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

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT03255460
• Lead Sponsor: Gazi University

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.

Study Timeline

• Study Start: 2017-03-27
• Study First Submitted: 2017-08-12
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-21
• Primary Completion: 2018-07-04
• Study Completion: 2018-07-04
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-31
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical activity behavior	Three days	Evaluated using an ActiGraph (GT3X+)
Fatigue	Eight minutes	Fatigue Impact Scale
Physical activity	Five minutes	International Physical Activity Questionnaire
Fatigue severity	Five minutes	Fatigue Severity Scale

Secondary Outcome Measures

Name	Time	Method
Balance	Fifteen minutes	Evaluated using Bio Sway \[(BSS) Biodex Inc.,Shirley, New York\]
Functional Mobility	Two minutes	Evaluated using Time and Go test
Muscle strength	Fifteen minutes	Evaluated using digital hand dynamometer
Functional exercise capacity	Fifteen minutes	Evaluated using 6-minute walking test

Trial Locations

Locations (1)

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation; 🇹🇷 Ankara, Turkey