Clinical trial NCT03594357: Cognitive Functions in Patients With Multiple Sclerosis
Official title: The Relationship of Cognitive Functions to Physical and Personal Factors in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Balance
Cognition
Functional exercise capacity
Fatigue
Sleep quality
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: MS patients who apply to the Neurological Rehabilitation Unit of Gazi University Faculty of Health Sciences will be invited to this study.

Brief summary: Approximately 65% of multiple sclerosis (MS) patients appear to have problems in their cognitive function. Long-term memory is one of the most frequently affected functions in MS patients. Many factors play a role in the deterioration of cognitive functions because of many symptoms of MS.

The aim of this study is to investigate the relationship of cognitive function with physical factors such as balance, functional exercise capacity and personal factors such as fatigue level, mood, sleep quality in patients with MS.

Detailed description: Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The cognitive function, balance, functional exercise capacity, fatigue, mood, sleep quality will be evaluated once.

Investigators will use descriptive statistics and t-tests to compare variables between groups. Investigators will examine the correlations between variables using Pearson bivariate correlations. The significance level is set at p\<0,05.

Eligibility criteria: Inclusion Criteria:

* Participants who 18-65 years of age
* MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month.

Exclusion Criteria:

* Participants who have orthopedic, vision, hearing, or perception problems

Primary outcomes:
measure: cognitive function
timeFrame: baseline
Secondary outcomes:
measure: Balance
timeFrame: baseline
measure: Functional exercise capacity.
timeFrame: baseline
measure: Fatigue
timeFrame: baseline
measure: Mood
timeFrame: baseline
measure: Sleep Quality
timeFrame: baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Cagla Ozkul
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Rao SM, Grafman J, DiGuilio D, et al. Memory dysfunction in multiple sclerosis: its relation toworking memory, semantic encoding and implicit learning.Neuropsychology 1993; 7:364-374
citation: Amato MP, Zipoli V, Portaccio E. Multiple sclerosis-related cognitive changes: a review of cross-sectional and longitudinal studies. J Neurol Sci. 2006 Jun 15;245(1-2):41-6. doi: 10.1016/j.jns.2005.08.019. Epub 2006 Apr 27.
citation: Lynch SG, Parmenter BA, Denney DR. The association between cognitive impairment and physical disability in multiple sclerosis. Mult Scler. 2005 Aug;11(4):469-76. doi: 10.1191/1352458505ms1182oa.
citation: Sandroff BM, Pilutti LA, Benedict RH, Motl RW. Association between physical fitness and cognitive function in multiple sclerosis: does disability status matter? Neurorehabil Neural Repair. 2015 Mar-Apr;29(3):214-23. doi: 10.1177/1545968314541331. Epub 2014 Jul 8.