<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/NCT04439682</url>
  </required_header>
  <id_info>
    <org_study_id>97132852/050.01.04/</org_study_id>
    <nct_id>NCT04439682</nct_id>
  </id_info>
  <brief_title>The Effects of Exercise on Some Biochemical Parameters in Patients With Rheumatoid Arthritis</brief_title>
  <official_title>The Effects of Exercise on Some Biochemical Parameters in Patients With Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gazi 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>
      Background: RA may progress with articular and non-articular involvement.Depression&#xD;
      prevelance is found to increase for RA patients according to healthy population and to be&#xD;
      correlated with pain, decreased quality of life, fatigue and physical disability.BDNF level&#xD;
      was found significantly lower in RA patients with depression. Aim of this study is to&#xD;
      investigate the variation of BDNF, VEGF, TNF- α, IL-6, IL-1β, irisin and α- Klotho levels&#xD;
      following acute exercise.&#xD;
&#xD;
      Methods: This study included 45 RA patients and 45 age and sex matched healthy controls.&#xD;
      Blood samples from all subjects were taken and centrifuged before and immediately after the&#xD;
      exercise intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 17, 2020</start_date>
  <completion_date type="Anticipated">June 17, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 17, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Irisin</measure>
    <time_frame>1 minute</time_frame>
    <description>Blood samples from all subjects will be taken and centrifuged before and immediately after the exercise intervention. Obtained serums will be stored at the laboratories of Firat University.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BDNF, VEGF, TNF- α, IL-6, IL-1β and α- Klotho</measure>
    <time_frame>1 minute</time_frame>
    <description>Blood samples from all subjects will be taken and centrifuged before and immediately after the exercise intervention. Obtained serums will be stored at the laboratories of Firat University.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aerobic exercise will be performed for a single session</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aerobic exercise will be performed to healthy population for a single session</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic exercise</intervention_name>
    <description>Aerobic exercise will be performed to all participants for a single session. Maximum heart rate was calculated for each subject (220 - age) and a heart rate monitor (Polar FT 100, China) will be used to follow subjects' heart rate during aerobic exercise.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who were aged between 18-65 years,&#xD;
&#xD;
          -  Patients who got diagnosed according to American College of Rheumatology criteria&#xD;
&#xD;
          -  Patients who were being followed at Firat University Department of Rheumatology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had regular exercise habits, malignancy, pregnancy, incorporation,&#xD;
&#xD;
          -  Patients who took anti-TNF treatment&#xD;
&#xD;
          -  Patients who had changes of medical treatment in last 3 months&#xD;
&#xD;
          -  Patients who diagnosed with Fibromyalgia Syndrome and Osteoarthritis for lower&#xD;
             extremity&#xD;
&#xD;
          -  Patients who had cardiac symptoms according to New York Heart Association&#xD;
&#xD;
          -  Patients who had dysfunction that can prevent physical activity&#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_contact>
    <last_name>Songul B Yentur</last_name>
    <phone>0424 237 8282</phone>
    <email>songulbaglan23@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Süleyman S Koca, Prof. Dr.</last_name>
    <phone>0424 2370000</phone>
    <phone_ext>0000</phone_ext>
    <email>kocassk@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Songul Baglan Yentur</name>
      <address>
        <city>Elazığ</city>
        <zip>23000</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Songul B Yentur</last_name>
      <phone>+90 506 272 6511</phone>
      <email>songulbaglan23@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Grimsholm O, Rantapaa-Dahlqvist S, Dalen T, Forsgren S. BDNF in RA: downregulated in plasma following anti-TNF treatment but no correlation with inflammatory parameters. Clin Rheumatol. 2008 Oct;27(10):1289-97. doi: 10.1007/s10067-008-0910-4. Epub 2008 May 17.</citation>
    <PMID>18484150</PMID>
  </reference>
  <reference>
    <citation>Szuhany KL, Bugatti M, Otto MW. A meta-analytic review of the effects of exercise on brain-derived neurotrophic factor. J Psychiatr Res. 2015 Jan;60:56-64. doi: 10.1016/j.jpsychires.2014.10.003. Epub 2014 Oct 12.</citation>
    <PMID>25455510</PMID>
  </reference>
  <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 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Firat University</investigator_affiliation>
    <investigator_full_name>Songul Baglan Yentur</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>Biochemical Parameters</keyword>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</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/NCT04439682
org study id: 97132852/050.01.04/
nct id: NCT04439682
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background: RA may progress with articular and non-articular involvement.Depression
      prevelance is found to increase for RA patients according to healthy population and to be
      correlated with pain, decreased quality of life, fatigue and physical disability.BDNF level
      was found significantly lower in RA patients with depression. Aim of this study is to
      investigate the variation of BDNF, VEGF, TNF- α, IL-6, IL-1β, irisin and α- Klotho levels
      following acute exercise.

      Methods: This study included 45 RA patients and 45 age and sex matched healthy controls.
      Blood samples from all subjects were taken and centrifuged before and immediately after the
      exercise intervention.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Irisin
time frame: 1 minute
description: Blood samples from all subjects will be taken and centrifuged before and immediately after the exercise intervention. Obtained serums will be stored at the laboratories of Firat University.
measure: BDNF, VEGF, TNF- α, IL-6, IL-1β and α- Klotho
time frame: 1 minute
description: Blood samples from all subjects will be taken and centrifuged before and immediately after the exercise intervention. Obtained serums will be stored at the laboratories of Firat University.
arm group label: Study group
arm group type: Experimental
description: Aerobic exercise will be performed for a single session
arm group label: Control group
arm group type: Active Comparator
description: Aerobic exercise will be performed to healthy population for a single session
intervention type: Other
intervention name: Aerobic exercise
description: Aerobic exercise will be performed to all participants for a single session. Maximum heart rate was calculated for each subject (220 - age) and a heart rate monitor (Polar FT 100, China) will be used to follow subjects' heart rate during aerobic exercise.
arm group label: Control group
arm group label: Study group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Songul B Yentur
phone: 0424 237 8282
email: songulbaglan23@hotmail.com
last name: Süleyman S Koca, Prof. Dr.
phone: 0424 2370000
phone ext: 0000
email: kocassk@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
citation: Grimsholm O, Rantapaa-Dahlqvist S, Dalen T, Forsgren S. BDNF in RA: downregulated in plasma following anti-TNF treatment but no correlation with inflammatory parameters. Clin Rheumatol. 2008 Oct;27(10):1289-97. doi: 10.1007/s10067-008-0910-4. Epub 2008 May 17.
PMID: 18484150
citation: Szuhany KL, Bugatti M, Otto MW. A meta-analytic review of the effects of exercise on brain-derived neurotrophic factor. J Psychiatr Res. 2015 Jan;60:56-64. doi: 10.1016/j.jpsychires.2014.10.003. Epub 2014 Oct 12.
PMID: 25455510
responsible party type: Principal Investigator
investigator affiliation: Firat University
investigator full name: Songul Baglan Yentur
investigator title: Research Assistant
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No