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Clinical Trials/NCT03255460
NCT03255460
Completed
Not Applicable

Investigation of the Relationship Between Fatigue and Physical Activity Level in Patients With Multiple Sclerosis

Gazi University1 site in 1 country70 target enrollmentMarch 27, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Gazi University
Enrollment
70
Locations
1
Primary Endpoint
Fatigue
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 27, 2017
End Date
July 4, 2018
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kader Eldemir

Research Asisstant

Gazi University

Eligibility Criteria

Inclusion Criteria

  • 18-65 years of age
  • Having a diagnosis of "Multiple Sclerosis" by a specialist physician
  • Relapse free in the last 3 mounts
  • Having an ambulatory status (Expanded Disability Status Scale score ≤ 6 )
  • No diagnosis of depression

Exclusion Criteria

  • Any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research

Outcomes

Primary Outcomes

Fatigue

Time Frame: Eight minutes

Fatigue Impact Scale

Fatigue severity

Time Frame: Five minutes

Fatigue Severity Scale

Physical activity behavior

Time Frame: Three days

Evaluated using an ActiGraph (GT3X+)

Physical activity

Time Frame: Five minutes

International Physical Activity Questionnaire

Secondary Outcomes

  • Balance(Fifteen minutes)
  • Functional Mobility(Two minutes)
  • Muscle strength(Fifteen minutes)
  • Functional exercise capacity(Fifteen minutes)

Study Sites (1)

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