Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:18 AM
Study NCT ID:
NCT07390695
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-05
First Post:
2025-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'One group quasi-experiment. Using one group that is involved in the whole stages of research (pre-test, intervention, post-test, and follow-up).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2025-12-04', 'studyFirstSubmitQcDate': '2026-02-02', 'lastUpdatePostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated Maximal Oxygen Uptake (VO2Max) Measured by the Cooper 12-Minute Run Test', 'timeFrame': 'Baseline (Week 0) and post-intervention (Week 13)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Level of Physical Activity Measured by the World Health Organization Global Physical Activity Questionnaire (GPAQ)', 'timeFrame': 'Baseline (Week 0) and post-intervention (Week 13)', 'description': '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.'}, {'measure': 'Intention to Quit Smoking Measured by the Intention to Quit Smoking Scale (IQSS)', 'timeFrame': 'Baseline (Week 0) and post-intervention (Week 13)', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'gamification', 'cardiorespiratory fitness', 'smoking cessation'], 'conditions': ['Cardiorespiratory Fitness or Endurance', 'Smoking Cessation']}, 'descriptionModule': {'briefSummary': '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:\n\n* Does a gamification of a structured training program improve the cardiorespiratory fitness and smoking cessation behavior among smokers?\n* Is there any mediating effect from the level of physical activity between a gamified exercise and cardiorespiratory fitness?\n* Will the smokers engage in the gamified exercise within the 12-week intervention?\n\nThis is a no-control group. The quasi-experiment will be conducted within one group (paired data).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '17 Years', 'genderBased': True, 'genderDescription': 'This study is only for male participants.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hardcore smokers (min 20 cigarettes per day)\n* being active smokers at least 1 year\n* physically active (MET less than 600 MET minutes per week)\n\nExclusion Criteria:\n\n* having any medical conditions that limit them to participation in a program training'}, 'identificationModule': {'nctId': 'NCT07390695', 'briefTitle': '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.', 'organization': {'class': 'OTHER', 'fullName': 'Gadjah Mada University'}, 'officialTitle': 'Gamified Exercise for Hardcore Smokers: A Quasi-Experimental Protocol for Improving Cardiorespiratory Fitness and Smoking Cessation', 'orgStudyIdInfo': {'id': 'KE/FK/1453/EC/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gamification Team', 'description': 'A group of 60 physically inactive hardcore smokers participated in this study using a gamified exercise within 12 12-week intervention.', 'interventionNames': ['Behavioral: Gamification of a structured exercise program']}], 'interventions': [{'name': 'Gamification of a structured exercise program', 'type': 'BEHAVIORAL', 'description': 'A structured exercise program with FITT-VP principles is gamified and delivered to 60 physically inactive hardcore smokers.', 'armGroupLabels': ['Gamification Team']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55281', 'city': 'Yogyakarta', 'state': 'Special Region of Yogyakarta', 'country': 'Indonesia', 'facility': 'Universitas Gadjah Mada', 'geoPoint': {'lat': -7.80139, 'lon': 110.36472}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gadjah Mada University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmad Hidayat', 'investigatorAffiliation': 'Gadjah Mada University'}}}}