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临床试验/NCT06051019
NCT06051019已完成不适用

Comparison Between the Effects on Fatigue of Aerobic Training Versus Balance Training in Patients With Multiple Sclerosis: a Randomised Crossover Trial.

Istituto Auxologico Italiano0 个研究点目标入组 39 人开始时间: 2016年2月17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
39
主要终点
Modified Fatigue Impact Scale Italian version

研究概览

简要总结

Fatigue and impaired balance frequently affect patients with Multiple Sclerosis (MS). This is an open, prospective randomised crossover trial aimed at clarifying whether an improvement in balance control after balance training would also improve fatigue in patients with MS. Balance training will be compared to aerobic training, which is known to be effective on fatigue.

详细描述

Fatigue is known to affect patients with Multiple Sclerosis (MS), with a prevalence ranging from 55% to 83%, thus contributing to the level of disability, compromising the Quality of Life, and increasing the overall treatment costs. For these reasons, fatigue is considered a main target for pharmacological and non-pharmacological therapies for MS.

The physiopathology of fatigue in MS is still not completely understood, and previous research has shown correlations with reduced motor performance, disease progression and depression. Some possible mechanisms of fatigue in MS have been hypothesised but not yet proven, such as structural alterations in the central nervous system, altered immune function in the brain, impaired pituitary gland function, and changes in cardiac or muscle activity.

Patients with MS also frequently show balance impairments, with prevalence peaking at 87.9%, and previous studies have suggested a causal relationship between fatigue and balance deficits.

Therapeutic exercise has shown a key role in contrasting the functional decline and disability secondary to MS. Several studies have evaluated the effects of different types of training, such as balance training and aerobic training, on balance impairment and the overall patient's functional performance.

In the literature, it is not uncommon to observe improvements in fatigue after the administration of exercise therapy targeted at the balance impairment. However, the literature has not yet clarified whether an improvement in balance control after balance training would also result in an improvement in the scales used to measure fatigue.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Modified Fatigue Impact Scale Italian version

时间窗: The Modified Fatigue Impact Scale was assessed: before intervention, at end of first intervention, 30 days after end of first intervention, before second intervention, at end of second intervention, 30 days after end of second intervention

Modified Fatigue Impact Scale (mFIS) Italian version: The Modified Fatigue Impact Scale is a self-administered questionnaire comprising 21 items assessing how often fatigue interferes with everyday life. Modified Fatigue Impact Scale score ranges from 0 to 84, with higher scores indicating more fatigue.

次要结局

  • Equiscale(The Equiscale was assessed: before intervention, at end of first intervention, 30 days after end of first intervention, before second intervention, at end of second intervention, 30 days after end of second intervention)
  • Equitest® Sensory Organization Test(The Sensory Organization Test was computed: before intervention, at end of first intervention, 30 days after end of first intervention, before second intervention, at end of second intervention, 30 days after end of second intervention)
  • Gait speed(The gait speed was assessed: before intervention, at end of first intervention, 30 days after end of first intervention, before second intervention, at end of second intervention, 30 days after end of second intervention)

研究者

申办方类型
Other
责任方
Sponsor

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