 month.
Trial Locations
- Locations (6)
Service de soins de suite et de réadaptation Gériatrique 1
🇫🇷Ivry sur Seine, France
Service de gériatrie aigue polyvalente (GAP)
🇫🇷Ivry-sur-Seine, France
Service de soins de suite et de réadaptation -Plaies et cicatrisation
🇫🇷Paris, France
Service de soins de suite et de réadaptation Gériatrique Hôpital Rothschild
🇫🇷Paris, France
Service de soins de suite et de réadaptation gériatrique 2
🇫🇷Ivry-sur-Seine, France
Unité d'Explorations fonctionnelles du sujet âgé, Hôpital Charles Foix
🇫🇷Ivry-sur-Seine, France