High-definition Surface Electromyography Markers for the Diagnosis of Sarcopenia

NCT04987814 | Recruiting

• 1 other identifier: APHP201339
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 6

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.

Conditions

Sarcopenia

Keywords

High definition surface electromyography; Sarcopenia; Muscle; Biphotonic X-ray absorptiometry; Dual x-ray absorptiometry (DEXA)

Outcome Measures

Primary Outcomes (1)

• 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).

  day1-day7

Secondary Outcomes (7)

• 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

• Grip strength by dynamometer (kg)

  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

Study Arms (1)

Elderly patients suspected of sarcopenia

EXPERIMENTAL

Other: HD-sEMG; Other: - Quadriceps muscle ultrasound; Other: IPAQ Physical Activity Questionnaire.

Interventions

HD-sEMG OTHER

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.

Elderly patients suspected of sarcopenia

- Quadriceps muscle ultrasound OTHER

Muscle Ultrasound with Philips Lumify Wireless Handheld Ultrasound for Android - Model - L12-4 linear probe, allowing performance at the patient's bed.

Elderly patients suspected of sarcopenia

IPAQ Physical Activity Questionnaire. OTHER

physical activity assessment questionnaire/adapted version for seniors

Elderly patients suspected of sarcopenia

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (6)

Service de gériatrie aigue polyvalente (GAP)

Ivry-sur-Seine, 94205, France

RECRUITING

Service de soins de suite et de réadaptation Gériatrique 1

Ivry-sur-Seine, 94205, France

RECRUITING

Service de soins de suite et de réadaptation gériatrique 2

Ivry-sur-Seine, 94205, France

RECRUITING

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

Ivry-sur-Seine, 94205, France

NOT YET RECRUITING

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

Paris, 75012, France

RECRUITING

Service de soins de suite et de réadaptation Gériatrique Hôpital Rothschild

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Kiyoka KINUGAWA, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiyoka KINUGAWA, MD PhD

CONTACT

+331 49 59 47 53; kiyoka.kinugawa@aphp.fr

Sofiane BOUDAOUD, Pr

CONTACT

+(33) 03 44 23 79 29; sofiane.boudaoud@utc.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: August 3, 2021
• Study Start: May 18, 2022
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): December 18, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

FR (6)