UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052791 |
|---|---|
| Receipt number | R000060242 |
| Scientific Title | Influence of residence in a mild hyperbaric oxygen environment on oxygen uptake during exercise |
| Date of disclosure of the study information | 2023/11/15 |
| Last modified on | 2023/11/13 21:52:59 |
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Basic information
Public title
Influence of residence in a mild hyperbaric oxygen environment on respiratory circulatory function during exercise
Acronym
Mild hyperbaric oxygen environment and respiratory circulatory function
Scientific Title
Influence of residence in a mild hyperbaric oxygen environment on oxygen uptake during exercise
Scientific Title:Acronym
Residence in a mild hyperbaric oxygen environment and oxygen uptake
Region
| Japan |
Condition
Condition
Long-distance high school track and field athletes
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is investigate to obtain fundamental insights into the effects of staying in a mild high-altitude oxygen environment on fatigue recovery among long-distance high school track and field athletes. The study focuses on comparing VO2max and anaerobic threshold (AT) in real-life and mild high-altitude oxygen environments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The estimated VO2max and anaerobic threshold (AT) were based on the oxygen intake and carbon dioxide output before and after staying in a mild high-altitude oxygen environment.
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Comparison of Evaluation Parameters in Exercise Load Tests between Normal Oxygen Environment and Post-Staying Exercise Load Tests in a Mild High-Altitude Oxygen Environment (2-7 Days Later)
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
| 16 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male
Key inclusion criteria
Male high school students belonging to the men's EKIDEN team (long-distance track and field)
Key exclusion criteria
1. do not regularly use a mild high-altitude oxygen environment for some reason
2. who, due to participating in domestic and international competitions, have been compelled to adopt different lifestyle habits for a certain period.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shigehito |
| Middle name | |
| Last name | Matsubara |
Organization
Kumamoto Health Science University
Division name
Research Center for Health and Sports Science
Zip code
861-5598
Address
325 Izumi-machi, Kita-ku, Kumamoto-shi, Kumamoto
TEL
096-275-2111
matubara@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Shigehito |
| Middle name | |
| Last name | Matsubara |
Organization
Kumamoto Health Science University
Division name
Research Center for Health and Sports Science
Zip code
861-5598
Address
325 Izumi-machi, Kita-ku, Kumamoto-shi, Kumamoto
TEL
096-275-2111
Homepage URL
matubara@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Science University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Health Science University
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
Life Science Ethics Review Committee of Kumamoto Health Science University
Address
325 Izumi-machi, Kita-ku, Kumamoto-shi, Kumamoto
Tel
096-275-2112
kikaku@kumamoto-hsu.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
| 2023 | Year | 11 | Month | 15 | 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
| 2023 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 11 | Month | 13 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060242
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
