<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/NCT03255460</url>
  </required_header>
  <id_info>
    <org_study_id>Gazi 1</org_study_id>
    <nct_id>NCT03255460</nct_id>
  </id_info>
  <brief_title>The Relationship Between Fatigue and Physical Activity Level in Patients With Multiple Sclerosis</brief_title>
  <official_title>Investigation of the Relationship Between Fatigue and Physical Activity Level in Patients With Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gazi University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multiple sclerosis (MS) is a chronic, progressive and unpredictable disease of the central&#xD;
      nervous system. In MS, various loss of strength, balance and gait disturbances arise in the&#xD;
      central nervous system due to sensory and/or motor neuron degeneration. These disorders lead&#xD;
      to limitations in individual activities and participation.&#xD;
&#xD;
      Fatigue is as reported one of the most common first three symptoms among patients with MS and&#xD;
      affects up to 80% of the patients. Fatigue is defined as the lack of physical and/or mental&#xD;
      energy. Sometimes fatigue can reduce the quality of life by leaving other disorders behind.&#xD;
      The most important effect of fatigue is that individuals reduce their physical activity&#xD;
      levels. This can lead to the inactivity-related secondary problems being added to the&#xD;
      findings of the disease. So the physical capacities of individuals may gradually decrease.&#xD;
&#xD;
      In the literature, there are many studies showing that the level of physical activity of&#xD;
      individuals with MS is lower than in healthy individuals. When the investigators analyze the&#xD;
      studies that investigate the relation between fatigue and physical activity levels, it is&#xD;
      seen that there is the single study about this subject in the literature.&#xD;
&#xD;
      As a result, additional studies are needed to investigate the level of physical activity and&#xD;
      the factors affecting it in individuals with MS. Therefore, the investigators planned this&#xD;
      study to investigate the relationship between fatigue and physical activity levels in&#xD;
      patients with MS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to sample size calculation 37 diagnosed Multiple Sclerosis patients and 37 healthy&#xD;
      individuals will be included.The demographic characteristics of the participants initially&#xD;
      will be taken and Expanded Disability Status Scale score of those of MS will be recorded.&#xD;
      Then, fatigue severity and perception, physical activity level, balance, peripheral muscle&#xD;
      strength, functional mobility, functional exercise capacity will be evaluated. Primary&#xD;
      outcomes are fatigue and physical activity level; secondary outcomes are balance, peripheral&#xD;
      muscle strength, functional mobility, functional exercise capacity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2017</start_date>
  <completion_date type="Actual">July 4, 2018</completion_date>
  <primary_completion_date type="Actual">July 4, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue severity</measure>
    <time_frame>Five minutes</time_frame>
    <description>Fatigue Severity Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Eight minutes</time_frame>
    <description>Fatigue Impact Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical activity behavior</measure>
    <time_frame>Three days</time_frame>
    <description>Evaluated using an ActiGraph (GT3X+)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Five minutes</time_frame>
    <description>International Physical Activity Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional exercise capacity</measure>
    <time_frame>Fifteen minutes</time_frame>
    <description>Evaluated using 6-minute walking test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>Fifteen minutes</time_frame>
    <description>Evaluated using Bio Sway [(BSS) Biodex Inc.,Shirley, New York]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Mobility</measure>
    <time_frame>Two minutes</time_frame>
    <description>Evaluated using Time and Go test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>Fifteen minutes</time_frame>
    <description>Evaluated using digital hand dynamometer</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Multiple Sclerosis individuals</arm_group_label>
    <description>Multiple sclerosis patients included in this study. Inclusion and exclusion criteria were considered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy individuals</arm_group_label>
    <description>Those without chronic disease were included in the study. Inclusion and exclusion criteria were considered.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Power analysis was performed using &quot;G * Powerversion3.1 program&quot; in order to determine the&#xD;
        minimum number of subjects to be taken into operation. Accordingly, the number of&#xD;
        participants in the study group (n) = 37 (α: 0.05, for power 80%) and in the control group&#xD;
        (n) = 37).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 years of age&#xD;
&#xD;
          -  Having a diagnosis of &quot;Multiple Sclerosis&quot; by a specialist physician&#xD;
&#xD;
          -  Relapse free in the last 3 mounts&#xD;
&#xD;
          -  Having an ambulatory status (Expanded Disability Status Scale score ≤ 6 )&#xD;
&#xD;
          -  No diagnosis of depression&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any cardiovascular, orthopedic, visual, hearing and perception problems that may&#xD;
             affect the results of the research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kader Çekim, Pt</last_name>
    <role>Study Chair</role>
    <affiliation>Research assistant</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arzu Güçlü Gündüz, Pt, Phd</last_name>
    <role>Study Director</role>
    <affiliation>Associate professor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ceyla İrkeç, MD, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gazi 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>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Is+Physical+Behavior+Affected+in+Fatigued+Persons+With+Multiple+Sclerosis%3F</url>
    <description>related info</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=Measuring+Activity+Patterns+Using+Actigraphy+in+Multiple+Sclerosis</url>
    <description>related info</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 12, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>March 31, 2021</last_update_submitted>
  <last_update_submitted_qc>March 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gazi University</investigator_affiliation>
    <investigator_full_name>Kader Eldemir</investigator_full_name>
    <investigator_title>Research Asisstant</investigator_title>
  </responsible_party>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_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</ipd_description>
  </patient_data>
  <!-- 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/NCT03255460
org study id: Gazi 1
nct id: NCT03255460
lead sponsor: 
has dmc: No
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.
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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Fatigue severity
time frame: Five minutes
description: Fatigue Severity Scale
measure: Fatigue
time frame: Eight minutes
description: Fatigue Impact Scale
measure: Physical activity behavior
time frame: Three days
description: Evaluated using an ActiGraph (GT3X+)
measure: Physical activity
time frame: Five minutes
description: International Physical Activity Questionnaire
measure: Functional exercise capacity
time frame: Fifteen minutes
description: Evaluated using 6-minute walking test
measure: Balance
time frame: Fifteen minutes
description: Evaluated using Bio Sway [(BSS) Biodex Inc.,Shirley, New York]
measure: Functional Mobility
time frame: Two minutes
description: Evaluated using Time and Go test
measure: Muscle strength
time frame: Fifteen minutes
description: Evaluated using digital hand dynamometer
arm group label: Multiple Sclerosis individuals
description: Multiple sclerosis patients included in this study. Inclusion and exclusion criteria were considered.
arm group label: Healthy individuals
description: Those without chronic disease were included in the study. Inclusion and exclusion criteria were considered.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kader Çekim, Pt
role: Study Chair
affiliation: Research assistant
last name: Arzu Güçlü Gündüz, Pt, Phd
role: Study Director
affiliation: Associate professor
last name: Ceyla İrkeç, MD, Prof
role: Principal Investigator
affiliation: Professor
facility: 
country: Turkey
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Is+Physical+Behavior+Affected+in+Fatigued+Persons+With+Multiple+Sclerosis%3F
description: related info
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=Measuring+Activity+Patterns+Using+Actigraphy+in+Multiple+Sclerosis
description: related info
responsible party type: Principal Investigator
investigator affiliation: Gazi University
investigator full name: Kader Eldemir
investigator title: Research Asisstant
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Fatigue
sharing ipd: No
ipd 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