UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060007 |
|---|---|
| Receipt number | R000068632 |
| Scientific Title | Impact of Facial Expression Control During Exercise on the Development of Exercise-Induced Brain Fatigue |
| Date of disclosure of the study information | 2025/12/08 |
| Last modified on | 2025/12/08 08:04:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Impact of Facial Expression Control During Exercise on the Development of Exercise-Induced Brain Fatigue
Acronym
Impact of Facial Expression Control During Exercise on the Development of Exercise-Induced Brain Fatigue
Scientific Title
Impact of Facial Expression Control During Exercise on the Development of Exercise-Induced Brain Fatigue
Scientific Title:Acronym
Impact of Facial Expression Control During Exercise on the Development of Exercise-Induced Brain Fatigue
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been shown that facial expressions during exercise, particularly movements of the mouth, are associated with decreases in subjective arousal. However, it remains unclear whether controlling facial expressions can suppress decreases in subjective arousal and the development of brain fatigue. The present study aims to clarify whether intentionally keeping the mouth closed during exercise can attenuate reductions in subjective arousal and brain fatigue.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Executive function task performance before and after exercise, and heart rate, ratings of perceived exertion, subjective arousal, and peripheral blood lactate concentration during exercise
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
the condition in which participants intentionally keep their mouth closed during exercise
Interventions/Control_2
the condition in which participants intentionally keep their mouth open during exercise
Interventions/Control_3
the condition in which no specific instructions are given regarding mouth movements
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
individuals who volunteered to participate in response to email recruitment or announcements posted on the website
Key exclusion criteria
individuals with psychiatric disorders or color blindness (as the executive function task involves color stimuli)
Target sample size
30
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 Sport
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 | Genta |
| Middle name | |
| Last name | Ochi |
Organization
Niigata University of Health and Welfare
Division name
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
025257-4456
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 | 12 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | 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
| 2025 | Year | 12 | Month | 08 | Day |
Last modified on
| 2025 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068632
