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Enrolling by Invitation

NCT Number: NCT07390695

The Researchers Would Like to Conduct a Trial Using Gamified Exercise to Increase Cardiorespiratory Fitness and Intention to Quit Smoking Among Hardcore Smokers Who Are Also Physically Inactive.

The goal of this quasi-experiment is to learn if a gamified exercise works to improve cardiorespiratory fitness in physically inactive hardcore smokers. It will also learn about the effects of smoking cessation. The main questions it aims to answer are:

* Does a gamification of a structured training program improve the cardiorespiratory fitness and smoking cessation behavior among smokers? * Is there any mediating effect from the level of physical activity between a gamified exercise and cardiorespiratory fitness? * Will the smokers engage in the gamified exercise within the 12-week intervention?

This is a no-control group. The quasi-experiment will be conducted within one group (paired data).

Enrolling by Invitation

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Key information

Age range

17 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Gadjah Mada

Yogyakarta, Special Region of Yogyakarta, 55281, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • hardcore smokers (min 20 cigarettes per day)
  • being active smokers at least 1 year
  • physically active (MET less than 600 MET minutes per week)

Exclusion criteria

  • having any medical conditions that limit them to participation in a program training

Treatment and study plan

Gamification of a structured exercise program

Behavioral

A structured exercise program with FITT-VP principles is gamified and delivered to 60 physically inactive hardcore smokers.

Primary outcomes

  1. Estimated Maximal Oxygen Uptake (VO2Max) Measured by the Cooper 12-Minute Run Test

    Time frame: Baseline (Week 0) and post-intervention (Week 13)

    Estimated cardiorespiratory fitness assessed using the Cooper 12-Minute Run Test. Participants are instructed to run or walk as far as possible within 12 minutes. The total distance covered (in meters) is used to estimate maximal oxygen uptake (VO2Max), expressed in milliliters per kilogram per minute (mL/kg/min). Higher VO2Max values indicate better cardiorespiratory fitness.

Secondary outcomes

  1. Level of Physical Activity Measured by the World Health Organization Global Physical Activity Questionnaire (GPAQ)

    Time frame: Baseline (Week 0) and post-intervention (Week 13)

    Physical activity level assessed using the World Health Organization Global Physical Activity Questionnaire (GPAQ). The GPAQ measures physical activity across work, transport, and leisure domains. Total physical activity is calculated in metabolic equivalent task minutes per week (MET-minutes/week). Higher scores indicate higher levels of physical activity.

  2. Intention to Quit Smoking Measured by the Intention to Quit Smoking Scale (IQSS)

    Time frame: Baseline (Week 0) and post-intervention (Week 13)

    Smoking cessation intention was assessed using the Intention to Quit Smoking Scale (IQSS) developed by Söyler and Yorulmaz (2024). The IQSS is a self-reported questionnaire consisting of multiple items rated on a Likert-type scale. Total scores range from 8 to 40, with higher scores indicating a stronger intention to quit smoking.

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Registry information

Official study title

Gamified Exercise for Hardcore Smokers: A Quasi-Experimental Protocol for Improving Cardiorespiratory Fitness and Smoking Cessation

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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