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临床试验/NCT03983720
NCT03983720终止2 期

Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2020年1月21日最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
67
试验地点
1
主要终点
Voluntary maximum contraction

研究概览

简要总结

Chronic fatigue is the most common and debilitating symptom in multiple sclerosis patients. This chronic fatigue affects 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 this feeling of chronic fatigue. 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 will allow to optimize rehabilitation treatments to decrease the apparition/persistence of chronic fatigue and in fine improve quality of life.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For Patients:
  • Aged ≥ 18 and ≤ 70 years
  • Men or women
  • With multiple sclerosis since 2 and 25 years
  • Affiliates or beneficiaries of social security scheme
  • Signed consent
  • For Healthy volunteers:
  • Aged ≥ 18 and ≤ 70 years
  • Men or women
  • Matched in accordance with age, sex and level of physical activity

排除标准

  • For Patients and Healthy volunteers:
  • High heart rate resting
  • Blood pressure > 144/94 mmHg
  • Recent adjustment of drug or drug can have an impact on fatigue or stimulant for fatigue
  • Taking neuroactive substances that can alter corticospinal excitability
  • Contraindication at application magnetic field
  • Contraindication at Magnetic Resonance Imaging (MRI)
  • Currently participating in a structured exercise program
  • For Patients only:
  • Spasticity or cerebellar ataxia
  • Abnormal range of motion (toe and/or ankle)
  • Musculoskeletal injuries that impedes pedaling
  • Appearance of symptoms of multiple sclerosis in the 90 days preceding the study
  • For Healthy volunteers:
  • Neurological diseases, cardiovascular, musculoskeletal

结局指标

主要结局

Voluntary maximum contraction

时间窗: Day : 30

Comparison the percentage of decrease in voluntary maximum contraction reported after the fatiguing task. Measured by an instrumented measuring pedal (PowerForce pedal, Model PF1.0.0.0, Radlabor GmbH, Freiburg, Germany)

次要结局

  • VO2 max(Day : 30)
  • Anemia(Day : 30)
  • Thermoregulation(Day : 30)
  • Muscle oxygen extraction capacity(Day : 30)
  • Heart rate(Day : 30)
  • Neuromuscular function during the dynamic strenuous exercise(Day : 30)
  • Metabolic fatigue(Day : 30)
  • Inflammation(Day : 30)
  • Cognitive fatigue(Day : 30)
  • Sleep quality(Day : 30)
  • Perceived fatigue(Day : 30)
  • Muscle volume(Day : 30)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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