Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513754
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-25
Brief Title:
Investigating Changes in Responses to Controlled Effective Doses of Ozone at Different Exercise Intensities
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigating Changes in Responses to Controlled Effective Doses of Ozone at Different Exercise Intensities
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 researchers 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 its 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
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 its 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None