UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057313 |
|---|---|
| Receipt number | R000065518 |
| Scientific Title | The relationship between the breath-holding ability, chemoreceptor sensitivity, and spleen function in competitive swimmers |
| Date of disclosure of the study information | 2025/03/17 |
| Last modified on | 2025/12/10 17:46:34 |
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Basic information
Public title
The relationship between the breath-holding ability, chemoreceptor sensitivity, and spleen function in competitive swimmers
Acronym
The relationship between the breath-holding ability of competitive swimmers and spleen function
Scientific Title
The relationship between the breath-holding ability, chemoreceptor sensitivity, and spleen function in competitive swimmers
Scientific Title:Acronym
The relationship between the breath-holding ability of competitive swimmers and spleen function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the relationship between the sensitivity of chemoreceptors and spleen function, which are considered important for the breath-holding ability of competitive swimmers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum breath-holding time, ventilatory sensitivity of central and peripheral chemoreceptors, resting spleen volume, and spleen contraction rate during breath-holding
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Maximal breath-holding
Interventions/Control_2
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult swimmers with no respiratory or skin diseases, no history of taking daily medication or smoking
Key exclusion criteria
Has respiratory and skin diseases, takes daily medication, and has a history of smoking
Target sample size
30
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
9503198
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL
0252574675
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
9503198
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL
0252574675
Homepage URL
fujimoto@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Tomomi Fujimoto
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
0252574675
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
| 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
13
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
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 17 | 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 | 03 | Month | 17 | Day |
Last modified on
| 2025 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065518
