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临床试验/NCT04933097
NCT04933097已完成不适用

Evaluation of a New Screening Method for Sarcopenia in Rheumatoid Arthritis

CHU de Reims2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2021年7月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
164
试验地点
2
主要终点
Quadricepsmeasurement

研究概览

简要总结

Evaluation of a new screening method for sarcopenia in rheumatoid arthritis

详细描述

Rheumatoid arthritis (RA) is the most common inflammatory rheumatic disease, affecting 0.4-0.8% of the population. This inflammatory rheumatism leads to progressive, bilateral and symmetrical joint destruction, predominantly in the hands, which is responsible for significant functional repercussions, a sedentary lifestyle and a reduction in physical capacities leading to the onset of comorbidities. Among these comorbidities, sarcopenia is an emerging concept.

Sarcopenia is defined as a decrease in the quality and quantity of a person's muscles. It can be primary, and therefore due to physiological ageing, or secondary to a chronic disease such as inflammatory rheumatism. The definition of sarcopenia has become consensual since the 2019 European Working group on Sarcopenia in Older People (EWGSOP) recommendations and is characterised by:

  • A decrease in strength. It is assessed by the grip test with a threshold of 27 kg in men and 16 kg in women. When this manual grip measurement is not possible, the authors advise measurement on an isokinetic device.
  • a decrease in overall muscle mass. This is assessed either by dual energy X-ray absorptiometry (DEXA whole body, the reference technique) and defined by a decrease in the appendicular muscle mass index (AMMI) < 7 kg/m² in men and < 5.5 kg/m² in women (AMMI corresponds to the lean mass of the 4 limbs in relation to the height for Europeans); or on the scanographic measurement of the surface of the psoas muscle at L3.
  • a decrease in muscular performance. This last point makes it possible to evaluate the severity of this sarcopenia. Muscular performance is assessed by walking speed and/or tests combining balance and walking such as the short physical performance battery test (SPPB) or the timed up and go (TUG).

The diagnosis of sarcopenia is certain when there is a decrease in muscle mass; it is characterised as severe when there is a decrease in physical performance.

Two other concepts are associated:

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

入选标准

  • Rheumatoid arthritis defined according to ACR/EULAR 2010 criteria,
  • Follow-up at the University Hospital of Reims,
  • Signed consent

排除标准

  • Inability to perform a functional test (walking test)
  • Patient under legal protection
  • Patients not affiliated to the social security system
  • Pregnant women

结局指标

主要结局

Quadricepsmeasurement

时间窗: Day 0

The three measurements will be performed by two different operators and the results will be expressed in Newton/m.

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (2)

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