跳至主要内容
临床试验/NCT07011030
NCT07011030已完成不适用

Comparison of the Use of a Bioimpedance Meter With Integretaed Electrodes and Osteodensitometry for the Diagnosis os Sarcopenia in the Elderly

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年9月23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
72
试验地点
1
主要终点
Appendicular skeletal muscle mass

研究概览

简要总结

Sarcopenia is defined as the loss of muscle strength and mass associated with aging and is one of the main causes of frailty in older people, and therefore of their ability to age gracefully. Given the aging of the French population, the diagnosis and management of this condition is a major public health issue and, in this context, it is therefore necessary to be able to quickly assess people's skeletal muscle mass.

In its recommendations, French National Authority for Health recommends the use osteodensitometry and bioimpedance analysis (BIA) to assess skeletal muscle mass in the limbs for the purpose of diagnosing sarcopenia. Traditionally, BIA assessment is performed while lying down using adhesive electrodes placed on the hands and feet. The Biody XpertZM3 is a BIA device that allows seated measurement using integrated electrodes, enabling skeletal muscle mass to be assessed by bioimpedance analysis without the use of adhesive electrodes. However, the measurement position could alter the impedances measured and therefore the results obtained compared to other devices on the market as well as osteodensitometer

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Men or women aged 60 or over already receiving care at the Day Hospital of the Rehabilitation, Independence and Aging Center or the Frailty Platform of the Rehabilitation, Independence and Aging Center.
  • •Patients affiliated with or covered by a social security system.
  • •Patients who have signed an informed consent form in advance.

排除标准

  • •Vulnerable persons as defined in Articles L1121-5 to -8
  • •People with pacemakers, implantable defibrillators, or other electronic medical devices
  • •Musculoskeletal disorders that prevent bioimpedance measurement in a seated position
  • •Any condition of fluid retention or dehydration
  • •Absence of a measurement site (muscle resection or amputation)

研究组 & 干预措施

Skeletal muscle mass measurement

Experimental

Patients will undergo a:

  • Bioimpedance analysis with the Biody XpertZM 3 (bioimpedance device with integrated electrodes )
  • Osteodensitometer analysis with the SRATOS DR

干预措施: Measure of skeletal muscle mass (Other)

结局指标

主要结局

Appendicular skeletal muscle mass

时间窗: day 0

Comparison of skeletal muscle mass of the limbs (in kg) obtained by bioimpedance analysis using integrated electrodes and using osteodensitometry

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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