High-definition Surface Electromyography Markers for the Diagnosis of Sarcopenia (CHRONOS-SARC)
Primary Purpose
Sarcopenia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HD-sEMG
- Quadriceps muscle ultrasound
IPAQ Physical Activity Questionnaire.
Sponsored by
About this trial
This is an interventional diagnostic trial for Sarcopenia focused on measuring High definition surface electromyography, Sarcopenia, Muscle, Biphotonic X-ray absorptiometry, Dual x-ray absorptiometry (DEXA)
Eligibility Criteria
Inclusion Criteria:
- Patient aged 75 to 95 years
- Score ≥4 on the SARC-F screening questionnaire
- Enrolled in a social security plan (no AME)
- Informed and consenting patient
Exclusion Criteria:
- BMI <18.5 or ≥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
- Fracture or trauma during the previous 6 months
- Bilateral hip prosthesis
- Skin problem that may interfere with the recording of surface EMG activity
- Patient under guardianship / curatorship
Sites / Locations
- Service de soins de suite et de réadaptation Gériatrique 1Recruiting
- Service de gériatrie aigue polyvalente (GAP)Recruiting
- Service de soins de suite et de réadaptation gériatrique 2Recruiting
- Unité d'Explorations fonctionnelles du sujet âgé, Hôpital Charles Foix
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Elderly patients suspected of sarcopenia
Arm Description
Outcomes
Primary Outcome Measures
Electromyographic signals of the rectus femoris collected by the HD-sEMG technique
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
Number of participants with falls. Definition of " fallers " : at least 1 fall in the last 12 months
Information will be collected in the medical record.
Skeletal muscle mass index (SMMI in kg/m2, skeletal muscle mass/height2) collected by DEXA
Grip strength by dynamometer (kg)
SPPB score (SHORT PHYSICAL PERFORMANCE BATTERY score)
Short Physical Performance Battery (SPPB): score range 0-12, higher score means a better outcome
HD-sEMG muscle data, measured during lower limb quadriceps extension by High Definition Surface Electromyography HD-sEMG
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.
Rate of Mortality at 1 month
Rate of participants who deceased at 1 month. Mortality will be measured with vital status at 1 month.
Muscle and subcutaneous fat thicknesses of the quadriceps in mm
Muscle and subcutaneous fat thickness of the quadriceps in mm evaluated by ultrasound
Full Information
NCT ID
NCT04987814
First Posted
April 29, 2021
Last Updated
December 7, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04987814
Brief Title
High-definition Surface Electromyography Markers for the Diagnosis of Sarcopenia
Acronym
CHRONOS-SARC
Official Title
HD-sEMG Markers of Sarcopenia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
May 18, 2023 (Anticipated)
Study Completion Date
May 18, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 75-95 years hospitalized in the acute geriatric ward and suspected of sarcopenia (Score ≥4 on the SARC-F screening questionnaire).
The inclusion duration will be 12 months and adding a 1-month patient follow-up as part of routine care, the total study duration will be 13 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
High definition surface electromyography, Sarcopenia, Muscle, Biphotonic X-ray absorptiometry, Dual x-ray absorptiometry (DEXA)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Elderly patients suspected of sarcopenia
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
HD-sEMG
Intervention Description
high definition surface electromyography, allowing the recording of muscle activation signals sensitive to the intensity of the contraction and indirectly to the muscle strength as well as to the muscular fatigability, but also capable of measuring the modifications of the recruitment modalities of the motor units. This recording will be made on the rectus femoris during knee extension, either in the lying position or during chair lifts, depending on the patient's functional state.
Intervention Type
Other
Intervention Name(s)
- Quadriceps muscle ultrasound
Intervention Description
Muscle Ultrasound with Philips Lumify Wireless Handheld Ultrasound for Android - Model - L12-4 linear probe, allowing performance at the patient's bed.
Intervention Type
Other
Intervention Name(s)
IPAQ Physical Activity Questionnaire.
Intervention Description
physical activity assessment questionnaire/adapted version for seniors
Primary Outcome Measure Information:
Title
Electromyographic signals of the rectus femoris collected by the HD-sEMG technique
Description
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).
Time Frame
day1-day7
Secondary Outcome Measure Information:
Title
Number of participants with falls. Definition of " fallers " : at least 1 fall in the last 12 months
Description
Information will be collected in the medical record.
Time Frame
day1- day7
Title
Skeletal muscle mass index (SMMI in kg/m2, skeletal muscle mass/height2) collected by DEXA
Time Frame
day1-day7
Title
Grip strength by dynamometer (kg)
Time Frame
day1-day7
Title
SPPB score (SHORT PHYSICAL PERFORMANCE BATTERY score)
Description
Short Physical Performance Battery (SPPB): score range 0-12, higher score means a better outcome
Time Frame
day1-day7
Title
HD-sEMG muscle data, measured during lower limb quadriceps extension by High Definition Surface Electromyography HD-sEMG
Description
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.
Time Frame
1 month post inclusion
Title
Rate of Mortality at 1 month
Description
Rate of participants who deceased at 1 month. Mortality will be measured with vital status at 1 month.
Time Frame
1 month post inclusion
Title
Muscle and subcutaneous fat thicknesses of the quadriceps in mm
Description
Muscle and subcutaneous fat thickness of the quadriceps in mm evaluated by ultrasound
Time Frame
day1-day7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient aged 75 to 95 years
Score ≥4 on the SARC-F screening questionnaire
Enrolled in a social security plan (no AME)
Informed and consenting patient
Exclusion Criteria:
BMI <18.5 or ≥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
Fracture or trauma in lower limbs during the previous 6 months
Bilateral hip prosthesis
Skin problem that may interfere with the recording of surface EMG activity
Patient under guardianship / curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kiyoka KINUGAWA, MD PhD
Phone
+331 49 59 47 53
Email
kiyoka.kinugawa@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sofiane BOUDAOUD, Pr
Phone
+(33) 03 44 23 79 29
Email
sofiane.boudaoud@utc.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiyoka KINUGAWA, MD PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de soins de suite et de réadaptation Gériatrique 1
City
Ivry sur Seine
ZIP/Postal Code
94205
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony MEZIERE, MD
Email
anthony.meziere@aphp.fr
Facility Name
Service de gériatrie aigue polyvalente (GAP)
City
Ivry-sur-Seine
ZIP/Postal Code
94205
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Monti, Md
Email
alexandra.monti@aphp.fr
Facility Name
Service de soins de suite et de réadaptation gériatrique 2
City
Ivry-sur-Seine
ZIP/Postal Code
94205
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adeline GOURONNEC, MD
Email
adeline.gouronnec@aphp.fr
Facility Name
Unité d'Explorations fonctionnelles du sujet âgé, Hôpital Charles Foix
City
Ivry-sur-Seine
ZIP/Postal Code
94205
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiyoka KINUGAWA, MD PhD
Phone
+33 1 49594750
Email
kiyoka.kinugawa@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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High-definition Surface Electromyography Markers for the Diagnosis of Sarcopenia
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