Investigating Changes in Responses to Controlled Effective Doses of Ozone at Different Exercise Intensities

NCT ID: NCT06513754

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-08-31

Brief Summary

The project will look to investigate whether exercise during ozone exposure performed for a shorter duration at a higher intensity is more harmful than exercise performed for a longer duration at a lighter intensity. To assess this, participants will perform these exercise conditions with and without ozone exposure and researchers will assess changes in lung function, subjective symptoms, and breathing mechanics to determine which is more harmful.

Detailed Description

Purpose and Hypothesis The purpose of the study is to investigate whether exercise performed at a higher intensity for a shorter duration during ozone exposure results in greater decrements in pulmonary function, subjective symptoms, and dyspnea than low intensity exercise performed for a longer duration. The researcher's hypothesize that high intensity exercise will result in worsened responses as a result of changes to breathing mechanics resulting in greater penetration of ozone into smaller airways of the lungs.

Justification Due to the growing incidence of wildfires, temperature increase with climate change and increased urbanization, more people are exposed to high levels of ozone despite standards set by international and national agencies. Despite health warnings, many choose to continue engaging in exercise during high ozone levels. Results from this study will better inform practitioners and exercisers how to engage in exercise during ozone conditions to minimize it's deleterious effects on health.

Research Design This is a double-blinded randomized cross over design with pre- and post-measures. Ozone status (room air and 180 parts per billion (PPB) ozone) and exercise intensity (moderate and heavy) are the independent variables each with two levels. Testing will take place over 5 laboratory visits separated by at least 7 days. During the first session, subjects will undergo body plethysmography, spirometry, and a Step-ramp-step test on a cycle ergometer to determine subject characteristics and exercise thresholds. During visits 2-5, participants will be randomized to 1 of 4 exercise conditions manipulating exercise intensity and ozone status. They will then be asked to exercise for a duration that incurs the same effective dose of ozone across conditions with ozone exposure. If the participant is exercising in a non-ozone condition, they will be asked to exercise for however long it would take to incur the same effective dose had they been exposed to 180 ppb of ozone during the exercise bout. During the exercise bout, participants will be asked to rate their subjective symptoms associated with ozone exposure, dyspnea, and RPE every 15 minutes. Once the exercise bout is complete, participants will immediately perform pulmonary function testing and will be asked to rate their subjective symptoms associated with ozone exposure, dyspnea, and RPE.

Statistical Analysis To analyze changes in pulmonary function, dyspnea, and subjective symptoms within exercise conditions a repeated measures ANOVA will be conducted. To analyze changes in these variables across conditions relative to ozone status, exercise intensity, sex, and lung size, a multivariate ANOVA will be conducted. To test for significance within and across conditions, a Tukey test will be performed. All data analysis will be conducted in R. The sample size employed for the study will be 18 (n = 9 male, n =9 female)

Conditions

Ozone; Exercise Intensity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Ozone, High Intensity

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

Group Type: EXPERIMENTAL

Ozone

Intervention Type: OTHER

Ozone is a pollutant that forms as a result of nitrogen oxides or volatile organic compounds interacting with UV radiation. Ozone will be created via a generator in the lab

Heavy Intensity

Intervention Type: BEHAVIORAL

Heavy intensity exercise between the first and second ventilatory threshold for 45 minutes

Ozone, Moderate Intensity

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

Group Type: EXPERIMENTAL

Ozone

Intervention Type: OTHER

Ozone is a pollutant that forms as a result of nitrogen oxides or volatile organic compounds interacting with UV radiation. Ozone will be created via a generator in the lab

Moderate Intensity

Intervention Type: BEHAVIORAL

Moderate intensity exercise below the first ventilatory threshold for approximately 75 minutes

Filtered Air, Heavy Intensity

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

Group Type: SHAM_COMPARATOR

Heavy Intensity

Intervention Type: BEHAVIORAL

Heavy intensity exercise between the first and second ventilatory threshold for 45 minutes

Filtered Air

Intervention Type: OTHER

Exposure to filtered air (\<10 ppb ozone)

Filtered Air, Moderate Intensity

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

Group Type: SHAM_COMPARATOR

Moderate Intensity

Intervention Type: BEHAVIORAL

Moderate intensity exercise below the first ventilatory threshold for approximately 75 minutes

Filtered Air

Intervention Type: OTHER

Exposure to filtered air (\<10 ppb ozone)

Interventions

Ozone

Ozone is a pollutant that forms as a result of nitrogen oxides or volatile organic compounds interacting with UV radiation. Ozone will be created via a generator in the lab

Intervention Type: OTHER

Heavy Intensity

Heavy intensity exercise between the first and second ventilatory threshold for 45 minutes

Intervention Type: BEHAVIORAL

Moderate Intensity

Moderate intensity exercise below the first ventilatory threshold for approximately 75 minutes

Intervention Type: BEHAVIORAL

Filtered Air

Exposure to filtered air (\<10 ppb ozone)

Intervention Type: OTHER

Other Intervention Names

O3

Eligibility Criteria

Inclusion Criteria

1. Currently training and/or competing in endurance sport

2. Maximal oxygen consumption (VO2max) greater than 60 ml/kg/min (males) or 50 ml/kg/min (females)

3. Between the ages of 18 and 50

4. Able to communicate sufficiently using the English language

5. Taking hormonal birth control (female participants only)

Exclusion Criteria

1. History of smoking

2. Upper respiratory tract infection within the last 4 weeks

3. EIB, Asthma

4. Presence of any chronic respiratory disease

5. Current symptoms of, or current infection with COVID-19

6. Pregnant or suspected pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Natural Sciences and Engineering Research Council, Canada

OTHER

Sponsor Role: collaborator

Michael Koehle

OTHER

Sponsor Role: lead

Responsible Party

Michael Koehle

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Koehle, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Environmental Physiology Laboratory

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

O3ED

Identifier Type: -

Identifier Source: org_study_id