Cardiorespiratory Fitness or EnduranceNCT07390695
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.
A study testing Gamification of a structured exercise program in people with Cardiorespiratory Fitness or Endurance and Smoking Cessation, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiorespiratory Fitness or Endurance, Smoking Cessation
- What is being tested?
- Gamification of a structured exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 45 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- hardcore smokers (min 20 cigarettes per day)
- being active smokers at least 1 year
- physically active (MET less than 600 MET minutes per week)
Who cannot join
- having any medical conditions that limit them to participation in a program training
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Universitas Gadjah Mada
Yogyakarta, Special Region of Yogyakarta, 55281
About this study
Official title: 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).
- Being tested
- Gamification of a structured exercise program
- Keywords
- exercise, gamification, cardiorespiratory fitness, smoking cessation
- Medical subject headings
- Smoking Cessation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamification of a structured exercise programBehavioural
A structured exercise program with FITT-VP principles is gamified and delivered to 60 physically inactive hardcore smokers.
| Study group | Role | What they receive |
|---|---|---|
| Gamification Team | Experimental | A group of 60 physically inactive hardcore smokers participated in this study using a gamified exercise within 12 12-week intervention. Receives: Behavioral: Gamification of a structured exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Maximal Oxygen Uptake (VO2Max) Measured by the Cooper 12-Minute Run Test
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.
Measured: Baseline (Week 0) and post-intervention (Week 13)
Secondary outcomes (2)
Level of Physical Activity Measured by the World Health Organization Global Physical Activity Questionnaire (GPAQ)
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.
Measured: Baseline (Week 0) and post-intervention (Week 13)
Intention to Quit Smoking Measured by the Intention to Quit Smoking Scale (IQSS)
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.
Measured: Baseline (Week 0) and post-intervention (Week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Sep 2025
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorespiratory Fitness or EnduranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group quasi-experiment. Using one group that is involved in the whole stages of research (pre-test, intervention, post-test, and follow-up).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Hidayat, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390695
- Sponsor's protocol ID
- KE/FK/1453/EC/2024
- Status last verified
- Feb 2026
- First submitted
- 4 Dec 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamified Exercise for Hardcore Smokers: A Quasi-Experimental Protocol for Improving Cardiorespiratory Fitness and Smoking Cessation
- ClinicalTrials.gov ID
- NCT07390695
- Acronym / sponsor ID
- KE/FK/1453/EC/2024
- Keywords
- exercise, gamification, cardiorespiratory fitness, smoking cessation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group quasi-experiment. Using one group that is involved in the whole stages of research (pre-test, intervention, post-test, and follow-up).
| Arm | Type | Receives |
|---|---|---|
| Gamification Team | Experimental | Behavioral: Gamification of a structured exercise programA group of 60 physically inactive hardcore smokers participated in this study using a gamified exercise within 12 12-week intervention. |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- hardcore smokers (min 20 cigarettes per day)
- being active smokers at least 1 year
- physically active (MET less than 600 MET minutes per week)
Key exclusion criteria (1 listed)
- having any medical conditions that limit them to participation in a program training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamification of a structured exercise programA structured exercise program with FITT-VP principles is gamified and delivered to 60 physically inactive hardcore smokers. | Behavioural | Gamification Team |
Primary outcome
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.
2 secondary outcomes
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)
Intention to Quit Smoking Measured by the Intention to Quit Smoking Scale (IQSS)
Time frame: Baseline (Week 0) and post-intervention (Week 13)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamification of a structured exercise program in people with Cardiorespiratory Fitness or Endurance and Smoking Cessation, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Maximal Oxygen Uptake (VO2Max) Measured by the Cooper 12-Minute Run Test (time frame: Baseline (Week 0) and post-intervention (Week 13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.