Ultrasound (US) Measurement of Sarcopenia in the Elder Subject (MESSAGE)

MESSAge Study : Ultrasound Measurement of Sarcopenia in the Elder Subject

Sarcopenia is a generalized, progressive and multifactorial muscle impairment, causing multiple pathologies and their consequences such as falls, fractures, dependence, worsening of cognitive disorders and death. Interventions to combat the progression of sarcopenia should be introduced as soon as clinically suspected, based on functional tests to measure muscle strength. Diagnostic confirmation of sarcopenia can be done using several validated methods of estimating muscle mass: magnetic resonance imaging (MRI), computed tomography (CT), biphotonic absorptiometry (DEXA) or bio-impedanceometry. Their availability in clinical routine remains limited due to their high costs and/or lack of accessibility depending on the place of practice. On the other hand, there are certain pitfalls for carrying out these various examinations, in connection with several common clinical problems in the study population: mobility disorders and neurodegenerative disorders disabling for transport and access to the examination table for imaging examinations, hydration disorders distorting measures for bio-impedancetry.

Previous studies suggest that ultrasound may be as effective a tool as previous methods for diagnostic confirmation of sarcopenia. Because of its non-invasive and non-irradiating nature, its affordability, its short duration of realization, its availability and its low constraints of realization, the ultrasound could help to remove some of the current limits to the diagnostic confirmation of sarcopenia.

The investigators hypothesis is that ultrasound can be used to implement a simple and reliable protocol for assessing sarcopenia in the elderly. It could also be used to detect sarcopenia at an early stage ("presarcopenia") while the decrease in muscle mass is not yet accompanied by a decrease in skeletal muscle strength.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Diagnostic test: Ultrasound measurement

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Provence Alpes Cote d'Azur
    • Nice, Provence Alpes Cote d'Azur, France, 06000
      • University Hospital of Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 75 or older
• SARC-F > 4
• Decrease in muscle strength: grip strength <27 kg for men and <16 kg for women; and/or Chair stand test < 15 seconds
• Patient affiliated or beneficiary of a social security plan
• Patient who has signed informed consent beforehand

Exclusion Criteria:

• Neurocognitive disorder preventing the expression of informed consent
• Lack of a measurement site (muscle resection or amputation)
• Impossibility or contraindication to strict dorsal and/or ventral decubitus
• Any associated neuromuscular pathology that may alter muscle composition and trophicity
• Wearing a pacemaker
• Any state of water inflation or dehydration
• History of surgery on the studied lower limb less than 6 months old
• Patients protected by law under guardianship or under curate, or unable to participate in a clinical study under Article L. 1121-16 of the French Code of Public Health

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: US measurement of sarcopenia	Diagnostic test: Ultrasound measurement; Ultrasound measurement of sarcopenia in an elderly population

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combinaison of US measurements	To determine the most relevant combination of ultrasound measurements, the investigators will assess the muscles thickness in centimeters.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-operator reproductibility	To assess inter-operator reproducibility	1 day
Muscle elasticity	To explore whether muscle elasticity is a relevant ultrasound measure for assessing sarcopenia in an elderly geriatric population. Muscles elasticity will be assessed in meter/seconde.	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 9, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 20-AOI-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No