<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/NCT04403438</url>
  </required_header>
  <id_info>
    <org_study_id>10840098-604.01.01-E.14697</org_study_id>
    <nct_id>NCT04403438</nct_id>
  </id_info>
  <brief_title>Familial Mediterranean Fever and Behçet: Analysis Before and After Covid19 Pandemic</brief_title>
  <official_title>Pain, Sleep, Fatigue, Physical Activity Level, Quality of Life and Exercise Habits in Patients With Familial Mediterranean Fever and Behçet: Analysis Before and After Covid19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul 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>
      Behcet' disease (BD) is a chronic inflammatory disease which is characterized by oral and&#xD;
      genital ulcers, uveitis and skin lesions. Musculoskeletal involvement such as arthrits,&#xD;
      arthralgia, enthesis and sacroiliitis can be seen in course of BD. FMF is an autosomal&#xD;
      recessive family disease characterized by abdominal pain, chest pain, joint pain and fever&#xD;
      attacks as a result of inflammation of the serous membranes. FMF patients have been shown to&#xD;
      experience higher levels of pain, fatigue, depression and anxiety than healthy controls, and&#xD;
      this has increased sleep disturbance and reduced quality of life. FMF and BiH have common&#xD;
      characteristics such as ethnicity, etiopathogenetic mechanisms, symptoms, and treatment. In&#xD;
      December 2019, after the officially detected coronavirus (severe acute respiratory syndrome&#xD;
      coranavirus-2 [SARS-CoV-2]) resistant to unknown treatment and rapidly spreading coronavirus&#xD;
      in our country on March 11, 2020 in Hubei province of China, the number of cases increased&#xD;
      rapidly and virus was isolated in 670 patients within 10 days. Ongoing concerns about the&#xD;
      spread of Covid-19 infections have caused many measures to be taken. Among them, social&#xD;
      isolation, home quarantine and avoiding collective places are the most important. In our&#xD;
      country, in the process of social isolation, the areas of movement of Behçet and FMF&#xD;
      patients, like everyone else, were restricted, their stress and anxiety levels increased and&#xD;
      their motivation decreased. The aim of our study is to compare the pain, sleep, fatigue,&#xD;
      physical activity level and quality of life and question exercise habits before and after the&#xD;
      covid-19 outbreak in patients with Behçet and FMF.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Anticipated">June 15, 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>IPAQ-SF</measure>
    <time_frame>one assesment baseline</time_frame>
    <description>The Turkish validity and reliability study of this short questionnaire consisting of seven questions, which evaluates in detail the amount of walking performed in the last week and the amount of moderate and difficult physical activity performed in work, transportation, housework, gardening and leisure activities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Numeric Rating Scale</measure>
    <time_frame>one assesment baseline</time_frame>
    <description>It has horizontal and vertical forms. In this scale, the starting point is the point where there is no pain, and the ending point is the end point where the pain is worst</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short-Form 36 Health Survey (SF-36)</measure>
    <time_frame>one assesment baseline</time_frame>
    <description>It is a scale which was found by Ware in 1987 and examined the quality of life of people. Turkish validity was provided in the study of Koçyiğit et al. The scale consisting of 36 questions was divided into its own subtitles and was made to measure the functional status of the person.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Stage of Change Questionnaire</measure>
    <time_frame>one assesment baseline</time_frame>
    <description>it consists of five questions. The participant is asked to choose only one of these five situations that match the current exercise level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Self-Efficacy Questionnaire</measure>
    <time_frame>one assesment baseline</time_frame>
    <description>This six-point five-point Likert-type scale determines the self-confidence of individuals to begin exercise. The lowest 6 and the highest 30 points are obtained from the scale. The high scores obtained from the scale indicate that the individual trusts him / herself and has a high chance of success in change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decisional Balance Questionnaire</measure>
    <time_frame>one assesment baseline</time_frame>
    <description>Items 2, 4, 6, 8, 10 on a scale consisting of a total of 10 items are expressions designed to evaluate the perceived harm of not exercising, items 1, 3, 5, 7, and 9 are intended to evaluate the perceived benefits of exercising.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Behcet Disease</condition>
  <condition>COVID</condition>
  <condition>FMF</condition>
  <arm_group>
    <arm_group_label>patients with behçet's or fmf</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ıt will be compared pain, sleep, fatigue, physical activity level and quality of life and questioning exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.</intervention_name>
    <description>ıt will be compared pain, sleep, fatigue, physical activity level and quality of life and questioning exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.</description>
    <arm_group_label>patients with behçet's or fmf</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        In patients with Behçet and FMF between the ages of 18-65, exercise habits will be&#xD;
        questioned by comparing pain, sleep, fatigue, physical activity level and quality of life&#xD;
        before and after the covid-19 outbreak.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being between the ages of 18-65&#xD;
&#xD;
          -  Being diagnosed with FMF at least 1 year ago according to diagnostic criteria&#xD;
&#xD;
          -  A diagnosis of BiH at least 1 year ago according to the International Behçet Working&#xD;
             Group&#xD;
&#xD;
          -  Having signed the informed consent form&#xD;
&#xD;
          -  Having a cooperative level that will respond to evaluation scales&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Having other chronic diseases&#xD;
&#xD;
          -  Psychiatric disorders and treated&#xD;
&#xD;
          -  Those with cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>nejla uzun, MSc, Pt</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IstanbulU</name>
      <address>
        <city>Istanbul</city>
        <state>Bakırköy</state>
        <zip>34740</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>May 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 23, 2020</last_update_submitted>
  <last_update_submitted_qc>May 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Nejla Uzun</investigator_full_name>
    <investigator_title>MSc, Pt</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Brucellosis</mesh_term>
    <mesh_term>Behcet Syndrome</mesh_term>
    <mesh_term>Familial Mediterranean Fever</mesh_term>
    <mesh_term>Hereditary Autoinflammatory Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04403438
org study id: 10840098-604.01.01-E.14697
nct id: NCT04403438
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Behcet' disease (BD) is a chronic inflammatory disease which is characterized by oral and
      genital ulcers, uveitis and skin lesions. Musculoskeletal involvement such as arthrits,
      arthralgia, enthesis and sacroiliitis can be seen in course of BD. FMF is an autosomal
      recessive family disease characterized by abdominal pain, chest pain, joint pain and fever
      attacks as a result of inflammation of the serous membranes. FMF patients have been shown to
      experience higher levels of pain, fatigue, depression and anxiety than healthy controls, and
      this has increased sleep disturbance and reduced quality of life. FMF and BiH have common
      characteristics such as ethnicity, etiopathogenetic mechanisms, symptoms, and treatment. In
      December 2019, after the officially detected coronavirus (severe acute respiratory syndrome
      coranavirus-2 [SARS-CoV-2]) resistant to unknown treatment and rapidly spreading coronavirus
      in our country on March 11, 2020 in Hubei province of China, the number of cases increased
      rapidly and virus was isolated in 670 patients within 10 days. Ongoing concerns about the
      spread of Covid-19 infections have caused many measures to be taken. Among them, social
      isolation, home quarantine and avoiding collective places are the most important. In our
      country, in the process of social isolation, the areas of movement of Behçet and FMF
      patients, like everyone else, were restricted, their stress and anxiety levels increased and
      their motivation decreased. The aim of our study is to compare the pain, sleep, fatigue,
      physical activity level and quality of life and question exercise habits before and after the
      covid-19 outbreak in patients with Behçet and FMF.
observational model: Cohort
time perspective: Prospective
measure: IPAQ-SF
time frame: one assesment baseline
description: The Turkish validity and reliability study of this short questionnaire consisting of seven questions, which evaluates in detail the amount of walking performed in the last week and the amount of moderate and difficult physical activity performed in work, transportation, housework, gardening and leisure activities.
measure: Numeric Rating Scale
time frame: one assesment baseline
description: It has horizontal and vertical forms. In this scale, the starting point is the point where there is no pain, and the ending point is the end point where the pain is worst
measure: Short-Form 36 Health Survey (SF-36)
time frame: one assesment baseline
description: It is a scale which was found by Ware in 1987 and examined the quality of life of people. Turkish validity was provided in the study of Koçyiğit et al. The scale consisting of 36 questions was divided into its own subtitles and was made to measure the functional status of the person.
measure: Exercise Stage of Change Questionnaire
time frame: one assesment baseline
description: it consists of five questions. The participant is asked to choose only one of these five situations that match the current exercise level.
measure: Exercise Self-Efficacy Questionnaire
time frame: one assesment baseline
description: This six-point five-point Likert-type scale determines the self-confidence of individuals to begin exercise. The lowest 6 and the highest 30 points are obtained from the scale. The high scores obtained from the scale indicate that the individual trusts him / herself and has a high chance of success in change.
measure: Decisional Balance Questionnaire
time frame: one assesment baseline
description: Items 2, 4, 6, 8, 10 on a scale consisting of a total of 10 items are expressions designed to evaluate the perceived harm of not exercising, items 1, 3, 5, 7, and 9 are intended to evaluate the perceived benefits of exercising.
arm group label: patients with behçet's or fmf
intervention type: Other
intervention name: ıt will be compared pain, sleep, fatigue, physical activity level and quality of life and questioning exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.
description: ıt will be compared pain, sleep, fatigue, physical activity level and quality of life and questioning exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.
arm group label: patients with behçet's or fmf
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: nejla uzun, MSc, Pt
role: Principal Investigator
affiliation: Istanbul University - Cerrahpasa (IUC)
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Nejla Uzun
investigator title: MSc, Pt
mesh term: COVID-19
mesh term: Brucellosis
mesh term: Behcet Syndrome
mesh term: Familial Mediterranean Fever
mesh term: Hereditary Autoinflammatory Diseases
sharing ipd: No