Cardiorespiratory Fitness and Health Parameters in E-cigarrete Users: Impact of a Short Term Pause in Consumption
NCT Number: NCT06474962
Acronym: EXERVAPE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Electronic Nicotine Delivery Systems
Interventions: BEHAVIORAL: Pause
Sponsor: University of Sao Paulo
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 148
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-06
Completion Date: 2026-04
Locations: Clinical Hospital of the School of Medicine, University of Sao Paulo, Sao Paulo, 05403-000, Brazil

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 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.

Primary Outcome Measures: 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: 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