Combined Exercise Training in Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: combined exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ambulatory Stable phase of the disease without relapses in the last 3 month EDSS between 2-5,5. Exclusion Criteria: Orthopedic, vision, hearing, or perception problems Any cardiovascular or pulmonary disease in which exercise is contraindicated

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled, single-blind trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combined exercise training group<br>The combined exercise training group will be given combined exercise training, consisting of Pilates and aerobic exercise, three times during 8 weeks. | Other: combined exercise training<br>* The combined exercise training group will be given combined exercise training, consisting of Pilates and aerobic exercise, three times during 8 weeks.<br>|
| No Intervention: Control group<br>The patients in the control group will not apply an exercise training. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive function | The Brief Repeatable Battery of Neuropsychological Tests | Thirty minutes] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional exercise capacity | The Six-Minute Walking Test (6MWT) was performed to determine functional exercise capacity | ten minutes | 
| Fatigue | Fatigue impact scale will be used to asses fatigue. There are 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a continuous scale of 0-160. It is composed of three subscales that describe how fatigue impacts upon cognitive (10 items), physical (10 items) and psychosocial functioning (10 items). Cognitive functioning concerns concentration, memory, thinking and organization of thoughts. Physical functioning reflects motivation, effort, stamina and coordination. Psychosocial functioning describes the impact of fatigue upon isolation, emotions, workload and coping.A higher score indicates a higher fatigue impact. | five minutes | 
| Multiple Sclerosis Quality of Life-54 | The questionnaire consists of 54 questions with 12 sub-sections; physical function, health perceptions, energy/fatigue, role limitations-physical, pain, sexual function, social function, health distress, the overall quality of life, emotional well-being, role limitations-emotional, cognitive function. The summary scores are the physical health composite summary and the mental health composite summary. There is no single overall score for the MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores. In this scale, the scoring of each question is different from each other and a higher score indicates a lower quality of life. | ten minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive function, fatigue, quality of life, Functional exercise capacity