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

NCT03255460 | Completed

• 1 other identifier: Gazi 1
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Fatigue; Physical Activity; Exercise

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Functional exercise capacity

  Fifteen minutes

• Balance

  Fifteen minutes

• Functional Mobility

  Two minutes

• Muscle strength

  Fifteen minutes

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Ankara, Turkey (Türkiye)

Location

Related Links

• related info
• related info

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Kader Çekim, Pt

  Research assistant

  STUDY CHAIR

• Arzu Güçlü Gündüz, Pt, Phd

  Associate professor

  STUDY DIRECTOR

• Ceyla İrkeç, MD, Prof

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asisstant

Study Record Dates

• First Submitted: August 12, 2017
• First Posted: August 21, 2017
• Study Start: March 27, 2017
• Primary Completion: July 4, 2018
• Study Completion: July 4, 2018
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)