Cardiorespiratory Fitness and Health Parameters in E-cigarrete Users: Impact of a Short Term Pause in Consumption (EXERVAPE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Electronic Nicotine Delivery Systems
• Intervention / Treatment: Behavioral: Pause

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 Type: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bruno Gualano, PhD; Phone Number: 551126618022; Email: gualano@usp.br
• Study Contact Backup: Name: Lucas Porto Santos, PhD; Phone Number: 5551999636177; Email: lucaspsantos87@gmail.com

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403-000
    • Clinical Hospital of the School of Medicine, University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 14 years of age or older
• Reporting using nicotine electronic cigarettes (e-cigarettes)
• Serum cotinine levels equal to or greater than 3 ng/mL

Exclusion Criteria:

• Contraindications for maximum exercise testing or any of study procedures
• Use of any smoking product except e-cigarette (combustible cigarette, cigar, hookah, marijuana, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pause; Individuals will attempt to halt e-cigarette consumption for 7 days	Behavioral: Pause; 7 days of no e-cigarette consumption
No Intervention: Control; Individuals will continue habits as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary function	Assessed through spirometry analysis of flow volume loops patterns	Baseline
Pulmonary function	Assessed through spirometry analysis of flow volume loops patterns	7 days
Endothelial function	Assessed through ultrasonography of brachial artery	Baseline
Endothelial function	Assessed through ultrasonography of brachial artery	7 days
Lipid profile	Blood concentrations of HDL cholesterol, LDL cholesterol, total cholesterol and tryglicerides	Baseline
Lipid profile	Blood concentrations of HDL cholesterol, LDL cholesterol, total cholesterol and tryglicerides	7 days
Health-related quality of life	Assessed through "Short-form 36" questionnaire	Baseline
Health-related quality of life	Assessed through "Short-form 36" questionnaire	7 days
Anxiety symptoms	Assessed through Beck's Anxiety Inventory	Baseline
Anxiety symptoms	Assessed through Beck's Anxiety Inventory	7 days
Blood pressure	Office blood pressure measured with automated oscillometric device	Baseline
Inflammatory status	Measured by blood concentration of inflammatory markers: interleukins 6 and 10, interferon-gamma, c-reactive protein and tumoral necrosis factor alpha	Baseline
Inflammatory status	Measured by blood concentration of inflammatory markers: interleukins 6 and 10, interferon-gamma, c-reactive protein and tumoral necrosis factor alpha	7 days

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Bruno Gualano, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: e-cigarette; vaping
• Other Study ID Numbers: 71092523.7.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared in accordance with institutional and legal requirements and will be provided upon reasonable request.
• IPD Sharing Time Frame: Data will be available upon the publication of first study report containing the study's primary outcome and will be kept available indefinitely.
• IPD Sharing Access Criteria: E-mail to study's principal investigator requesting data will be analyzed by the study team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No