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

NCT06474962 | Not Yet Recruiting

• 1 other identifier: 71092523.7.0000.0068
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Electronic Nicotine Delivery Systems

Keywords

vaping; e-cigarette

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Pulmonary function

  Baseline

• Pulmonary function

  7 days

• Endothelial function

  Baseline

• Endothelial function

  7 days

• Lipid profile

  Baseline

Study Arms (2)

Pause

EXPERIMENTAL

Individuals will attempt to halt e-cigarette consumption for 7 days

Behavioral: Pause

Control

NO INTERVENTION

Individuals will continue habits as usual

Interventions

Pause BEHAVIORAL

7 days of no e-cigarette consumption

Pause

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Clinical Hospital of the School of Medicine, University of Sao Paulo

São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Bruno Gualano, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Gualano, PhD

CONTACT

551126618022; gualano@usp.br

Lucas Porto Santos, PhD

CONTACT

5551999636177; lucaspsantos87@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 26, 2024
• Study Start: June 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• 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.
• Access Criteria: E-mail to study's principal investigator requesting data will be analyzed by the study team.

Locations

BR (1)