<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/NCT01712529</url>
  </required_header>
  <id_info>
    <org_study_id>09295-5</org_study_id>
    <nct_id>NCT01712529</nct_id>
  </id_info>
  <brief_title>Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients</brief_title>
  <official_title>Effect of Supervised Physical Exercise on Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of supervised physical exercise on&#xD;
      endothelial function and number of endothelial progenitor cells (EPCs) in patients with&#xD;
      systemic lupus erythematosus, as well as evaluate the effect of supervised physical exercise&#xD;
      on endothelium derived growth factor (VEGF) levels, disease activity, quality of life,&#xD;
      fatigue, perceived exertion and cardiopulmonary exercise test variables.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several studies have shown that cardiovascular morbimortality is more frequent and early in&#xD;
      SLE patients than in the general population and cardiovascular disease is an important cause&#xD;
      of morbidity and mortality in systemic lupus erythematosus patients. Disturbances in&#xD;
      endothelial function are implicated in its pathogenesis. Endothelial function also depends on&#xD;
      endothelial progenitor cells (EPCs) that enhance angiogenesis, promote vascular repair and&#xD;
      have potential as a marker of cardiovascular disease. Systemic lupus erythematosus patients&#xD;
      have endothelial dysfunction and fewer EPCs. There are studies showing improvement of&#xD;
      endothelial function and EPCs after physical exercise program in individuals with heart&#xD;
      failure, diabetes and coronary arterial disease, but there isn't studies evaluating&#xD;
      endothelial function and EPCs after.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2010</start_date>
  <completion_date type="Anticipated">November 2012</completion_date>
  <primary_completion_date type="Anticipated">November 2012</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Endothelial function and endothelial progenitor cells (EPCs) number</measure>
    <time_frame>16 weeks</time_frame>
    <description>Patients were evaluated at baseline and after 16 weeks by high-resolution ultrasound of brachial artery in resting conditions, after reactive hyperaemia (flow-mediated dilation-FMD) and after oral glyceryl trinitrate to assess endothelial function; EPCs were evaluated by flow cytometry using anti-CD34 (cluster of differentiation 34) (FITC), anti-CD133 (PE) and anti-kinase domain receptor (KDR) (APC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>16 weeks</time_frame>
    <description>Short Form-36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular endothelial growth factor (VEGF)</measure>
    <time_frame>16 weeks</time_frame>
    <description>ELISA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease activity</measure>
    <time_frame>16 weeks</time_frame>
    <description>Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>perceived exertion</measure>
    <time_frame>16 weeks</time_frame>
    <description>Borg scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>16 weeks</time_frame>
    <description>Severity fatigue scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ergospirometric variables</measure>
    <time_frame>16 weeks</time_frame>
    <description>Cardiopulmonary exercise test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <arm_group>
    <arm_group_label>Supervised physical exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Walking at speed of the ventilatory threshold-1 heart rate obtained from cardiopulmonary exercise test and monitored by frequency meter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No supervised physical exercise</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention for 16 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supervised physical exercise</intervention_name>
    <description>Women with systemic lupus erythematosus with availability to perform physical exercise were allocated in exercise group (EG) to practice supervised physical exercise for one hour, three times a week for 16 weeks. Those who were not available for this activity were allocated in the control group (CG). Intervention consisted of walking at speed of the ventilatory threshold-1 heart rate obtained from cardiopulmonary exercise test and monitored by frequency meter.</description>
    <arm_group_label>Supervised physical exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female systemic lupus erythematosus patients&#xD;
&#xD;
          -  18 to 45 years of age&#xD;
&#xD;
          -  Fulfilled at least four criteria classification for lupus (ACR criteria, 1997) -&#xD;
             Signed the consent form approved by the ethics committee of the institution&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemoglobin &lt; 10 mg/dL&#xD;
&#xD;
          -  Neuropsychiatric, pulmonary, articular or vascular damage that would prevent the&#xD;
             practice of exercise&#xD;
&#xD;
          -  Coronary disease or heart failure, functional class ≥ II&#xD;
&#xD;
          -  Pulmonary hypertension&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Creatinine ≥ 1.4 mg/dL&#xD;
