An observational study in Multiple Sclerosis, sponsored by Gazi University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-02.
Sponsored by Gazi University · Observational
Among 27 studies in Multiple Sclerosis by Gazi University — none open to participants now, none under way, none of them phase 3. Multiple Sclerosis · Gazi University.
Among the 27 studies in Multiple Sclerosis by Gazi University, this one is the 7th largest by enrollment of the 15 observational ones that give a count, is the only one that started in 2017, is one of 15 observational ones, and was the 1st registered.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
Browse Multiple Sclerosis studies →None of the 27 studies in Multiple Sclerosis by Gazi University is open now.
Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 1 started in 2017.
This study's enrollment of 70 is below the median of 100 across 970 observational studies indexed under Multiple Sclerosis.
Median enrollment 31 across the 12 interventional studies, 68 across the 15 observational. Of the 26 that completed or were terminated, 0 (0%) have results posted.
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Gazi University is the lead sponsor of 551 studies on the registry; 102 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 27 studies in Multiple Sclerosis by Gazi University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Multiple sclerosis (MS) is a chronic, progressive and unpredictable disease of the central nervous system. In MS, various loss of strength, balance and gait disturbances arise in the central nervous system due to sensory and/or motor neuron degeneration. These disorders lead to limitations in individual activities and participation.
Fatigue is as reported one of the most common first three symptoms among patients with MS and affects up to 80% of the patients. Fatigue is defined as the lack of physical and/or mental energy. Sometimes fatigue can reduce the quality of life by leaving other disorders behind. The most important effect of fatigue is that individuals reduce their physical activity levels. This can lead to the inactivity-related secondary problems being added to the findings of the disease. So the physical capacities of individuals may gradually decrease.
In the literature, there are many studies showing that the level of physical activity of individuals with MS is lower than in healthy individuals. When the investigators analyze the studies that investigate the relation between fatigue and physical activity levels, it is seen that there is the single study about this subject in the literature.
As a result, additional studies are needed to investigate the level of physical activity and the factors affecting it in individuals with MS. Therefore, the investigators planned this study to investigate the relationship between fatigue and physical activity levels in patients with MS.
According to sample size calculation 37 diagnosed Multiple Sclerosis patients and 37 healthy individuals will be included.The demographic characteristics of the participants initially will be taken and Expanded Disability Status Scale score of those of MS will be recorded. Then, fatigue severity and perception, physical activity level, balance, peripheral muscle strength, functional mobility, functional exercise capacity will be evaluated. Primary outcomes are fatigue and physical activity level; secondary outcomes are balance, peripheral muscle strength, functional mobility, functional exercise capacity.
Power analysis was performed using "G * Powerversion3.1 program" in order to determine the minimum number of subjects to be taken into operation. Accordingly, the number of participants in the study group (n) = 37 (α: 0.05, for power 80%) and in the control group (n) = 37).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Multiple sclerosis patients included in this study. Inclusion and exclusion criteria were considered.
Those without chronic disease were included in the study. Inclusion and exclusion criteria were considered.
Fatigue severity
Fatigue Severity Scale
Time frame: Five minutes
Fatigue
Fatigue Impact Scale
Time frame: Eight minutes
Physical activity behavior
Evaluated using an ActiGraph (GT3X+)
Time frame: Three days
Physical activity
International Physical Activity Questionnaire
Time frame: Five minutes
Functional exercise capacity
Evaluated using 6-minute walking test
Time frame: Fifteen minutes
Balance
Evaluated using Bio Sway \[(BSS) Biodex Inc.,Shirley, New York\]
Time frame: Fifteen minutes
Functional Mobility
Evaluated using Time and Go test
Time frame: Two minutes
Muscle strength
Evaluated using digital hand dynamometer
Time frame: Fifteen minutes
Plan to share: No — There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared
Ran from Mar 2017 to primary completion in Jul 2018, 15 months.
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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