跳至主要内容
临床试验/NCT04842773
NCT04842773已完成不适用

MESSAge Study : Ultrasound Measurement of Sarcopenia in the Elder Subject

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年10月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Combinaison of US measurements

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

US measurement of sarcopenia

Experimental

干预措施: Ultrasound measurement (Diagnostic Test)

结局指标

主要结局

Combinaison of US measurements

时间窗: 1 day

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

次要结局

  • Inter-operator reproductibility(1 day)
  • Muscle elasticity(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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