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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis

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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Multiple Sclerosis individuals; Multiple sclerosis patients included in this study. Inclusion and exclusion criteria were considered.
Healthy individuals; Those without chronic disease were included in the study. Inclusion and exclusion criteria were considered.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Study Chair: Kader Çekim, Pt, Research Assistant; Study Director: Arzu Güçlü Gündüz, Pt, Phd, Associate Professor; Principal Investigator: Ceyla İrkeç, MD, Prof, Professor

Publications and helpful links

Helpful Links

• related info
• related info

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Actual): July 4, 2018
• Study Completion (Actual): July 4, 2018

Study Registration Dates

• First Submitted: August 12, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 2, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Physical Activity; Exercise; Fatigue
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Fatigue
• Other Study ID Numbers: Gazi 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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