Skip to main content
OpenTrials
Completed

NCT Number: NCT04842773

Ultrasound (US) 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Nice

Nice, Provence-Alpes-Côte d'Azur Region, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound measurement

Diagnostic Test

Ultrasound measurement of sarcopenia in an elderly population

Primary outcomes

  1. Combinaison of US measurements

    Time frame: 1 day

    To determine the most relevant combination of ultrasound measurements, the investigators will assess the muscles thickness in centimeters.

Secondary outcomes

  1. Inter-operator reproductibility

    Time frame: 1 day

    To assess inter-operator reproducibility

  2. Muscle elasticity

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

MESSAge Study : Ultrasound Measurement of Sarcopenia in the Elder Subject

Acronym: MESSAGE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 13, 2021
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.