Ultrasound (US) Measurement of Sarcopenia in the Elder Subject

Sarcopenia Clinical Trial

— MESSAGE  

Official title:

MESSAge Study : Ultrasound Measurement of Sarcopenia in the Elder Subject

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04842773
• Other study ID #: 20-AOI-09
• Status: Completed
• Phase: N/A
• Start date: October 26, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Diagnostic Test:
• Ultrasound measurement
Ultrasound measurement of sarcopenia in an elderly population

Locations

Country	Name	City	State
France	University Hospital of Nice	Nice	Provence Alpes Cote d'Azur

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Inter-operator reproductibility	To assess inter-operator reproducibility	1 day
Secondary	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