UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061935 |
|---|---|
| Receipt number | R000070869 |
| Scientific Title | A study on the effect of exercise-induced systemic fatigue on maximum tongue pressure measurements. |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/06/18 18:26:36 |
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Basic information
Public title
Investigation into the effects of exercise-induced general fatigue on maximum tongue pressure.
Acronym
The effect of fatigue on tongue pressure.
Scientific Title
A study on the effect of exercise-induced systemic fatigue on maximum tongue pressure measurements.
Scientific Title:Acronym
The effect of general fatigue on maximum tongue pressure measurement
Region
| Japan |
Condition
Condition
Oral hypofunction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify how tongue pressure is affected when physical fatigue occurs due to exercise.
Basic objectives2
Others
Basic objectives -Others
Identifying factors that affect tongue pressure measurement
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measure maximum tongue pressure immediately before and after exercise and evaluate its changes.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Exercise on a bicycle ergometer for 20 minutes at an intensity that brings your heart rate to approximately 75-80% of your maximum heart rate.
Interventions/Control_2
Rest quietly for 20 minutes and wait.
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
| 41 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18 to under 41
Key exclusion criteria
Individuals with Maximum tongue pressure of less than 20 kPa
Individuals with diseases of the tongue or oral cavity
Individuals with neurological disorders or a history of stroke
Individuals with severe heart disease or respiratory disease
Individuals who are continuously using steroids or other medications that affect muscle strength
Pregnant or breastfeeding individuals
Individuals who have undergone major surgery within 3 months of the study
Individuals who are medically deemed unable to safely undergo the exercise stress test
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kairi |
| Middle name | |
| Last name | Hayashi |
Organization
Institute of Science Tokyo
Division name
Department of Masticatory Function and Health Science
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-city, Tokyo
TEL
0358035522
k.hayashi.spmd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kairi |
| Middle name | |
| Last name | Hayashi |
Organization
Institute of Science Tokyo
Division name
Departmento of Masticatory Function and Health Science
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-city, Tokyo
TEL
0358035522
Homepage URL
k.hayashi.spmd@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
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
Institute of Science Tokyo
Address
1-5-45 Yushima Bunkyo-ku Tokyo, 113-8549
Tel
0358035522
k.hayashi.spmd@tmd.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
東京科学大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 01 | 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
| 2026 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 17 | Day |
Last modified on
| 2026 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070869
