<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/NCT02209402</url>
  </required_header>
  <id_info>
    <org_study_id>EC/11/37/257</org_study_id>
    <nct_id>NCT02209402</nct_id>
  </id_info>
  <brief_title>ENdothelial DysfUnction in Renal Disease and Exercise Training</brief_title>
  <acronym>Endure</acronym>
  <official_title>Effect of a 3-month Aerobic Training Program on Endothelial Function in Mild-to-moderate CKD: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiteit Antwerpen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universiteit Antwerpen</source>
  <brief_summary>
    <textblock>
      Chronic kidney disease (CKD) is a prevalent disorder and a major health concern.&#xD;
      Cardiovascular disease is the most prevailing and life-threatening complication observed in&#xD;
      patients with CKD. The diagnosis of CKD places a patient at the highest cardiovascular risk&#xD;
      level irrespective of the stage of renal decline. Therefore, fatal cardiovascular events are&#xD;
      more likely to occur than the evolution to final stages of kidney disease with the need for&#xD;
      dialysis. Counter intuitively, treatment of classical cardiovascular risk factors does not&#xD;
      affect cardiovascular prognosis in CKD, which suggests that the missing link between these&#xD;
      two entities has not been elucidated yet.&#xD;
&#xD;
      In the present project, the investigators focus on endothelial dysfunction in patients with&#xD;
      CKD. Endothelial dysfunction precedes overt atherosclerotic changes by many years. In the&#xD;
      absence of structural changes, endothelial dysfunction is still reversible, which offers&#xD;
      therapeutic perspectives to tackle the progression towards atherosclerosis in an early stage.&#xD;
&#xD;
      The purpose of this study is to determine whether an exercise training program is effective&#xD;
      in ameliorating endothelial dysfunction in patients with chronic kidney disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in brachial artery flow-mediated dilation (FMD= percentage constriction from baseline diameter to minimal occlusion diameter)</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in peak oxygen consumption (ml/kg/min) as marker of aerobic capacity</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in aortic-femoral pulse wave velocity (m/s) as a marker of arterial stiffness</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in augmentation index (%) as a marker of arterial stiffness</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in Intima Media Thickness (µm) of the right common carotid artery</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>change in circulating endothelial progenitor cells (cells/1 million CD45+ events)</measure>
    <time_frame>3 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>change in migratory function of circulating angiogenic cells</measure>
    <time_frame>3 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Training</intervention_name>
    <description>Home-based training programme consisting of daily 4x10 minutes physical exercise on a magnetically braked bicycle at a heart rate corresponding to 80-90% of the heart rate achieved at the anaerobic threshold.</description>
    <arm_group_label>Exercise Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with CKD stage 3-4 (eGFR (15-59 ml/min/1.73m2) without cardiovascular&#xD;
             disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients &lt; 18 years&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  warfarin therapy&#xD;
&#xD;
          -  glucocorticoid therapy&#xD;
&#xD;
          -  clinically active malignant disease&#xD;
&#xD;
          -  heart failure (ejection fraction &lt; 50%)&#xD;
&#xD;
          -  peripheral vascular disease, defined as a history of intermittent claudication,&#xD;
             abnormal peripheral angiography or Doppler ultrasound, lower limb artery bypass&#xD;
             surgery/angioplasty/stenting or non-traumatic lower extremity amputation&#xD;
&#xD;
          -  cerebrovascular disease, defined as a history of transient ischemic attack (TIA) or&#xD;
             stroke, significant stenosis of the A. carotis on ultrasound/CT angiography or carotid&#xD;
             endarterectomy/stenting&#xD;
&#xD;
          -  coronary artery disease (CAD), defined as a history of myocardial infarction, coronary&#xD;
             artery angioplasty/stenting/bypass surgery, significant structural coronary lesions on&#xD;
             angiography or high suspicion of CAD on a maximal exercise test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Antwerp University Hospital</name>
      <address>
        <city>Antwerp</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiteit Antwerpen</investigator_affiliation>
    <investigator_full_name>Amaryllis Van Craenenbroeck</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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/NCT02209402
org study id: EC/11/37/257
nct id: NCT02209402
lead sponsor: 
Chronic kidney disease (CKD) is a prevalent disorder and a major health concern.
      Cardiovascular disease is the most prevailing and life-threatening complication observed in
      patients with CKD. The diagnosis of CKD places a patient at the highest cardiovascular risk
      level irrespective of the stage of renal decline. Therefore, fatal cardiovascular events are
      more likely to occur than the evolution to final stages of kidney disease with the need for
      dialysis. Counter intuitively, treatment of classical cardiovascular risk factors does not
      affect cardiovascular prognosis in CKD, which suggests that the missing link between these
      two entities has not been elucidated yet.

      In the present project, the investigators focus on endothelial dysfunction in patients with
      CKD. Endothelial dysfunction precedes overt atherosclerotic changes by many years. In the
      absence of structural changes, endothelial dysfunction is still reversible, which offers
      therapeutic perspectives to tackle the progression towards atherosclerosis in an early stage.

      The purpose of this study is to determine whether an exercise training program is effective
      in ameliorating endothelial dysfunction in patients with chronic kidney disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Change in brachial artery flow-mediated dilation (FMD= percentage constriction from baseline diameter to minimal occlusion diameter)
time frame: 3 months
measure: change in peak oxygen consumption (ml/kg/min) as marker of aerobic capacity
time frame: 3 months
measure: change in aortic-femoral pulse wave velocity (m/s) as a marker of arterial stiffness
time frame: 3 months
measure: change in augmentation index (%) as a marker of arterial stiffness
time frame: 3 months
measure: change in Intima Media Thickness (µm) of the right common carotid artery
time frame: 3 months
measure: change in circulating endothelial progenitor cells (cells/1 million CD45+ events)
time frame: 3 months
measure: change in migratory function of circulating angiogenic cells
time frame: 3 months
arm group label: Usual Care
arm group type: No Intervention
arm group label: Exercise Training
arm group type: Experimental
intervention type: Behavioral
intervention name: Exercise Training
description: Home-based training programme consisting of daily 4x10 minutes physical exercise on a magnetically braked bicycle at a heart rate corresponding to 80-90% of the heart rate achieved at the anaerobic threshold.
arm group label: Exercise Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universiteit Antwerpen
investigator full name: Amaryllis Van Craenenbroeck
investigator title: Dr.
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic