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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046147
Receipt No. 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 2021/11/23

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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
Email 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
Email fujimoto@nuhw.ac.jp

Sponsor
Institute Niigata University of Health and Welfare
Institute
Department

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
Email 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
2021 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052673

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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