UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054988 |
|---|---|
| Receipt number | R000062827 |
| Scientific Title | Effects of exercise in a virtual reality environment on mental health and cognitive function. |
| Date of disclosure of the study information | 2024/07/19 |
| Last modified on | 2025/10/30 09:19:45 |
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Basic information
Public title
Effects of exercise in a virtual reality environment on brain function
Acronym
Effects of exercise in a virtual reality environment on brain function
Scientific Title
Effects of exercise in a virtual reality environment on mental health and cognitive function.
Scientific Title:Acronym
Effects of exercise in a virtual reality environment on mental health and cognitive function.
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to clarify whether exercise in a virtual reality environment enhances mental health and cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The mood indices POMS2 and K6, TDMS, and subjective exercise intensity are measured immediately before exercise, as well as the cognitive function index Stroop task.
Key secondary outcomes
Heart rate to assess exercise intensity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Wearing VR goggles that expose you to a virtual reality environment, 10 minutes of exercise
Interventions/Control_2
Allow the patient to rest for 10 minutes without VR goggles.
Interventions/Control_3
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
Students who are not colorblind and non-smokers
Key exclusion criteria
Color blindness or are nonsmokers.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ochi |
| Middle name | |
| Last name | Genta |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Health Sciences, Department of Health and Sports
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-City
TEL
025-257-4595
ochi@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Ochi |
| Middle name | |
| Last name | Genta |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Health Sciences, Department of Health and Sports
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-City
TEL
025-257-4595
Homepage URL
ochi@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-City
Tel
035-257-4595
ochi@nuhw.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
| 2024 | Year | 07 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 07 | Month | 17 | Day |
Last modified on
| 2025 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062827
