- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05473000
Susceptibility of Cardiorespiratory Responses to Ozone During Cycling Exercise
March 26, 2025 updated by: Michael Koehle, University of British Columbia
Investigating Susceptibility of Cardiorespiratory Responses to Ozone During Cycling Exercise Based on Resting Ozone Exposure
Ground level ozone (O3) is a common airborne pollutant that is well recognized to cause negative respiratory symptoms and impair pulmonary function.
The proposed study aims to have participants perform submaximal and maximal cycling exercise protocols exposed to both O3 and room air in a crossover design to evaluate how ventilatory patterns, pulmonary function, development of symptoms, and cycling performance are impacted by O3 exposure.
Additionally, the investigators look to compare responses between O3 at rest and during exercise to predict which subjects may be most susceptible to adverse response, as considerable interindividual variability exists.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T 1Z1
- University of British Columbia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 46 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy males between the age of 18 and 50
- Currently training and/or competing in endurance sport
- VO2max >60 ml/kg/min
- Able to communicate sufficiently using the English language
Exclusion Criteria:
- History of smoking
- Upper respiratory tract infection within the last 4 weeks
- Presence of any chronic respiratory disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ozone (O3)
Participants of the experimental group will perform sub-maximal exercise (power output associated with 10% below anaerobic threshold for 30 minutes) and maximal exercise (time-to-exhaustion test at 5% above previously determined maximal power output) on a cycle ergometer while inhaling 170ppb ozone delivered continuously during each exercise session.
|
Submaximal and maximal exercise
Delivery of ozone air pollution at 170ppb
|
|
Sham Comparator: Room air
Participants of the sham group will perform sub-maximal exercise (power output associated with 10% below anaerobic threshold for 30 minutes) and maximal exercise (time-to-exhaustion test at 5% above previously determined maximal power output) on a cycle ergometer while inhaling room air during each exercise session.
|
Submaximal and maximal exercise
Delivery of room air
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time-to-exhaustion on Maximal Cycling Bout
Time Frame: From the beginning of the maximal constant work-rate cycling bout until volitional exhaustion occurs (roughly 1-5 minutes)
|
Measurement of time (in seconds) to volitional exhaustion on a constant work-rate cycling trial at 110% of previously determined maximal power output.
|
From the beginning of the maximal constant work-rate cycling bout until volitional exhaustion occurs (roughly 1-5 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in fraction of exhaled nitric oxide (FeNO)
Time Frame: Immediately and 30-minutes post-exercise and resting ozone exposure
|
Non-invasive airway inflammation biomarker (in part per billion, ppb)
|
Immediately and 30-minutes post-exercise and resting ozone exposure
|
|
Change in dyspnea
Time Frame: Immediately prior to exercise, 10, 20, and 30-minutes into the submaximal constant work-rate cycling bout, immediately and 30-minutes following maximal cycling bout.
|
Feelings of shortness of breath measured via "Modified Borg Dyspnea Scale," where a response of "0" represents no feelings of breathlessness, and a response of "10" indicates maximal breathlessness.
|
Immediately prior to exercise, 10, 20, and 30-minutes into the submaximal constant work-rate cycling bout, immediately and 30-minutes following maximal cycling bout.
|
|
Change in symptoms
Time Frame: Immediately and 30-minutes post-exercise and resting ozone exposure
|
Development of symptoms related to the eyes, nose, throat, or general health, measured via a questionnaire developed by the investigators.
A response of "0" indicates no feelings of the symptom, whereas a response of "5" indicates that the symptom is as bad as the participant has ever experienced it.
|
Immediately and 30-minutes post-exercise and resting ozone exposure
|
|
Change in rating of perceived exertion
Time Frame: 10, 20, and 30-minutes into the submaximal constant work-rate cycling bout
|
Feeling of effort measured via "Borg Rating of Perceived Exertion," measured from 6 to 20.
A response of "6" represents no exertion, while a response of "20" indicates maximal exertion.
|
10, 20, and 30-minutes into the submaximal constant work-rate cycling bout
|
|
Change in blood lactate values
Time Frame: 10, 20, and 30-minutes into the submaximal constant work-rate cycling bout
|
Indication of exercise intensity and energy system contribution via measurement of blood lactate via finger-prick.
|
10, 20, and 30-minutes into the submaximal constant work-rate cycling bout
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Koehle, MD, PhD, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 18, 2022
Primary Completion (Actual)
June 1, 2023
Study Completion (Actual)
June 1, 2024
Study Registration Dates
First Submitted
July 12, 2022
First Submitted That Met QC Criteria
July 21, 2022
First Posted (Actual)
July 25, 2022
Study Record Updates
Last Update Posted (Actual)
April 13, 2025
Last Update Submitted That Met QC Criteria
March 26, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H22-01389
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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