NCT06474962|Unknown
Cardiorespiratory Fitness and Health Parameters in E-cigarrete Users: Impact of a Short Term Pause in Consumption
EXERVAPE
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EXERVAPE
Sponsor study identifier
interventional
148
1 country
1
Study Start
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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 don't) 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 4, 2024
Actual (reported)June 26, 2024
Actual (reported)April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Maximal oxygen consumption
Maximal cardiorespiratory fitness assessed in a treadmill test
Baseline
Maximal oxygen consumption
Maximal cardiorespiratory fitness assessed in a treadmill test
7 days
Pulmonary function
Baseline
Pulmonary function
7 days
Endothelial function
Baseline
Endothelial function
7 days
Lipid profile
Baseline
Individuals will attempt to halt e-cigarette consumption for 7 days
Individuals will continue habits as usual
7 days of no e-cigarette consumption
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Clinical Hospital of the School of Medicine, University of Sao Paulo
São Paulo, 05403-000, Brazil
Bruno Gualano, PhD
University of Sao Paulo
First Submitted
June 4, 2024
First Posted
June 26, 2024
Study Start
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 2026
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 26, 2024
Record last verified: 2024-06
Data will be shared in accordance with institutional and legal requirements and will be provided upon reasonable request.
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Source: ClinicalTrials.gov.
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