- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
February 2, 2026 updated by: Ahmad Hidayat, Gadjah Mada University
Gamified Exercise for Hardcore Smokers: A Quasi-Experimental Protocol for Improving Cardiorespiratory Fitness and Smoking Cessation
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).
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Special Region of Yogyakarta
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Yogyakarta, Special Region of Yogyakarta, Indonesia, 55281
- Universitas Gadjah Mada
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gamification Team
A group of 60 physically inactive hardcore smokers participated in this study using a gamified exercise within 12 12-week intervention.
|
A structured exercise program with FITT-VP principles is gamified and delivered to 60 physically inactive hardcore smokers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (Week 0) and post-intervention (Week 13)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (Week 0) and post-intervention (Week 13)
|
|
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.
|
Baseline (Week 0) and post-intervention (Week 13)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
December 4, 2025
First Submitted That Met QC Criteria
February 2, 2026
First Posted (Actual)
February 5, 2026
Study Record Updates
Last Update Posted (Actual)
February 5, 2026
Last Update Submitted That Met QC Criteria
February 2, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KE/FK/1453/EC/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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