<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04438954</url>
  </required_header>
  <id_info>
    <org_study_id>2020</org_study_id>
    <nct_id>NCT04438954</nct_id>
  </id_info>
  <brief_title>Investigation of Fatigue, Physical Activity, Sleep Quality and Anxiety Levels</brief_title>
  <official_title>Investigation of Fatigue, Physical Activity, Sleep Quality and Anxiety Levels of Multiple Sclerosis Patients in the COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara Yildirim Beyazıt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara Yildirim Beyazıt University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hundreds of thousands of confirmed cases have been reported worldwide, just 3 months after&#xD;
      the first patients were identified in Wuhan, China. Just like other members of the community,&#xD;
      MS patients are uncomfortable with the emotional distress and health anxiety caused by the&#xD;
      COVID-19 outbreak. Most MS patients receive immunosuppressive or immunomodulatory therapies.&#xD;
      Patients taking immunosuppressive agents are theoretically at increased risk of being&#xD;
      affected by viral pandemics, and a higher health concern is expected in this group of&#xD;
      patients. Moreover, MS patients lose social support. Patients with increased duration of stay&#xD;
      can no longer access physical and cognitive rehabilitation therapies. We also know that&#xD;
      increased anxiety and sleep disorders can cause MS patients to have an attack.&#xD;
&#xD;
      When literature is examined, it is known that MS patients' physical activity levels decrease,&#xD;
      fatigue, sleep quality and anxiety levels increase, so their quality of life and&#xD;
      participation in daily life activities decrease. MS patients lose social support during the&#xD;
      COVID-19 outbreak. For all these reasons, we think that the fatigue, physical activity level,&#xD;
      anxiety level and sleep disturbances affected before the COVID-19 outbreak will be further&#xD;
      affected for these reasons.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 5, 2020</start_date>
  <completion_date type="Actual">June 18, 2020</completion_date>
  <primary_completion_date type="Actual">June 5, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue</measure>
    <time_frame>4 week</time_frame>
    <description>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 &quot;completely disagree&quot; to 7 &quot;completely agree&quot;. A score of 4 or higher generally indicates severe fatigue</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical activity</measure>
    <time_frame>4 week</time_frame>
    <description>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 (&lt;600 MET-min/week), with low levels of physical activity (600-3000 MET- min/week) and physical activity level that is sufficient (&gt; 3000 MET-min/week)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>4 week</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>4 week</time_frame>
    <description>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.</description>
  </primary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Multiple Sclerosis</condition>
  <condition>Covid-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients with Multiple Sclerosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with a confirmed diagnosis of clinically definite MS, physician-administered&#xD;
             Expanded Disability Status Scale (EDSS) range of 1-5, and following the instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with acute attacks (three months prior to the study) and those included on&#xD;
             the physiotherapy program during the Covid-19 pandemic.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>58 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>Covid-19 pandemic</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Physical activity</keyword>
  <keyword>Sleep quality</keyword>
  <keyword>Anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04438954
org study id: 2020
nct id: NCT04438954
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Only
time perspective: Prospective
measure: Fatigue
time frame: 4 week
description: 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
measure: Physical activity
time frame: 4 week
description: 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)
measure: Sleep quality
time frame: 4 week
description: 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.
measure: Anxiety
time frame: 4 week
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 58 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Fatigue