Ozone Exposure During Rest and ExerciseNCT05473000
Susceptibility of Cardiorespiratory Responses to Ozone During Cycling Exercise
A study testing Exercise, Ozone and Room air in people with Ozone Exposure During Rest and Exercise, run by University of British Columbia at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ozone Exposure During Rest and Exercise
- What is being tested?
- Exercise, Ozone and Room air
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 18 Aug 2022to 1 Jun 2024
- Phase
- Interventional
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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- History of smoking
- Upper respiratory tract infection within the last 4 weeks
- Presence of any chronic respiratory disease
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 1Z1
About this study
Official title: 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.
- Conditions
- Ozone Exposure During Rest and Exercise
- Being tested
- Exercise, Ozone, Room air
- Keywords
- Ozone, Air pollution, Exercise, Cycling, Susceptibility, Ventilation
- Medical subject headings
- Motor Activity, Disease Susceptibility, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Submaximal and maximal exercise
OzoneOther
Delivery of ozone air pollution at 170ppb
Room airOther
Delivery of room air
| Study group | Role | What they receive |
|---|---|---|
| Ozone (O3) | Experimental | 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. Receives: Behavioral: Exercise; Other: Ozone |
| Room air | Sham comparator | 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. Receives: Behavioral: Exercise; Other: Room air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-exhaustion on Maximal Cycling Bout
Measurement of time (in seconds) to volitional exhaustion on a constant work-rate cycling trial at 110% of previously determined maximal power output.
Measured: From the beginning of the maximal constant work-rate cycling bout until volitional exhaustion occurs (roughly 1-5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start18 Aug 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ozone Exposure During Rest and ExerciseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Principal investigator, Michael Koehle, University of British Columbia
- Investigators
- Michael Koehle, MD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473000
- Sponsor's protocol ID
- H22-01389
- Status last verified
- Mar 2025
- First submitted
- 12 Jul 2022
- Last updated
- 13 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No