Ozone Exposure and Exercise Intensity

Overseen By Matthew G Skirrow, BSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Michael Koehle

Must be taking: Hormonal birth control

Disqualifiers: Smoking history, Respiratory disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how exercise intensity and ozone exposure affect lung health. Researchers seek to determine whether short, intense workouts with ozone (a gas commonly found in air pollution) are more harmful than longer, moderate workouts. Participants will exercise under different conditions, some with ozone and some with clean air, to observe changes in breathing and lung function. This trial suits individuals actively involved in endurance sports who meet specific fitness criteria. As an unphased trial, it offers participants the chance to contribute to important research on environmental impacts on athletic performance.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, female participants must be on hormonal birth control.

What prior data suggests that this protocol is safe for participants?

Research shows that breathing in ozone can harm health. Studies have found that it can trigger more asthma attacks, lead to more hospital visits, and even increase the risk of death. Ozone can also cause heart problems and inflammation in the body. During exercise, especially at high intensities, people breathe more deeply and take in more air, which can include pollutants like ozone. This increases exposure to harmful substances during exercise. While exercise is generally beneficial, doing it in areas with high ozone levels can be risky. These findings emphasize the importance of understanding how ozone exposure affects the body, especially during physical activities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover how different levels of exercise intensity affect the body's response to ozone exposure. Unlike typical studies that might focus on medication or therapies, this trial is unique in examining the impact of environmental factors like ozone on exercise performance and health. By understanding these interactions, scientists hope to provide insights into how environmental pollution affects human health, potentially leading to new guidelines for safe exercise practices in polluted areas.

What evidence suggests that this trial's treatments could be effective?

This trial will compare the effects of ozone exposure at different exercise intensities. Studies have shown that inhaling ozone can impair lung and heart function during exercise. Research has indicated that higher daily ozone levels correlate with more asthma attacks and increased hospital visits. In some cases, ozone exposure has been linked to more heart problems. Evidence suggests that even short-term exposure to ozone can temporarily reduce lung function. Overall, ozone exposure is known to make breathing more difficult and increase certain health risks. ^{1 6 7 8 9}

Who Is on the Research Team?

Michael Koehle, MD, PhD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for individuals who can safely perform exercises at varying intensities. Participants must be able to exercise with and without exposure to ozone, as the study aims to understand how different exercise intensities interact with ozone exposure.

Inclusion Criteria

Currently training and/or competing in endurance sport

Taking hormonal birth control (female participants only)

My VO2max is above the required level for my gender.

Exclusion Criteria

I have not had a cold or similar illness in the last 4 weeks.

I currently have symptoms of or am infected with COVID-19.

History of smoking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo body plethysmography, spirometry, and a Step-ramp-step test to determine subject characteristics and exercise thresholds

1 day

1 visit (in-person)

Treatment

Participants perform exercise conditions with and without ozone exposure to assess changes in lung function, subjective symptoms, and breathing mechanics

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ozone

Trial Overview The trial is testing the effects of exercising under different conditions: heavy intensity with ozone, moderate intensity with ozone, and similar exercises in filtered air without ozone. Researchers will measure lung function, symptoms, and breathing mechanics.

How Is the Trial Designed?

Group I: Ozone, Moderate Intensity Experimental Treatment 2 Interventions

Participants will exercise for 75 minutes in the moderate intensity domain while exposed to 180 ppb ozone

Group II: Ozone, High Intensity Experimental Treatment 2 Interventions

Participants will exercise for 45 minutes in the heavy intensity domain while exposed to 180 ppb ozone

Group III: Filtered Air, Moderate Intensity Placebo Group 2 Interventions

Participants will exercise for 75 minutes in the moderate intensity domain while exposed to filtered air

Group IV: Filtered Air, Heavy Intensity Placebo Group 2 Interventions

Participants will exercise for 45 minutes in the heavy intensity domain while exposed to filtered air.

Who Is Running the Clinical Trial?

Michael Koehle

Lead Sponsor

Trials

1

Recruited

20+

Natural Sciences and Engineering Research Council, Canada

Collaborator

Trials

63

Recruited

3,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38660726/

Ozone exposure limits cardiorespiratory function during ... We tested the hypothesis that pulmonary function and exercise capability would be diminished, and symptom development would be increased during peak real-world ...

2. epa.gov epa.gov/ozone-pollution-and-your-patients-health/health-effects-ozone-general-population

Health Effects of Ozone in the General Population Higher daily ozone concentrations are associated with increased asthma attacks, increased hospital admissions, increased daily mortality, and other markers of ...

3. journals.physiology.org journals.physiology.org/doi/full/10.1152/ajpheart.00849.2014

Exposure to medium and high ambient levels of ozone ... Epidemiological evidence suggests that exposure to ozone increases cardiovascular morbidity. However, the specific biological mechanisms mediating ...

4. withpower.com withpower.com/trial/phase-exercise-intensity-8-2024-f04a5

Ozone Exposure and Exercise Intensity · Info for Participants The project will look to investigate whether exercise during ozone exposure performed for a shorter duration at a higher intensity is more harmful than ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2773049225000157

The dose-dependent effect of acute ozone exposure on ... Our results showed that 0.2 ppm ozone was the maximum tolerated dose that elicited a temporal decline in lung function in healthy participants and that BerriQi ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4469877/

Exposure to medium and high ambient levels of ozone ... Inhalation of ozone causes adverse systemic inflammatory and cardiac autonomic effects that may contribute to the cardiovascular mortality associated with ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0360132325004494

Inhalation exposure to indoor air pollutants during moderate Physical exercise increases pollutant inhalation doses, with high-intensity exercise activities resulting in higher exposures compared to ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12028381/

Air Pollution and Endurance Exercise: A Systematic Review of ... This study highlights that exposure to air pollution during endurance activities, such as cycling and outdoor running, significantly affects cardiopulmonary ...

9. nature.com nature.com/articles/s41598-023-28802-x

Impact of air pollution on running performance Training and competing at elevated air pollution levels, even at exposures within AQI's good-to-moderate classifications, was associated with slower race times.