Combined Exercise Training in Patients With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
combined exercise training
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring cognitive function, fatigue, quality of life, Functional exercise capacity
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
Sites / Locations
- Gazi University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
combined exercise training group
Control group
Arm Description
The combined exercise training group will be given combined exercise training, consisting of Pilates and aerobic exercise, three times during 8 weeks.
The patients in the control group will not apply an exercise training.
Outcomes
Primary Outcome Measures
cognitive function
The Brief Repeatable Battery of Neuropsychological Tests
Secondary Outcome Measures
functional exercise capacity
The Six-Minute Walking Test (6MWT) was performed to determine functional exercise capacity
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03591809
Brief Title
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
October 18, 2019 (Actual)
Study Completion Date
October 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
cognitive function, fatigue, quality of life, Functional exercise capacity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled, single-blind trial
Masking
Outcomes Assessor
Masking Description
To ensure blinding, the assessor physiotherapist will not be aware of the arm to which the subjects belong
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
combined exercise training group
Arm Type
Experimental
Arm Description
The combined exercise training group will be given combined exercise training, consisting of Pilates and aerobic exercise, three times during 8 weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients in the control group will not apply an exercise training.
Intervention Type
Other
Intervention Name(s)
combined exercise training
Intervention Description
The combined exercise training group will be given combined exercise training, consisting of Pilates and aerobic exercise, three times during 8 weeks.
Primary Outcome Measure Information:
Title
cognitive function
Description
The Brief Repeatable Battery of Neuropsychological Tests
Time Frame
Thirty minutes]
Secondary Outcome Measure Information:
Title
functional exercise capacity
Description
The Six-Minute Walking Test (6MWT) was performed to determine functional exercise capacity
Time Frame
ten minutes
Title
Fatigue
Description
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.
Time Frame
five minutes
Title
Multiple Sclerosis Quality of Life-54
Description
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.
Time Frame
ten minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cagla Ozkul
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
2027484
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. doi: 10.1212/wnl.41.5.685.
Results Reference
background
PubMed Identifier
17659875
Citation
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.
Results Reference
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PubMed Identifier
12127658
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. doi: 10.1016/s0303-8467(02)00042-2. No abstract available.
Results Reference
background
PubMed Identifier
24515630
Citation
Rosti-Otajarvi EM, Hamalainen PI. Neuropsychological rehabilitation for multiple sclerosis. Cochrane Database Syst Rev. 2014 Feb 11;(2):CD009131. doi: 10.1002/14651858.CD009131.pub3.
Results Reference
background
PubMed Identifier
17765329
Citation
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. Erratum In: Trends Neurosci. 2007 Oct;30(10):489.
Results Reference
background
PubMed Identifier
20223924
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.
Results Reference
background
PubMed Identifier
26157723
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.
Results Reference
background
PubMed Identifier
15765197
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.
Results Reference
background
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Combined Exercise Training in Patients With Multiple Sclerosis
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