跳至主要内容
临床试验/NCT04363606
NCT04363606终止不适用

Chronic Fatigue Etiology and Recovery in Covid-19 Patients : the Role of Fatigability and Stay in Intensive Care

Centre Hospitalier Universitaire de Saint Etienne8 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2020年5月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
69
试验地点
8
主要终点
voluntary maximum force reduction

研究概览

简要总结

Chronic fatigue is the most common and debilitating symptom in intensive care unit (ICU) survivors. Indeed, it has been widely reported that patients who stayed in ICU for prolonged periods report a feeling of tiredness for months to years after ICU discharge. This symptom seems particularly pronounced in Covid-19 patients and may affect their quality of life by decreasing their capacity to perform simple tasks of daily life.

The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in the feeling of fatigue of Covid-19 patients. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology and its recovery will allow to optimize rehabilitation treatments to shorten the persistence of chronic fatigue and in fine improve life quality.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
35 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Taking neuroactive substances that can alter corticospinal excitability
  • Patients with co-morbidities leading to significant fatigue: e.g. cancerous pathologies, sleep apnea
  • Patients with neurodegenerative or neuromuscular disease
  • Contraindication to the application of a magnetic field
  • Contraindication to the practice of Magnetic Resonance Imaging
  • Participant is pregnant
  • Patients with psychiatric disorders
  • Paraplegic and hemiplegic patients
  • Addictive disorders

研究组 & 干预措施

"Non-fatigued" patients who have been in intensive care units

Experimental

干预措施: food diary (Other)

"Fatigued" patients who have been in intensive care units

Experimental

干预措施: Questionnaires (Other)

"Non-fatigued" patients who have been in intensive care units

Experimental

干预措施: Questionnaires (Other)

"Non-fatigued" patients who have been in intensive care units

Experimental

干预措施: blood test (Biological)

"Non-fatigued" patients who have been in intensive care units

Experimental

干预措施: Maximal effort test (Other)

"Non-fatigued" patients who have been in intensive care units

Experimental

干预措施: actigraphy (Device)

"Non-fatigued" patients who have been in intensive care units

Experimental

干预措施: Neuromuscular evaluation (Device)

"Non-fatigued" patients who have been in intensive care units

Experimental

干预措施: stool analysis (Other)

"Fatigued" patients who have been in intensive care units

Experimental

干预措施: blood test (Biological)

"Fatigued" patients who have been in intensive care units

Experimental

干预措施: Maximal effort test (Other)

"Fatigued" patients who have been in intensive care units

Experimental

干预措施: actigraphy (Device)

"Fatigued" patients who have been in intensive care units

Experimental

干预措施: Neuromuscular evaluation (Device)

"Fatigued" patients who have been in intensive care units

Experimental

干预措施: stool analysis (Other)

"Fatigued" patients who have been in intensive care units

Experimental

干预措施: food diary (Other)

patients who have not been in intensive care units

Experimental

干预措施: Questionnaires (Other)

patients who have not been in intensive care units

Experimental

干预措施: blood test (Biological)

patients who have not been in intensive care units

Experimental

干预措施: Maximal effort test (Other)

patients who have not been in intensive care units

Experimental

干预措施: actigraphy (Device)

patients who have not been in intensive care units

Experimental

干预措施: Neuromuscular evaluation (Device)

patients who have not been in intensive care units

Experimental

干预措施: stool analysis (Other)

patients who have not been in intensive care units

Experimental

干预措施: food diary (Other)

结局指标

主要结局

voluntary maximum force reduction

时间窗: 6 weeks post-discharge

次要结局

  • Neuromuscular function : cortical activity(6 weeks post-discharge)
  • Neuromuscular function : Peripheral function(6 weeks post-discharge)
  • Maximal oxygen uptake (VO2max)(6 weeks post-discharge)
  • metabolic fatigue(6 weeks post-discharge)
  • quality of sleep(6 weeks post-discharge)
  • muscle volume(6 weeks post-discharge)
  • microbiote intestinal(baseline and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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