Combined Exercise Training in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03591809
• Other study ID #: 400
• Status: Completed
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: October 21, 2019

Study information

• Verified date: October 2019
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 21, 2019
• Est. primary completion date: October 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. Epub 2007 Aug 31. Review. Erratum in: Trends Neurosci. 2007 Oct;30(10):489. — View Citation

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. — View Citation

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. — View Citation

Rogers JM, Panegyres PK. Cognitive impairment in multiple sclerosis: evidence-based analysis and recommendations. J Clin Neurosci. 2007 Oct;14(10):919-27. Epub 2007 Jul 30. Review. — View 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. Epub 2005 Mar 16. — View Citation

Rosti-Otajärvi EM, Hämäläinen PI. Neuropsychological rehabilitation for multiple sclerosis. Cochrane Database Syst Rev. 2014 Feb 11;(2):CD009131. doi: 10.1002/14651858.CD009131.pub3. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive function	The Brief Repeatable Battery of Neuropsychological Tests	Thirty minutes]
Secondary	functional exercise capacity	The Six-Minute Walking Test (6MWT) was performed to determine functional exercise capacity	ten minutes
Secondary	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
Secondary	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