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

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.

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

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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