UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046147 |
|---|---|
| Receipt number | R000052673 |
| Scientific Title | Exploring the mechanisms of brain function improvement and brain fatigue by exercise under extreme conditions |
| Date of disclosure of the study information | 2021/11/23 |
| Last modified on | 2024/02/01 08:41:55 |
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Basic information
Public title
Exploring the mechanisms of brain function improvement and brain fatigue by exercise under extreme conditions
Acronym
Mechanisms of changes in brain function during exercise under extreme conditions
Scientific Title
Exploring the mechanisms of brain function improvement and brain fatigue by exercise under extreme conditions
Scientific Title:Acronym
Mechanisms of changes in brain function during exercise under extreme conditions
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To use Virtual Reality (VR) as an environment to promote brain function, and heat, cold, and hypoxia as extreme environments, we elucidate the effects and mechanisms of exercise on brain function under each environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate brain activity during cognitive tasks before and after VR, heat, cold, and hypoxic exposure.
Key secondary outcomes
Evaluate cognitive function (executive functioning),brain activity,mood indexes (POMS2,K6,chalder fatigue scale,two-dimensional mood scale),gastrointestinal temperature,heart rate,thermal sensation,and thermal comfort during cognitive tasks before and after VR, heat, cold, and hypoxic exposure.
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
4
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
10 minutes of moderate-intensity exercise (50% VO2max) while wearing the VR
Interventions/Control_2
Heat exposure for 60 min(42C)
Interventions/Control_3
Cold exposure for 60 min(5C)
Interventions/Control_4
Hypoxic exposure for 60 min(equivalent to 3500m altitude, 13% oxygen concentration)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
None of the participants were taking any prescription medication, and none were smokers.
Key exclusion criteria
prescription medication,smoking
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Fujimoto |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
950-3198
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL
025-257-4675
fujimoto@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Fujimoto |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
950-3198
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL
025-257-4675
Homepage URL
fujimoto@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
Shimamicho 1398, Kita-ku, Niigata city, Niigata
Tel
025-257-4675
fujimoto@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
| 2021 | Year | 11 | Month | 23 | 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
| 2021 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2021 | Year | 11 | Month | 23 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052673
