UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048046 |
|---|---|
| Receipt number | R000054454 |
| Scientific Title | Effectiveness of using metaverse space during exercise video delivery to prevent locomotive syndrome in young adults: a randomized controlled trial. |
| Date of disclosure of the study information | 2022/06/13 |
| Last modified on | 2023/12/15 11:39:23 |
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Basic information
Public title
Effectiveness of using metaverse space during exercise video delivery to prevent locomotive syndrome in young adults: a randomized controlled trial
Acronym
Effectiveness of using metaverse space during exercise video delivery to prevent locomotive syndrome in young adults: a randomized controlled trial.
Scientific Title
Effectiveness of using metaverse space during exercise video delivery to prevent locomotive syndrome in young adults: a randomized controlled trial.
Scientific Title:Acronym
Effectiveness of using metaverse space during exercise video delivery to prevent locomotive syndrome in young adults: a randomized controlled trial.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine whether exercise video distribution in a metaverse space, where people can interact with each other through avatars, their own online alter egos, is effective in increasing physical activity, quality of life, subjective well-being, and locomotor function among young adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
International physical activity questionnaire- short form(IPAQ-SF)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise video distribution in metaverse space (3 month)
Interventions/Control_2
Exercise video distribution in metaverse space (3 month)
Interventions/Control_3
No intervention
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Those who are at least 18 years old and less than 30 years old at the time of obtaining consent.
(2) Those who are not in the habit of exercising at least twice a week for 30 minutes each time
(3) Those who own a smartphone or a computer and have access to an Internet environment
(4) Persons who can provide written consent to participate in this study.
Key exclusion criteria
(1) Persons with a disease or a history of a disease that would prohibit exercise
(2) Pregnant women or those who may become pregnant
(3) Any other person deemed inappropriate by the principal investigator or subinvestigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Urabe |
Organization
Graduate school of Hiroshima university
Division name
Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5405
yurabe@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Rami |
| Middle name | |
| Last name | Mizuta |
Organization
Graduate school of Hiroshima university
Division name
Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-6338
Homepage URL
rami-mizuta@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima university
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-seisaku@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
48
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054454
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
