UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057307 |
|---|---|
| Receipt number | R000065512 |
| Scientific Title | The Effects of Exercise Under Hypoxic Conditions on Cognitive Function, Facial Expression Changes, and Brain Lactate Concentration |
| Date of disclosure of the study information | 2025/03/17 |
| Last modified on | 2025/10/30 09:22:42 |
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Basic information
Public title
The Effects of Exercise Under Hypoxic Conditions on Cognitive Function, Facial Expression Changes, and Brain Lactate Concentration
Acronym
The Effects of Exercise Under Hypoxic Conditions on Cognitive Function, Facial Expression Changes, and Brain Lactate Concentration
Scientific Title
The Effects of Exercise Under Hypoxic Conditions on Cognitive Function, Facial Expression Changes, and Brain Lactate Concentration
Scientific Title:Acronym
The Effects of Exercise Under Hypoxic Conditions on Cognitive Function, Facial Expression Changes, and Brain Lactate Concentration
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
During acute exercise, not only does physical fatigue occur, but biochemical changes also take place in the brain. Particularly, fluctuations in brain lactate concentration may be related to central fatigue, though invasive methods are required for assessment. While involuntary facial expression changes occur during states of fatigue, the relationship between these changes and biochemical changes in the brain remains unclear. This study investigates the relationship between changes in brain lactate concentration and facial expressions during acute exercise, and examines the possibility that characteristic facial patterns may serve as biomarkers reflecting brain lactate levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function, prefrontal cortex lactate concentration, and action units related to facial expressions, psychological arousal
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
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 under hypoxia
Interventions/Control_2
rest under hypoxia
Interventions/Control_3
Graded exercise test under normoxia
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
Exclusion criteria include individuals without respiratory or color vision abnormalities.
Key exclusion criteria
Exclusion criteria include individuals without respiratory or color vision abnormalities.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Genta |
| Middle name | |
| Last name | Ochi |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
9503198
Address
Shimamimachi 1398, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4595
ochi@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Genta |
| Middle name | |
| Last name | Ochi |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
9503198
Address
Shimamimachi 1398, Kita-ku, Niigata City, Niigata Prefecture
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
Profit organization
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
Shimamimachi 1398, Kita-ku, Niigata City, Niigata Prefecture
Tel
025-257-4455
rinri@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
| 2025 | Year | 03 | Month | 17 | 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
| 2025 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 03 | 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/ctr_e/ctr_view.cgi?recptno=R000065512
