Endothelial DysfunctionCAPaHNCT01708356
Cycling, Air Pollution and Health
A study testing Cycling on a residential route in people with Endothelial Dysfunction and Endothelial Function, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction, Endothelial Function, Cardiovascular Physiological Phenomena
- What is being tested?
- Cycling on a residential route
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 19- 39
- male or female
- able to bicycle comfortably on city streets for 1 hour
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Air Pollution Exposure Lab, Vancouver General Hospital through the School of Population and Public Health, University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
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:
- 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;
- estimate the pollutant dose received by each cyclist, and relate this to the health effects observed; and
- 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
- Being tested
- Cycling on a residential route
- Keywords
- Air Pollution, Particulate Matter, Exercise, Respiratory Rate, Inflammation, Oxidative Stress, Plethysmography
- Medical subject headings
- Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling on a residential routeBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Normal cycling | Experimental | Cycling on a residential and downtown route (crossover design) Receives: Behavioral: Cycling on a residential route |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endothelial function, as measured by peripheral arterial tonometry (EndoPAT) score of reactive hyperemia index (RHI)
Measured: Baseline (1 hour pre-expousre) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
Secondary outcomes (1)
Change in lung function (using spirometry to assess lung function values)
Measured: Baseline (1 hour pre-exposure) and 1 hour post- exposure (plus or minus 30 minutes) to a bicycle ride in an urban environment outdoors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Brauer, ScD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708356
- Sponsor's protocol ID
- H10-00902
- Other IDs
- H1008-111481/001/XSB
- Acronym
- CAPaH
- Status last verified
- Oct 2012
- First submitted
- 9 Oct 2012
- Last updated
- 16 Oct 2012
- Results posted
- No
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.
PubMed 30428890
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cycling, Air Pollution and Health
- ClinicalTrials.gov ID
- NCT01708356
- Acronym / sponsor ID
- CAPaH / H10-00902
- Keywords
- Air Pollution, Particulate Matter, Exercise, Respiratory Rate, Inflammation, Oxidative Stress, Plethysmography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- estimate the pollutant dose received by each cyclist, and relate this to the health effects observed; and
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal cycling | Experimental | Behavioral: Cycling on a residential routeCycling on a residential and downtown route (crossover design) |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 19- 39
- male or female
- able to bicycle comfortably on city streets for 1 hour
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycling on a residential route | Behavioural | Normal cycling |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
- Derived from this study: PubMed 30428890Cole 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Brauer, ScD principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling on a residential route in people with Endothelial Dysfunction and Endothelial Function, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01708356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2012; AzTrials last refreshed its copy on 26 Oct 2026.