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Susceptibility of Cardiorespiratory Responses to Ozone During Cycling Exercise

Investigating Susceptibility of Cardiorespiratory Responses to Ozone During Cycling Exercise Based on Resting Ozone Exposure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05473000
Enrollment
20
Registered
2022-07-25
Start date
2022-08-18
Completion date
2024-06-01
Last updated
2025-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ozone Exposure During Rest and Exercise

Keywords

Ozone, Air pollution, Exercise, Cycling, Susceptibility, Ventilation

Brief 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 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.

Interventions

BEHAVIORALExercise

Submaximal and maximal exercise

OTHEROzone

Delivery of ozone air pollution at 170ppb

Delivery of room air

Sponsors

Natural Sciences and Engineering Research Council, Canada
CollaboratorOTHER
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Air quality (ozone and room air) will be double-blinded; neither participants nor the primary researcher will know the randomized order of the condition.

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Time-to-exhaustion on Maximal Cycling BoutFrom 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.

Countries

Canada

Participant flow

Recruitment details

24 participants were screened for inclusion by the researchers during an initial study visit.

Pre-assignment details

22 eligible participants were randomized, with 20 opting to complete the two experimental visits in this crossover design.

Participants by arm

ArmCount
Ozone (O3) First, Then Room Air
Participants completed submaximal and maximal exercise during a single study visit exposed to O3 (170ppb). After a 72 hour washout period, they then completed identical procedures exposed to room air.
10
Room Air First, Then Ozone (O3)
Participants completed submaximal and maximal exercise during a single study visit exposed to room air. After a 72 hour washout period, they then completed identical procedures exposed to ozone (O3).
10
Total20

Baseline characteristics

CharacteristicRoom Air First, Then Ozone (O3)TotalOzone (O3) First, Then Room Air
Age, Customized
Age
28 years
STANDARD_DEVIATION 6
28 years
STANDARD_DEVIATION 6
28 years
STANDARD_DEVIATION 6
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Canada
10 participants20 participants10 participants
Sex: Female, Male
Female
4 Participants7 Participants3 Participants
Sex: Female, Male
Male
6 Participants13 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 20
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

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.

Time frame: From the beginning of the maximal constant work-rate cycling bout until volitional exhaustion occurs (roughly 1-5 minutes)

ArmMeasureValue (MEAN)Dispersion
Ozone (O3)Time-to-exhaustion on Maximal Cycling Bout209 secondsStandard Deviation 59
Room AirTime-to-exhaustion on Maximal Cycling Bout235 secondsStandard Deviation 81
p-value: 0.092t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026