HealthyNCT06019156
Effectiveness of Metaverse Space-based Exercise Video Distribution in Young Adults
A study testing Exercise video distribution of Metaverse and Exercise video distribution of YouTube in people with Healthy, run by Hiroshima University at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exercise video distribution of Metaverse and Exercise video distribution of YouTube
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteJapan
- Study dates
- 13 Jun 2022to 10 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- individuals aged 18-30 at the time of obtaining consent
- who owned a smartphone or computer and had internet access
- who did not belong to an exercise community, such as a sports club
Who cannot join
- individuals who had a history of a disease that prohibited exercise
- individuals whose physical activity was > 3000 metabolic equivalents of task (METs)/week
- pregnant (or possibly pregnant) women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Metaverse Space-based Exercise Video Distribution in Young Adults: A Randomized Controlled Trial
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.
The 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.
- Conditions
- Healthy
- Being tested
- Exercise video distribution of Metaverse, Exercise video distribution of YouTube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise video distribution of MetaverseBehavioural
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.
Exercise video distribution of YouTubeBehavioural
Participants view exercise videos with the same content as the metaverse group.
| Study group | Role | What they receive |
|---|---|---|
| metaverse group | Experimental | Not described Receives: Behavioral: Exercise video distribution of Metaverse |
| YouTube group | Active comparator | Not described Receives: Behavioral: Exercise video distribution of YouTube |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
The short form of the International Physical Activity Questionnaire Short Form was used to measure the effect of an intervention.
Measured: The pre-measurement answered the most recent week, and the post-measurement responded to the next week after the 8 weeks intervention was finished.
Secondary outcomes (5)
Well-being
The Japanese version of the World Health Organization Five-Well-Being Index was used.
Measured: Pre- and post- 8 weeks intervention
Psychological distress
The 6-item Kessler Scale as a nonspecific psychological distress scale was used.
Measured: Pre- and post- 8 weeks intervention
Locomotive syndrome risk tests
We used the 25-question geriatric locomotive function scale.
Measured: Pre- and post- 8 weeks intervention
Social capital
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.
Measured: Pre- and post- 8 weeks intervention
Quality of life (QOL)
The Japanese version of the 26-item World Health Organization QOL measure was used to assess QOL.
Measured: Pre- and post- 8 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start13 Jun 2022
- Primary completion11 Dec 2022
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rami Mizuta, Hiroshima University
- Investigators
- Yukio Urabe, PhD, Principal investigator, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019156
- Sponsor's protocol ID
- C2022-0044
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to make Individual Participant Data (IPD) available to other researchers.
Publications
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.
PubMed 38227355
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Metaverse Space-based Exercise Video Distribution in Young Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06019156
- Acronym / sponsor ID
- C2022-0044
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 11 Dec 2022 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 31 Aug 2023 (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.
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.
The 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| metaverse group | Experimental | Behavioral: Exercise video distribution of Metaverse |
| YouTube group | Active comparator | Behavioral: Exercise video distribution of YouTube |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- individuals aged 18-30 at the time of obtaining consent
- who owned a smartphone or computer and had internet access
- who did not belong to an exercise community, such as a sports club
Key exclusion criteria (3 listed)
- individuals who had a history of a disease that prohibited exercise
- individuals whose physical activity was > 3000 metabolic equivalents of task (METs)/week
- pregnant (or possibly pregnant) women
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 |
|---|---|---|
| Exercise video distribution of MetaverseParticipants 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. | Behavioural | metaverse group |
| Exercise video distribution of YouTubeParticipants view exercise videos with the same content as the metaverse group. | Behavioural | YouTube group |
Primary outcome
Physical activity
Time frame: The pre-measurement answered the most recent week, and the post-measurement responded to the next week after the 8 weeks intervention was finished.
The short form of the International Physical Activity Questionnaire Short Form was used to measure the effect of an intervention.
5 secondary outcomes
Well-being
Time frame: Pre- and post- 8 weeks intervention
Psychological distress
Time frame: Pre- and post- 8 weeks intervention
Locomotive syndrome risk tests
Time frame: Pre- and post- 8 weeks intervention
Social capital
Time frame: Pre- and post- 8 weeks intervention
Quality of life (QOL)
Time frame: Pre- and post- 8 weeks intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Derived from this study: PubMed 38227355Mizuta 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.
- Individual participant dataSharing planned: No. There are no plans to make Individual Participant Data (IPD) available to other researchers.
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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. This study is not recruiting at the moment.
Yukio Urabe, PhD principal investigator
Hiroshima University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise video distribution of Metaverse and Exercise video distribution of YouTube in people with Healthy, run by Hiroshima University at 1 site in Japan.
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 3 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: finished, as of the sponsor's last update on 31 Aug 2023. 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical activity (time frame: The pre-measurement answered the most recent week, and the post-measurement responded to the next week after the 8 weeks intervention was finished.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06019156, which also lists 1 linked publication.
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 31 Aug 2023.