&#xD;
          -  Body mass index (BMI) ≥ 35 kg/m2&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Uncontrolled hypothyroidism&#xD;
&#xD;
          -  Smoking in the last 12 months&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Menopause&#xD;
&#xD;
          -  Use of statins in the last three months&#xD;
&#xD;
          -  Practice of physical exercise in past three months&#xD;
&#xD;
          -  Overlap with other autoimmune rheumatic diseases, except antiphospholipid syndrome.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emilia I Sato, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>04021051</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 20, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>October 22, 2012</last_update_submitted>
  <last_update_submitted_qc>October 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 23, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Emilia Inoue Sato</investigator_full_name>
    <investigator_title>Professor, PHD</investigator_title>
  </responsible_party>
  <keyword>Systemic lupus erythematosus</keyword>
  <keyword>endothelium</keyword>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>September 8, 2013</submitted>
    <returned>November 19, 2013</returned>
    <submitted>November 25, 2013</submitted>
    <returned>January 13, 2014</returned>
  </pending_results>
  <!-- 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/NCT01712529
org study id: 09295-5
nct id: NCT01712529
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the effect of supervised physical exercise on
      endothelial function and number of endothelial progenitor cells (EPCs) in patients with
      systemic lupus erythematosus, as well as evaluate the effect of supervised physical exercise
      on endothelium derived growth factor (VEGF) levels, disease activity, quality of life,
      fatigue, perceived exertion and cardiopulmonary exercise test variables.
Several studies have shown that cardiovascular morbimortality is more frequent and early in
      SLE patients than in the general population and cardiovascular disease is an important cause
      of morbidity and mortality in systemic lupus erythematosus patients. Disturbances in
      endothelial function are implicated in its pathogenesis. Endothelial function also depends on
      endothelial progenitor cells (EPCs) that enhance angiogenesis, promote vascular repair and
      have potential as a marker of cardiovascular disease. Systemic lupus erythematosus patients
      have endothelial dysfunction and fewer EPCs. There are studies showing improvement of
      endothelial function and EPCs after physical exercise program in individuals with heart
      failure, diabetes and coronary arterial disease, but there isn't studies evaluating
      endothelial function and EPCs after.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Endothelial function and endothelial progenitor cells (EPCs) number
time frame: 16 weeks
description: Patients were evaluated at baseline and after 16 weeks by high-resolution ultrasound of brachial artery in resting conditions, after reactive hyperaemia (flow-mediated dilation-FMD) and after oral glyceryl trinitrate to assess endothelial function; EPCs were evaluated by flow cytometry using anti-CD34 (cluster of differentiation 34) (FITC), anti-CD133 (PE) and anti-kinase domain receptor (KDR) (APC)
measure: Quality of life
time frame: 16 weeks
description: Short Form-36
measure: Vascular endothelial growth factor (VEGF)
time frame: 16 weeks
description: ELISA
measure: Disease activity
time frame: 16 weeks
description: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
measure: perceived exertion
time frame: 16 weeks
description: Borg scale
measure: Fatigue
time frame: 16 weeks
description: Severity fatigue scale
measure: Ergospirometric variables
time frame: 16 weeks
description: Cardiopulmonary exercise test
arm group label: Supervised physical exercise
arm group type: Experimental
description: Walking at speed of the ventilatory threshold-1 heart rate obtained from cardiopulmonary exercise test and monitored by frequency meter.
arm group label: No supervised physical exercise
arm group type: No Intervention
description: No intervention for 16 weeks
intervention type: Behavioral
intervention name: Supervised physical exercise
description: Women with systemic lupus erythematosus with availability to perform physical exercise were allocated in exercise group (EG) to practice supervised physical exercise for one hour, three times a week for 16 weeks. Those who were not available for this activity were allocated in the control group (CG). Intervention consisted of walking at speed of the ventilatory threshold-1 heart rate obtained from cardiopulmonary exercise test and monitored by frequency meter.
arm group label: Supervised physical exercise
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Emilia I Sato, MD, PhD
role: Principal Investigator
affiliation: Federal University of Sao Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Emilia Inoue Sato
investigator title: Professor, PHD
mesh term: Lupus Erythematosus, Systemic
submitted: September 8, 2013
returned: November 19, 2013
submitted: November 25, 2013
returned: January 13, 2014