Multiple Sclerosis Clinical Trial
Official title:
Investigation of the Relationship Between Fatigue and Physical Activity Level in Patients With Multiple Sclerosis
NCT number | NCT03255460 |
Other study ID # | Gazi 1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 27, 2017 |
Est. completion date | July 4, 2018 |
Verified date | March 2021 |
Source | Gazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | July 4, 2018 |
Est. primary completion date | July 4, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation | Ankara |
Lead Sponsor | Collaborator |
---|---|
Gazi University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fatigue severity | Fatigue Severity Scale | Five minutes | |
Primary | Fatigue | Fatigue Impact Scale | Eight minutes | |
Primary | Physical activity behavior | Evaluated using an ActiGraph (GT3X+) | Three days | |
Primary | Physical activity | International Physical Activity Questionnaire | Five minutes | |
Secondary | Functional exercise capacity | Evaluated using 6-minute walking test | Fifteen minutes | |
Secondary | Balance | Evaluated using Bio Sway [(BSS) Biodex Inc.,Shirley, New York] | Fifteen minutes | |
Secondary | Functional Mobility | Evaluated using Time and Go test | Two minutes | |
Secondary | Muscle strength | Evaluated using digital hand dynamometer | Fifteen minutes |
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