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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorUniversity of Sao Paulo

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

14 years of age or older

Reporting using nicotine electronic cigarettes (e-cigarettes)

Serum cotinine levels equal to or greater than 3 ng/mL

Disqualifiers

Contraindications for maximum exercise testing or any of study procedures

Use of any smoking product except e-cigarette (combustible cigarette, cigar, hookah, marijuana, etc.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pause

    Behavioral

    7 days of no e-cigarette consumption

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: PauseExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Maximal oxygen consumption

Maximal cardiorespiratory fitness assessed in a treadmill test

Time frame
Baseline
2

Maximal oxygen consumption

Maximal cardiorespiratory fitness assessed in a treadmill test

Time frame
7 days

Secondary outcomes

1

Pulmonary function

Assessed through spirometry analysis of flow volume loops patterns

Time frame
Baseline
2

Pulmonary function

Assessed through spirometry analysis of flow volume loops patterns

Time frame
7 days
3

Endothelial function

Assessed through ultrasonography of brachial artery

Time frame
Baseline
4

Endothelial function

Assessed through ultrasonography of brachial artery

Time frame
7 days

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: