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Trial Outcomes & Findings for Susceptibility of Cardiorespiratory Responses to Ozone During Cycling Exercise (NCT NCT05473000)

NCT ID: NCT05473000

Last Updated: 2025-04-13

Results Overview

Measurement of time (in seconds) to volitional exhaustion on a constant work-rate cycling trial at 110% of previously determined maximal power output.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

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

Results posted on

2025-04-13

Participant Flow

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

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

Participant milestones

Participant milestones
Measure
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.
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).
First Intervention
STARTED
10
10
First Intervention
COMPLETED
10
10
First Intervention
NOT COMPLETED
0
0
Washout (Minimum 72 Hours)
STARTED
10
10
Washout (Minimum 72 Hours)
COMPLETED
10
10
Washout (Minimum 72 Hours)
NOT COMPLETED
0
0
Second Intervention
STARTED
10
10
Second Intervention
COMPLETED
10
10
Second Intervention
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ozone (O3) First, Then Room Air
n=10 Participants
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.
Room Air First, Then Ozone (O3)
n=10 Participants
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).
Total
n=20 Participants
Total of all reporting groups
Age, Customized
Age
28 years
STANDARD_DEVIATION 6 • n=10 Participants
28 years
STANDARD_DEVIATION 6 • n=10 Participants
28 years
STANDARD_DEVIATION 6 • n=20 Participants
Sex: Female, Male
Female
3 Participants
n=10 Participants
4 Participants
n=10 Participants
7 Participants
n=20 Participants
Sex: Female, Male
Male
7 Participants
n=10 Participants
6 Participants
n=10 Participants
13 Participants
n=20 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Canada
10 participants
n=10 Participants
10 participants
n=10 Participants
20 participants
n=20 Participants

PRIMARY outcome

Timeframe: From 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.

Outcome measures

Outcome measures
Measure
Ozone (O3)
n=19 Participants
Participants completed submaximal and maximal exercise during a single study visit exposed to O3 (170ppb) during either intervention period.
Room Air
n=19 Participants
Participants completed submaximal and maximal exercise during a single study visit exposed to room air during either intervention period.
Time-to-exhaustion on Maximal Cycling Bout
209 seconds
Standard Deviation 59
235 seconds
Standard Deviation 81

Adverse Events

Ozone (O3)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Room Air

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Koehle

The University of British Columbia

Phone: 604-822-3838

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place