<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT01708356</url>
  </required_header>
  <id_info>
    <org_study_id>H10-00902</org_study_id>
    <secondary_id>H1008-111481/001/XSB</secondary_id>
    <nct_id>NCT01708356</nct_id>
  </id_info>
  <brief_title>Cycling, Air Pollution and Health</brief_title>
  <acronym>CAPaH</acronym>
  <official_title>Cycling, Air Pollution and Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <brief_summary>
    <textblock>
      Introduction: Cycling is currently promoted at the municipal, provincial and national level&#xD;
      as a form of active transportation that increases physical activity while at the same time&#xD;
      reducing traffic congestion, traffic-related air pollution and greenhouse gas emissions.&#xD;
      While at a population level the health benefits of exercise via cycling are estimated to&#xD;
      substantially exceed any health impacts related to air pollution exposure and injuries from&#xD;
      traffic accidents , cyclists are known to experience elevated exposures to traffic-related&#xD;
      air pollutants. Combined with exposure to elevated concentrations of air pollutants, cyclists&#xD;
      also are subject to substantially increased inhaled doses due to their level of exertion and&#xD;
      consequently increased inhalation rate. Therefore, given that cyclists experience exposures&#xD;
      to relatively high concentrations of traffic-related air pollutants and that their inhalation&#xD;
      of these pollutants is increased, it is important to evaluate the potential health impacts of&#xD;
      this scenario. Research on the potential health impacts related to exercise (cycling) and&#xD;
      urban air pollution exposure can help inform public communication strategies related to air&#xD;
      quality and its health impacts. In addition, as our previous work suggests substantial&#xD;
      variability in air pollution exposures to cyclists that is related to the route type and the&#xD;
      levels of traffic along cycling routes, there is potential for transportation planners to&#xD;
      promote increased cycling by enhancing infrastructure while at the same time developing&#xD;
      routes that also minimize exposure to air pollution. The cyclist population is also&#xD;
      interested in information regarding the air pollution exposures and potential health impacts&#xD;
      related to cycling.&#xD;
&#xD;
      The objective of this study is to investigate the relationship between traffic-related air&#xD;
      pollution exposure, and respiratory and cardiovascular health impacts in commuting cyclists.&#xD;
      Specifically, the investigators propose to:&#xD;
&#xD;
        1. determine commuting cyclists' exposure to traffic-related air pollutants (PM 2.5, PM10,&#xD;
           ultrafine particulate, black carbon) while cycling along two different bicycle routes in&#xD;
           the city of Vancouver;&#xD;
&#xD;
        2. estimate the pollutant dose received by each cyclist, and relate this to the health&#xD;
           effects observed; and&#xD;
&#xD;
        3. determine if there is a change in lung function, endothelial function, and C-reactive&#xD;
           protein level related to the level of air pollution exposure and dose&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">November 2011</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in endothelial function, as measured by peripheral arterial tonometry (EndoPAT) score of reactive hyperemia index (RHI)</measure>
    <time_frame>Baseline (1 hour pre-expousre) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in lung function (using spirometry to assess lung function values)</measure>
    <time_frame>Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in blood levels of C-reactive protein (a marker of systemic inflammation)</measure>
    <time_frame>Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in blood levels of Interleukin-6 (a marker of systemic inflammation)</measure>
    <time_frame>Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in blood levels of 8-hydroxy-2'-deoxyguanosine (8-OHdG)(a marker of oxidative stress)</measure>
    <time_frame>Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Endothelial Dysfunction</condition>
  <condition>Endothelial Function</condition>
  <condition>Cardiovascular Physiological Phenomena</condition>
  <arm_group>
    <arm_group_label>Normal cycling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cycling on a residential and downtown route (crossover design)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cycling on a residential route</intervention_name>
    <arm_group_label>Normal cycling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 19- 39&#xD;
&#xD;
          -  male or female&#xD;
&#xD;
          -  able to bicycle comfortably on city streets for 1 hour&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers of any substance (smoking more than 1x every 2 weeks)&#xD;
&#xD;
          -  Must be of height to safely ride a test bike (&lt;5'2&quot;, &gt;6'5&quot; )&#xD;
&#xD;
          -  Diagnosed asthma or active allergy (hav fever) symptoms&#xD;
&#xD;
          -  Irregular menstrual cycle, pregnant, breastfeeding, non-monocyclic contraceptive&#xD;
             medication or device&#xD;
&#xD;
          -  Taking medication for heart or lung condition&#xD;
&#xD;
          -  Answers yes to any questions on physical activity readiness questionnaire (PAR-Q)&#xD;
&#xD;
          -  requires pain medication daily&#xD;
&#xD;
          -  visual or hearing impairment that prevents safe cycling on streets with motor vehicles&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Brauer, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Air Pollution Exposure Lab, Vancouver General Hospital through the School of Population and Public Health, University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 1Z3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>October 15, 2012</last_update_submitted>
  <last_update_submitted_qc>October 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Air Pollution</keyword>
  <keyword>Particulate Matter</keyword>
  <keyword>Exercise</keyword>
  <keyword>Respiratory Rate</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Oxidative Stress</keyword>
  <keyword>Plethysmography</keyword>
  <pending_results>
    <submitted>November 20, 2018</submitted>
    <returned>March 21, 2019</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/NCT01708356
org study id: H10-00902
secondary id: H1008-111481/001/XSB
nct id: NCT01708356
lead sponsor: 
Introduction: Cycling is currently promoted at the municipal, provincial and national level
      as a form of active transportation that increases physical activity while at the same time
      reducing traffic congestion, traffic-related air pollution and greenhouse gas emissions.
      While at a population level the health benefits of exercise via cycling are estimated to
      substantially exceed any health impacts related to air pollution exposure and injuries from
      traffic accidents , cyclists are known to experience elevated exposures to traffic-related
      air pollutants. Combined with exposure to elevated concentrations of air pollutants, cyclists
      also are subject to substantially increased inhaled doses due to their level of exertion and
      consequently increased inhalation rate. Therefore, given that cyclists experience exposures
      to relatively high concentrations of traffic-related air pollutants and that their inhalation
      of these pollutants is increased, it is important to evaluate the potential health impacts of
      this scenario. Research on the potential health impacts related to exercise (cycling) and
      urban air pollution exposure can help inform public communication strategies related to air
      quality and its health impacts. In addition, as our previous work suggests substantial
      variability in air pollution exposures to cyclists that is related to the route type and the
      levels of traffic along cycling routes, there is potential for transportation planners to
      promote increased cycling by enhancing infrastructure while at the same time developing
      routes that also minimize exposure to air pollution. The cyclist population is also
      interested in information regarding the air pollution exposures and potential health impacts
      related to cycling.

      The objective of this study is to investigate the relationship between traffic-related air
      pollution exposure, and respiratory and cardiovascular health impacts in commuting cyclists.
      Specifically, the investigators propose to:

        1. determine commuting cyclists' exposure to traffic-related air pollutants (PM 2.5, PM10,
           ultrafine particulate, black carbon) while cycling along two different bicycle routes in
           the city of Vancouver;

        2. estimate the pollutant dose received by each cyclist, and relate this to the health
           effects observed; and

        3. determine if there is a change in lung function, endothelial function, and C-reactive
           protein level related to the level of air pollution exposure and dose
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in endothelial function, as measured by peripheral arterial tonometry (EndoPAT) score of reactive hyperemia index (RHI)
time frame: Baseline (1 hour pre-expousre) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
measure: Change in lung function (using spirometry to assess lung function values)
time frame: Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
measure: Change in blood levels of C-reactive protein (a marker of systemic inflammation)
time frame: Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
measure: Change in blood levels of Interleukin-6 (a marker of systemic inflammation)
time frame: Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
measure: Change in blood levels of 8-hydroxy-2'-deoxyguanosine (8-OHdG)(a marker of oxidative stress)
time frame: Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
arm group label: Normal cycling
arm group type: Experimental
description: Cycling on a residential and downtown route (crossover design)
intervention type: Behavioral
intervention name: Cycling on a residential route
arm group label: Normal cycling
criteria: 
gender: All
minimum age: 19 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Brauer, ScD
role: Principal Investigator
affiliation: The University of British Columbia
facility: 
country: Canada
responsible party type: Sponsor
submitted: November 20, 2018
returned: March 21, 2019