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临床试验/NCT03591809
NCT03591809已完成不适用

The Effect of Combined Exercise Training on Cognitive Functions in Patients With Multiple Sclerosis

Gazi University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年9月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
cognitive function

研究概览

简要总结

It is stated that the affected cognitive functions in Multiple Sclerosis are learning, memory, attention, speed of information processing, visuospatial skills, and executive functions. The speed of information processing, visual learning and memory are the most frequently affected components in MS. For this reason, approaches to increase cognitive functions by activating neuroprotective mechanisms such as exercise in patients with MS are needed.

The purpose of this study is to examine the effect of combined exercise training on cognitive functions in patients with MS.

详细描述

The study was designed as a randomized, controlled, single-blind trial. This study will include patients with MS who 0-5.5 according to the Extended Disability Status Scale (EDSS) and between 18-65 years. The patient will be randomized into a combined training group and a control group. The patients in the control group will not apply an exercise training. The combined exercise training group will be given combined exercise training, consisting of Pilates and aerobic exercise, three times during 8 weeks. Both groups will be reevaluated 8 weeks after the initial assessment.

Statistical analyses will be performed using the SPSS software version 15 (SPSS Inc. Chicago, IL, USA). The pre-training and post-training measurements of groups will be compared with the Wilcoxon Test. The significance level was set at p< 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

To ensure blinding, the assessor physiotherapist will not be aware of the arm to which the subjects belong

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

  • Ambulatory
  • Stable phase of the disease without relapses in the last 3 month
  • EDSS between 2-5,5.

排除标准

  • Orthopedic, vision, hearing, or perception problems
  • Any cardiovascular or pulmonary disease in which exercise is contraindicated

研究组 & 干预措施

combined exercise training group

Experimental

The combined exercise training group will be given combined exercise training, consisting of Pilates and aerobic exercise, three times during 8 weeks.

干预措施: combined exercise training (Other)

Control group

No Intervention

The patients in the control group will not apply an exercise training.

结局指标

主要结局

cognitive function

时间窗: Thirty minutes]

The Brief Repeatable Battery of Neuropsychological Tests

次要结局

  • Multiple Sclerosis Quality of Life-54(ten minutes)
  • functional exercise capacity(ten minutes)
  • Fatigue(five minutes)

研究者

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

Cagla Ozkul

research assistant

Gazi University

研究点 (1)

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