Clinical trial NCT03591809: Combined Exercise Training in Patients With Multiple Sclerosis
Official title: The Effect of Combined Exercise Training on Cognitive Functions in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: cognitive function
fatigue
quality of life
Functional exercise capacity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, single-blind trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: cognitive function
timeFrame: Thirty minutes]
Secondary outcomes:
measure: functional exercise capacity
timeFrame: ten minutes
measure: Fatigue
timeFrame: five minutes
measure: Multiple Sclerosis Quality of Life-54
timeFrame: ten minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Cagla Ozkul
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Smith PJ, Blumenthal JA, Hoffman BM, Cooper H, Strauman TA, Welsh-Bohmer K, Browndyke JN, Sherwood A. Aerobic exercise and neurocognitive performance: a meta-analytic review of randomized controlled trials. Psychosom Med. 2010 Apr;72(3):239-52. doi: 10.1097/PSY.0b013e3181d14633. Epub 2010 Mar 11.
citation: Sangelaji B, Estebsari F, Nabavi SM, Jamshidi E, Morsali D, Dastoorpoor M. The effect of exercise therapy on cognitive functions in multiple sclerosis patients: A pilot study. Med J Islam Repub Iran. 2015 Apr 22;29:205. eCollection 2015.
citation: Romberg A, Virtanen A, Ruutiainen J. Long-term exercise improves functional impairment but not quality of life in multiple sclerosis. J Neurol. 2005 Jul;252(7):839-45. doi: 10.1007/s00415-005-0759-2. Epub 2005 Mar 16.