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临床试验/NCT03255460
NCT03255460已完成不适用

Investigation of the Relationship Between Fatigue and Physical Activity Level in Patients With Multiple Sclerosis

Gazi University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Fatigue

研究概览

简要总结

Multiple sclerosis (MS) is a chronic, progressive and unpredictable disease of the central nervous system. In MS, various loss of strength, balance and gait disturbances arise in the central nervous system due to sensory and/or motor neuron degeneration. These disorders lead to limitations in individual activities and participation.

Fatigue is as reported one of the most common first three symptoms among patients with MS and affects up to 80% of the patients. Fatigue is defined as the lack of physical and/or mental energy. Sometimes fatigue can reduce the quality of life by leaving other disorders behind. The most important effect of fatigue is that individuals reduce their physical activity levels. This can lead to the inactivity-related secondary problems being added to the findings of the disease. So the physical capacities of individuals may gradually decrease.

In the literature, there are many studies showing that the level of physical activity of individuals with MS is lower than in healthy individuals. When the investigators analyze the studies that investigate the relation between fatigue and physical activity levels, it is seen that there is the single study about this subject in the literature.

As a result, additional studies are needed to investigate the level of physical activity and the factors affecting it in individuals with MS. Therefore, the investigators planned this study to investigate the relationship between fatigue and physical activity levels in patients with MS.

详细描述

According to sample size calculation 37 diagnosed Multiple Sclerosis patients and 37 healthy individuals will be included.The demographic characteristics of the participants initially will be taken and Expanded Disability Status Scale score of those of MS will be recorded. Then, fatigue severity and perception, physical activity level, balance, peripheral muscle strength, functional mobility, functional exercise capacity will be evaluated. Primary outcomes are fatigue and physical activity level; secondary outcomes are balance, peripheral muscle strength, functional mobility, functional exercise capacity.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years of age
  • Having a diagnosis of "Multiple Sclerosis" by a specialist physician
  • Relapse free in the last 3 mounts
  • Having an ambulatory status (Expanded Disability Status Scale score ≤ 6 )
  • No diagnosis of depression

排除标准

  • Any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research

结局指标

主要结局

Fatigue

时间窗: Eight minutes

Fatigue Impact Scale

Fatigue severity

时间窗: Five minutes

Fatigue Severity Scale

Physical activity behavior

时间窗: Three days

Evaluated using an ActiGraph (GT3X+)

Physical activity

时间窗: Five minutes

International Physical Activity Questionnaire

次要结局

  • Balance(Fifteen minutes)
  • Functional Mobility(Two minutes)
  • Muscle strength(Fifteen minutes)
  • Functional exercise capacity(Fifteen minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kader Eldemir

Research Asisstant

Gazi University

研究点 (1)

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