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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03255460
Enrollment
70
Registered
2017-08-21
Start date
2017-03-27
Completion date
2018-07-04
Last updated
2021-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Fatigue, Physical Activity, Exercise

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.

Interventions

None listed

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fatigue severityFive minutesFatigue Severity Scale
FatigueEight minutesFatigue Impact Scale
Physical activity behaviorThree daysEvaluated using an ActiGraph (GT3X+)
Physical activityFive minutesInternational Physical Activity Questionnaire

Secondary

MeasureTime frameDescription
Functional exercise capacityFifteen minutesEvaluated using 6-minute walking test
BalanceFifteen minutesEvaluated using Bio Sway \[(BSS) Biodex Inc.,Shirley, New York\]
Functional MobilityTwo minutesEvaluated using Time and Go test
Muscle strengthFifteen minutesEvaluated using digital hand dynamometer

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026