NCT07390695

Brief 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. 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Sep 2025Sep 2026

Study Start

First participant enrolled

September 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

December 4, 2025

Last Update Submit

February 2, 2026

Conditions

Keywords

exercisegamificationcardiorespiratory fitnesssmoking cessation

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    Baseline (Week 0) and post-intervention (Week 13)

  • Intention to Quit Smoking Measured by the Intention to Quit Smoking Scale (IQSS)

    Baseline (Week 0) and post-intervention (Week 13)

Study Arms (1)

Gamification Team

EXPERIMENTAL

A group of 60 physically inactive hardcore smokers participated in this study using a gamified exercise within 12 12-week intervention.

Behavioral: Gamification of a structured exercise program

Interventions

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

Gamification Team

Eligibility Criteria

Age17 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThis study is only for male participants.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Gadjah Mada

Yogyakarta, Special Region of Yogyakarta, 55281, Indonesia

Location

MeSH Terms

Conditions

Smoking CessationMotor Activity

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: One group quasi-experiment. Using one group that is involved in the whole stages of research (pre-test, intervention, post-test, and follow-up).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 4, 2025

First Posted

February 5, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations