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Investigation of Fatigue, Physical Activity, Sleep Quality and Anxiety Levels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04438954
Recruitment Status : Completed
First Posted : June 19, 2020
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Ankara Yildirim Beyazıt University

Brief Summary:

Hundreds of thousands of confirmed cases have been reported worldwide, just 3 months after the first patients were identified in Wuhan, China. Just like other members of the community, MS patients are uncomfortable with the emotional distress and health anxiety caused by the COVID-19 outbreak. Most MS patients receive immunosuppressive or immunomodulatory therapies. Patients taking immunosuppressive agents are theoretically at increased risk of being affected by viral pandemics, and a higher health concern is expected in this group of patients. Moreover, MS patients lose social support. Patients with increased duration of stay can no longer access physical and cognitive rehabilitation therapies. We also know that increased anxiety and sleep disorders can cause MS patients to have an attack.

When literature is examined, it is known that MS patients' physical activity levels decrease, fatigue, sleep quality and anxiety levels increase, so their quality of life and participation in daily life activities decrease. MS patients lose social support during the COVID-19 outbreak. For all these reasons, we think that the fatigue, physical activity level, anxiety level and sleep disturbances affected before the COVID-19 outbreak will be further affected for these reasons.


Condition or disease
Multiple Sclerosis Covid-19

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Investigation of Fatigue, Physical Activity, Sleep Quality and Anxiety Levels of Multiple Sclerosis Patients in the COVID-19 Pandemic
Actual Study Start Date : May 5, 2020
Actual Primary Completion Date : June 5, 2020
Actual Study Completion Date : June 18, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Fatigue [ Time Frame: 4 week ]
    Fatigue was assessed by the Fatigue Severity Scale (FSS). This is a 9-item questionnaire that assesses the effect of fatigue on daily living. Each item is a statement on fatigue that the subject rates from 1 "completely disagree" to 7 "completely agree". A score of 4 or higher generally indicates severe fatigue

  2. Physical activity [ Time Frame: 4 week ]
    Physical activity levels were assessed by the International Physical Activity Questionnaire (IPAQ): short form. The online self-reporting questionnaire consisted of questions investigating the respondents' PA practice in terms of frequencies and durations of sitting, walking, moderate-intensity physical activities and vigorous-intensity physical activities. The MET-minutes per week (MET-min/week) were calculated using the following formula: intensity (MET) x duration x frequency. Physical activity levels were classified as physically inactive (<600 MET-min/week), with low levels of physical activity (600-3000 MET- min/week) and physical activity level that is sufficient (> 3000 MET-min/week)

  3. Sleep quality [ Time Frame: 4 week ]
    The Pittsburgh Sleep Quality Index (PSQI) questionnaire was used to measure sleep quality using an 18-item scale containing seven items that included sleep quality, sleep duration, sleep latency, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction. Each dimension scored between 0-3, with a total score ranging from 0-21, and a higher score indicating lower sleep quality.

  4. Anxiety [ Time Frame: 4 week ]
    The Hospital Anxiety and Depression Scale (HADS) was composed by two subscales (i.e., anxiety and depression), with 7-items each. The anxiety part of HADS was used to evaluate the anxiety levels of the patients. Each dimension scored between 0-3, with a total score ranging from 0-21, and a higher score indicating higher anxiety level.



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Ages Eligible for Study:   21 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with Multiple Sclerosis
Criteria

Inclusion Criteria:

  • patients with a confirmed diagnosis of clinically definite MS, physician-administered Expanded Disability Status Scale (EDSS) range of 1-5, and following the instructions.

Exclusion Criteria:

  • patients with acute attacks (three months prior to the study) and those included on the physiotherapy program during the Covid-19 pandemic.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04438954


Locations
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Turkey
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
Ankara, Turkey
Sponsors and Collaborators
Ankara Yildirim Beyazıt University
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Responsible Party: Ankara Yildirim Beyazıt University
ClinicalTrials.gov Identifier: NCT04438954    
Other Study ID Numbers: 2020
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ankara Yildirim Beyazıt University:
Multiple Sclerosis
Covid-19 pandemic
Fatigue
Physical activity
Sleep quality
Anxiety
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases