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Trial record 1 of 1 for:    NCT01708356
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Cycling, Air Pollution and Health (CAPaH)

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ClinicalTrials.gov Identifier: NCT01708356
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : October 16, 2012
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Tracking Information
First Submitted Date  ICMJE October 9, 2012
First Posted Date  ICMJE October 16, 2012
Last Update Posted Date October 16, 2012
Study Start Date  ICMJE June 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2012)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 15, 2012)
  • 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 ]
  • 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 ]
  • 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Cycling, Air Pollution and Health
Official Title  ICMJE Cycling, Air Pollution and Health
Brief Summary

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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Endothelial Dysfunction
  • Endothelial Function
  • Cardiovascular Physiological Phenomena
Intervention  ICMJE Behavioral: Cycling on a residential route
Study Arms  ICMJE Experimental: Normal cycling
Cycling on a residential and downtown route (crossover design)
Intervention: Behavioral: Cycling on a residential route
Publications * Cole CA, Carlsten C, Koehle M, Brauer M. Particulate matter exposure and health impacts of urban cyclists: a randomized crossover study. Environ Health. 2018 Nov 14;17(1):78. doi: 10.1186/s12940-018-0424-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2012)
38
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 19- 39
  • male or female
  • able to bicycle comfortably on city streets for 1 hour

Exclusion Criteria:

  • Smokers of any substance (smoking more than 1x every 2 weeks)
  • Must be of height to safely ride a test bike (<5'2", >6'5" )
  • Diagnosed asthma or active allergy (hav fever) symptoms
  • Irregular menstrual cycle, pregnant, breastfeeding, non-monocyclic contraceptive medication or device
  • Taking medication for heart or lung condition
  • Answers yes to any questions on physical activity readiness questionnaire (PAR-Q)
  • requires pain medication daily
  • visual or hearing impairment that prevents safe cycling on streets with motor vehicles
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01708356
Other Study ID Numbers  ICMJE H10-00902
H1008-111481/001/XSB ( Other Identifier: UBC CREB )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Brauer, ScD The University of British Columbia
PRS Account University of British Columbia
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP