Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2026-02-17 @ 5:50 PM
Study NCT ID:
NCT06019156
Status:
COMPLETED
Last Update Posted:
2023-08-31
First Post:
2023-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Metaverse Space-based Exercise Video Distribution in Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2023-08-06', 'studyFirstSubmitQcDate': '2023-08-24', 'lastUpdatePostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical activity', 'timeFrame': 'The pre-measurement answered the most recent week, and the post-measurement responded to the next week after the 8 weeks intervention was finished.', 'description': 'The short form of the International Physical Activity Questionnaire Short Form was used to measure the effect of an intervention.'}], 'secondaryOutcomes': [{'measure': 'Well-being', 'timeFrame': 'Pre- and post- 8 weeks intervention', 'description': 'The Japanese version of the World Health Organization Five-Well-Being Index was used.'}, {'measure': 'Psychological distress', 'timeFrame': 'Pre- and post- 8 weeks intervention', 'description': 'The 6-item Kessler Scale as a nonspecific psychological distress scale was used.'}, {'measure': 'Locomotive syndrome risk tests', 'timeFrame': 'Pre- and post- 8 weeks intervention', 'description': 'We used the 25-question geriatric locomotive function scale.'}, {'measure': 'Social capital', 'timeFrame': 'Pre- and post- 8 weeks intervention', 'description': 'The social capital questions consisted of 11 items related to civic participation, social cohesion, and reciprocity, with a perfect score of 11 and higher scores indicating stronger social connections.'}, {'measure': 'Quality of life (QOL)', 'timeFrame': 'Pre- and post- 8 weeks intervention', 'description': 'The Japanese version of the 26-item World Health Organization QOL measure was used to assess QOL.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '38227355', 'type': 'DERIVED', 'citation': 'Mizuta R, Maeda N, Tashiro T, Suzuki Y, Kuroda S, Ishida A, Oda S, Watanabe T, Tamura Y, Komiya M, Urabe Y. Effectiveness of Metaverse Space-Based Exercise Video Distribution in Young Adults: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Jan 16;12:e46397. doi: 10.2196/46397.'}]}, 'descriptionModule': {'briefSummary': 'This study explored whether exercise video distribution using metaverse space is effective in increasing physical activity among young people, along with mental health and locomotive function. This is a randomized parallel-group study. Participants will be assigned to 3 groups: a metaverse group, a YouTube group, and a control group. The metaverse group will receive eight 10-minute exercise videos each week with approximately 4 to 8 METs (metabolic equivalents of task) in the metaverse space to encourage exercise, and the YouTube group will receive access to the same exercise videos as the metaverse group. The control group was given no specific instructions.\n\nThe intervention period was 8 weeks, and physical activity and other items were measured before and after the intervention. These pre- and post-intervention measurements will be used to determine whether the delivery of exercise videos via Metaverse is effective in increasing physical activity in young adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* individuals aged 18-30 at the time of obtaining consent\n* who owned a smartphone or computer and had internet access\n* who did not belong to an exercise community, such as a sports club\n\nExclusion Criteria:\n\n* individuals who had a history of a disease that prohibited exercise\n* individuals whose physical activity was \\> 3000 metabolic equivalents of task (METs)/week\n* pregnant (or possibly pregnant) women'}, 'identificationModule': {'nctId': 'NCT06019156', 'briefTitle': 'Effectiveness of Metaverse Space-based Exercise Video Distribution in Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Hiroshima University'}, 'officialTitle': 'Effectiveness of Metaverse Space-based Exercise Video Distribution in Young Adults: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'C2022-0044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'metaverse group', 'interventionNames': ['Behavioral: Exercise video distribution of Metaverse']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'YouTube group', 'interventionNames': ['Behavioral: Exercise video distribution of YouTube']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Exercise video distribution of Metaverse', 'type': 'BEHAVIORAL', 'description': 'Participants received a 10-minute exercise video each week with a load of about 4 to 8 metabolic equivalents of task (METs) in the metaverse space, for eight videos delivered to encourage exercise.', 'armGroupLabels': ['metaverse group']}, {'name': 'Exercise video distribution of YouTube', 'type': 'BEHAVIORAL', 'description': 'Participants view exercise videos with the same content as the metaverse group.', 'armGroupLabels': ['YouTube group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima University', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}], 'overallOfficials': [{'name': 'Yukio Urabe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hiroshima University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There are no plans to make Individual Participant Data (IPD) available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hiroshima University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Doctoral student of Graduate School of Biomedical and Health Sciences Hiroshima University', 'investigatorFullName': 'Rami Mizuta', 'investigatorAffiliation': 'Hiroshima University'}}}}