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临床试验/NCT06603701
NCT06603701终止不适用

Follow up of Strength and Body Composition With Impedancemeter Device During the First 10 Days After Acute Stroke.

Centre Hospitalier Régional d'Orléans2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2024年6月28日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
2
主要终点
rate of sarcopenia

研究概览

简要总结

Regardless of the cause of immobilization, within days or weeks there is rapidly a decrease in strength and muscle mass, which can lead to sarcopenia. In severe strokes, immobilization and neurologic damage may be added to promote sarcopenia. Several studies in Asian populations confirm rapid increases in sarcopenia rates after stroke, but there are only rare data in Western populations. The aim of this work is to monitor during the first 10 days after a severe stroke leading to a reduction in ambulation, the evolution of muscle strength (studied in dynamometry), body composition (studied by impedance measurement) and sarcopenia rates. Investigators will also look for factors that predict the occurrence of this sarcopenia (such as sex, age, initial deficiency, stroke volume, swallowing disorders, etc.).

详细描述

In stroke patients, muscle damage combines many mechanisms such as immobilization, nutritional disorders , sympathetic activity, inflammation and denervation . These general factors explain that post-stroke sarcopenia is also observed on the side considered healthy .

Several meta-analyzes have been carried out on this subject . In the study by Inoue et al., which brings together 35 studies on the subject, the rates of sarcopenia observed were overall of the order of 15% before the stroke, of 30% in the 10 days post-stroke and of the order of 50% in the first semester . Only about 10 studies have been performed in the acute phase . However, the majority of these studies were performed in Asian populations (32 of them). But this is a population with demographic and physiological characteristics that are different from those in the West. Thus, body mass indices are lower and the representation of older people is higher in the population (the Japanese population is the oldest in the world).

Body composition may be a predictor of the course of recovery from stroke. In a cohort study it was thus shown by bioimpedance measurements that patients with the lowest muscle mass index had more severe neurological deficits at admission. They also had poorer functioning and longer hospital stays. Muscle mass is an independent variable in predicting what happens to people who have had a stroke.

Strokes cause motor deficits that reduce movement on the deficit side but also on the unaffected side. Sarcopenia (loss of strength and muscle mass) develops in the first few days after a stroke and worsens the consequences of neurologic damage. While immobilization rapidly leads to sarcopenia, sarcopenia has been poorly studied in acute stroke, especially in Asian populations, which are unrepresentative of Western populations.

The aims of this work are to:

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

  • Acute stroke patient
  • Over 18 years of age
  • Functional Ambulation Categories (FAC) < 3
  • NIHSS upper limb score ≥ 1
  • Able to understand assessment instructions
  • Non-objection to the study
  • Affiliated with a social security scheme

排除标准

  • Person under guardianship or curatorship.
  • Person deprived of liberty
  • Person under court protection
  • Other neurological or rheumatological pathology limiting mobility
  • Presence of a pacemaker or defibrillator.
  • Pregnant or breast-feeding woman

结局指标

主要结局

rate of sarcopenia

时间窗: Day 8

The rate of sarcopenia will be defined using the maximum flexion force of the fingers measured on a digital Jamar dynamometer in the healthy upper limb.

次要结局

  • total skeletal muscle mass and per limb segment(Day 8)
  • total angle phase and per limb segment(Day 8)
  • Muscular strength of the upper limb deficiency(Day 8)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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