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Completed

NCT Number: NCT03255460

The Relationship Between Fatigue and Physical Activity Level in Patients With Multiple Sclerosis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fatigue severity

    Time frame: Five minutes

    Fatigue Severity Scale

  2. Fatigue

    Time frame: Eight minutes

    Fatigue Impact Scale

  3. Physical activity behavior

    Time frame: Three days

    Evaluated using an ActiGraph (GT3X+)

  4. Physical activity

    Time frame: Five minutes

    International Physical Activity Questionnaire

Secondary outcomes

  1. Functional exercise capacity

    Time frame: Fifteen minutes

    Evaluated using 6-minute walking test

  2. Balance

    Time frame: Fifteen minutes

    Evaluated using Bio Sway [(BSS) Biodex Inc.,Shirley, New York]

  3. Functional Mobility

    Time frame: Two minutes

    Evaluated using Time and Go test

  4. Muscle strength

    Time frame: Fifteen minutes

    Evaluated using digital hand dynamometer

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2017
Registry last updated
Apr 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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