Susceptibility of Cardiorespiratory Responses to Ozone During Cycling Exercise

NCT ID: NCT05473000

Last Updated: 2025-04-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-18

Study Completion Date

2024-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Ozone Exposure During Rest and Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Submaximal and maximal exercise

Ozone

Intervention Type OTHER

Delivery of ozone air pollution at 170ppb

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.

Group Type SHAM_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

Submaximal and maximal exercise

Room air

Intervention Type OTHER

Delivery of room air

Interventions

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Exercise

Submaximal and maximal exercise

Intervention Type BEHAVIORAL

Ozone

Delivery of ozone air pollution at 170ppb

Intervention Type OTHER

Room air

Delivery of room air

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Natural Sciences and Engineering Research Council, Canada

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Michael Koehle

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Koehle, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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H22-01389

Identifier Type: -

Identifier Source: org_study_id

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