Combined Exercise Training in Patients With Multiple Sclerosis

NCT ID: NCT03591809

Last Updated: 2019-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2019-10-21

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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled, single-blind trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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combined exercise training group

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

Group Type EXPERIMENTAL

combined exercise training

Intervention Type OTHER

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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combined exercise training

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Cagla Ozkul

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cagla Ozkul

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

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Gazi University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Rao SM, Leo GJ, Bernardin L, Unverzagt F. Cognitive dysfunction in multiple sclerosis. I. Frequency, patterns, and prediction. Neurology. 1991 May;41(5):685-91. doi: 10.1212/wnl.41.5.685.

Reference Type BACKGROUND
PMID: 2027484 (View on PubMed)

Rogers JM, Panegyres PK. Cognitive impairment in multiple sclerosis: evidence-based analysis and recommendations. J Clin Neurosci. 2007 Oct;14(10):919-27. doi: 10.1016/j.jocn.2007.02.006. Epub 2007 Jul 30.

Reference Type BACKGROUND
PMID: 17659875 (View on PubMed)

Janculjak D, Mubrin Z, Brinar V, Spilich G. Changes of attention and memory in a group of patients with multiple sclerosis. Clin Neurol Neurosurg. 2002 Jul;104(3):221-7. doi: 10.1016/s0303-8467(02)00042-2. No abstract available.

Reference Type BACKGROUND
PMID: 12127658 (View on PubMed)

Rosti-Otajarvi EM, Hamalainen PI. Neuropsychological rehabilitation for multiple sclerosis. Cochrane Database Syst Rev. 2014 Feb 11;2014(2):CD009131. doi: 10.1002/14651858.CD009131.pub3.

Reference Type BACKGROUND
PMID: 24515630 (View on PubMed)

Cotman CW, Berchtold NC, Christie LA. Exercise builds brain health: key roles of growth factor cascades and inflammation. Trends Neurosci. 2007 Sep;30(9):464-72. doi: 10.1016/j.tins.2007.06.011. Epub 2007 Aug 31.

Reference Type BACKGROUND
PMID: 17765329 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20223924 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26157723 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15765197 (View on PubMed)

Other Identifiers

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400

Identifier Type: -

Identifier Source: org_study_id

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