Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474962
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-04
Brief Title:
Cardiorespiratory Fitness and Health Parameters in E-cigarrete Users Impact of a Short Term Pause in Consumption
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Cardiorespiratory Fitness and Health Parameters in E-cigarrete Users Impact of a Short Term Pause in Consumption
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXERVAPE
Brief Summary:
Goal Investigate the health effects of electronic cigarettes e-cigarettes and whether a short break from using them can improve health
Participants
Up to 148 people 74 who use e-cigarettes and 74 who dont Age and sex will be matched between the groups
Study Design
Two connected studies
Observational Study Compares general health including lung function heart health blood pressure and inflammation of e-cigarette users to non-smokers
Clinical Trial E-cigarette users will be randomly assigned to either
Take a 7-day break from e-cigarettes intervention group Continue using e-cigarettes as usual control group Both groups will have their health measured before and after the 7-day period Main Outcome How well your heart and lungs work during exercise
Other Outcomes Lung function blood vessel function risk factors for heart disease and body measurements
Why is this study important
E-cigarettes are becoming more popular but their health effects are unknown This study will provide new information on whether e-cigarettes harm your health and if quitting for a short time can improve it
This information can be used to create better public health policies about e-cigarettes
Participants
Up to 148 people 74 who use e-cigarettes and 74 who dont Age and sex will be matched between the groups
Study Design
Two connected studies
Observational Study Compares general health including lung function heart health blood pressure and inflammation of e-cigarette users to non-smokers
Clinical Trial E-cigarette users will be randomly assigned to either
Take a 7-day break from e-cigarettes intervention group Continue using e-cigarettes as usual control group Both groups will have their health measured before and after the 7-day period Main Outcome How well your heart and lungs work during exercise
Other Outcomes Lung function blood vessel function risk factors for heart disease and body measurements
Why is this study important
E-cigarettes are becoming more popular but their health effects are unknown This study will provide new information on whether e-cigarettes harm your health and if quitting for a short time can improve it
This information can be used to create better public health policies about e-cigarettes
Detailed Description:
The emergence of electronic smoking devices is a recent and scientifically underexplored phenomenon These devices were initially thought of as a harm-reduction strategy in cigarette smokers a purpose for which there is still no definitive evidence of effectiveness Preliminary but consistent findings in the literature suggest the possibility of detrimental health effects to e-cigarette users Despite being prohibited for sale in the country electronic cigarettes are easily accessible in an unregulated manner The increasing number of users approaching one million according to recent data and the uncertainties regarding the composition manufacturing quality and potential long-term effects of exposure to the vapor they produce make the use of electronic cigarettes an emerging issue in Brazilian public health Based on the aforementioned issues exploring the potential effects of this new health-related behavior is urgent Thus the present proposal describes a research project envisioning the execution of two interconnected studies 1 an observational cross-sectional analysis in an exposed-control design evaluating general health parameters of electronic cigarette users compared to non-smoking control individuals matched by sex and age and 2 an intervention study nested within the first study designed as a randomized clinical trial with electronic cigarette users assigned to a group that will take a 7-day pause from using these devices compared to a control group that will not undergo any intervention The studies were designed with cardiorespiratory fitness - measured by a maximum exercise cardiopulmonary test ergospirometry - as the primary outcome The sample size calculated for the cross-sectional study comprises 148 individuals 74 per group and the intended sample for the randomized clinical trial consists of the 74 electronic cigarette users already recruited for the cross-sectional study The secondary outcomes of both studies are related to cardiorespiratory parameters pulmonary function spirometry vascular function endothelial function and tissue oxygenation cardiovascular risk lipid profile and blood pressure inflammatory markers and anthropometric measurements The statistical analyses will be performed using Analysis of Covariance ANCOVA with physical activity level as a covariate for the cross-sectional study and Generalized Estimating Equations GEE with initial oxygen consumption value as a covariate for the clinical trial The investigators expect that the proposed studies yield new and relevant information regarding the potential harmful effects of electronic cigarettes as well as the possibility of reversing these effects through refraining from their consumption The novelty of the studies the urgency of the topic the boldness of the experimental approaches and the high immediate applicability of the findings are highlighted in this proposal with the potential to support public health policies concerning this relevant issue
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None