跳至主要内容
临床试验/NCT05869487
NCT05869487招募中不适用

Evaluation of a Diagnostic Method: Calf Circumference Versus X-ray Absorptiometry in the Diagnosis of Sarcopenia in Elderly Hospitalized Participants

Centre Hospitalier Régional d'Orléans2 个研究点 分布在 1 个国家目标入组 298 人开始时间: 2023年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
298
试验地点
2
主要终点
Measurement of muscle mass using X-ray absorptiometry

研究概览

简要总结

This is a prospective single-center study to evaluate a diagnostic method. The main objective of the study is to evaluate the performance of calf circumference as a diagnostic method for sarcopenia in hospitalized elderly people, compared to a gold standard method which is X-ray absorptiometry. The study population are hospitalizing participants aged 75 years and older with an indication to search for sarcopenia.

详细描述

Sarcopenia is a loss of muscle mass associated with a loss of muscle strength. Sarcopenia is associated with an increase of mortality, risk of falling and hospitalization. The gold standard for assessing loss of muscle mass is X-ray absorptiometry. However, this exam is not systematically performed. The calf circumference (cutoff less than 31 centimeters) is preferentially used. However, this cutoff was defined from a population of women with a mean age of 80 years and a unfrail phenotypic profile that does not allow this result to be applied to elderly hospitalized patients.

The main objective of this study is to evaluate the performance of calf circumference as a diagnostic method for sarcopenia in hospitalized elderly people, compared to a gold standard method which is X-ray absorptiometry.

This is a single-center prospective study to evaluate a diagnostic method. The participants in the study will be hospitalized patients aged 75 years and over, with an indication to search for sarcopenia in the context of screening for protein-energy undernutrition under the recommendations of the French National Authority for Health. Participants will be included after being informed about the protocol and after obtaining their free and informed oral consent. Measurement of calf circumference will be performed before absorptiometry, the results of which will be analyzed in a blinded. The number of subjects to be included with a expected prevalence of 75%, specificity of 95% and an accuracy of 2% is 298 participants according to the literature. A sensitivity and specificity analysis will be performed using the ROC curve. A linear regression analysis will be performed with a significance threshold for the alpha risk of 5%.

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

入选标准

  • Age greater than or equal to 75 years
  • Hospitalization in a medical department or in the follow-up care or rehabilitation department of the Hospital Center of Orléans
  • Presence of an etiological criterion of undernutrition
  • Presence of a decrease in muscle strength

排除标准

  • Presence of one of two phenotypic criteria for undernutrition other than sarcopenia, which are body mass index less than 22 kilogram per square meter and weight loss (≥ 5 percent over 1 month or ≥ 10 percent over 6 months or ≥10 percent compared with usual weight before the disease).
  • Refusal to participate in the study
  • Patient under legal protection
  • Impossible to perform X-ray absorptiometry (behavioral problems, functional constraints to climb on the DXA machine)
  • Person not affiliated to a social security system

结局指标

主要结局

Measurement of muscle mass using X-ray absorptiometry

时间窗: Day 2

Measurement of appendicular mass by X-ray absorptiometry in kilograms

Measurement of muscle mass using calf circumference

时间窗: Day 2

Measurement with a tape measure (in centimetres) of the maximum circumference of the calf

次要结局

  • Circumference of the thigh(Day 0)
  • Arm circumference(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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