NCT03591809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 3, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

July 9, 2018

Last Update Submit

October 21, 2019

Conditions

Keywords

cognitive functionfatiguequality of lifeFunctional exercise capacity

Outcome Measures

Primary Outcomes (1)

  • cognitive function

    The Brief Repeatable Battery of Neuropsychological Tests

    Thirty minutes]

Secondary Outcomes (3)

  • functional exercise capacity

    ten minutes

  • Fatigue

    five minutes

  • Multiple Sclerosis Quality of Life-54

    ten minutes

Study Arms (2)

combined exercise training group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

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

combined exercise training group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ambulatory
  • Stable phase of the disease without relapses in the last 3 month
  • EDSS between 2-5,5.

You may not qualify if:

  • Orthopedic, vision, hearing, or perception problems
  • Any cardiovascular or pulmonary disease in which exercise is contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 2027484BACKGROUND
  • 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.

    PMID: 17659875BACKGROUND
  • 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.

    PMID: 12127658BACKGROUND
  • 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.

    PMID: 24515630BACKGROUND
  • 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.

    PMID: 17765329BACKGROUND
  • 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.

    PMID: 20223924BACKGROUND
  • 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.

    PMID: 26157723BACKGROUND
  • 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.

    PMID: 15765197BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisFatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cagla Ozkul

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
To ensure blinding, the assessor physiotherapist will not be aware of the arm to which the subjects belong
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, controlled, single-blind trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 19, 2018

Study Start

September 3, 2018

Primary Completion

October 18, 2019

Study Completion

October 21, 2019

Last Updated

October 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations