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| Name | Class |
|---|---|
| Natural Sciences and Engineering Research Council, Canada | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Submaximal and maximal exercise |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the beginning of the maximal constant work-rate cycling bout until volitional exhaustion occurs (roughly 1-5 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Koehle, MD, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Vancouver | British Columbia | V6T 1Z1 | Canada |
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22 eligible participants were randomized, with 20 opting to complete the two experimental visits in this crossover design.
24 participants were screened for inclusion by the researchers during an initial study visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 O3 (170ppb). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout (Minimum 72 Hours) |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Room Air First, Then Ozone (O3) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | seconds | From the beginning of the maximal constant work-rate cycling bout until volitional exhaustion occurs (roughly 1-5 minutes) |
|
Adverse events were collected over the testing period (~4 weeks for participants).
All participants were at risk of adverse events due to exposure to low-levels of air pollution (O3) and maximal exercise.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ozone (O3) | Participants who completed submaximal and maximal exercise during exposure to ozone (O3). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Koehle | The University of British Columbia | 604-822-3838 | michael.koehle@ubc.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2024 | Jun 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D004198 | Disease Susceptibility |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D010126 | Ozone |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Air quality (ozone and room air) will be double-blinded; neither participants nor the primary researcher will know the randomized order of the condition.
| Ozone |
| Other |
Delivery of ozone air pollution at 170ppb |
|
| Room air | Other | Delivery of room air |
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| NOT COMPLETED |
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| NOT COMPLETED |
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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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Room Air | Participants who completed submaximal and maximal exercise during exposure to room air. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010100 | Oxygen |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |