UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063133 |
|---|---|
| Receipt number | R000072201 |
| Scientific Title | The effect of short-term hypoxia inhalation on subsequent endurance performance |
| Date of disclosure of the study information | 2026/11/15 |
| Last modified on | 2026/10/01 17:56:54 |
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Basic information
Public title
The effect of short-term hypoxia inhalation on subsequent endurance performance
Acronym
The effect of short-term hypoxia inhalation on subsequent endurance performance
Scientific Title
The effect of short-term hypoxia inhalation on subsequent endurance performance
Scientific Title:Acronym
The effect of short-term hypoxia inhalation on subsequent endurance performance
Region
| Japan |
Condition
Condition
Healthy younger
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effect of short-term hypoxia inhalation on subsequent endurance performance and the relationship between hypoxia-induced change in endurance performance and cardiac autonomic nerve activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
exercise time
Key secondary outcomes
VO2peak, heart rate max, heart rate variability, heart rate recovery
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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants are exposed to normobaric hypoxia (FiO2 = 0.13) for 10 min while sitting at rest. After hypoxia inhalation, participants perform incremental exercise on a recumbent ergometer under normoxic conditions. The workload is increased by 20 W/min for males and 15 W/min for females until participants can no longer maintain the required pedaling rate.
Interventions/Control_2
Participants rest for 10 min under normoxic conditions. After hypoxia inhalation, participants perform incremental exercise on a recumbent ergometer under normoxic conditions. The workload is increased by 20 W/min for males and 15 W/min for females until participants can no longer maintain the required pedaling rate.
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Males and females aged 18-30 years old affiliated with Niigata University of Health and Welfare. Participants must have no history of neurological, respiratory, circulatory, musculoskeletal, or metabolic disorders. They must be nonsmokers. They must not have engaged in high-altitude training, hypoxic training, or lived at high altitudes within the past six months. Their levels of depression and sleep quality, as assessed by a questionnaire, must be within normal ranges. They must have stable lifestyle habits.
Key exclusion criteria
Individuals under 18 years of age or 31 years of age or older. Individuals with a history of neurological, respiratory, circulatory, musculoskeletal, or metabolic disorders. Smokers. Individuals who have engaged in high-altitude training, hypoxic training, or lived at high altitudes within the past six months. Individuals whose levels of depression and sleep quality, as assessed by the questionnaire, exceed the cutoff values. Individuals with unstable lifestyle habits.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yudai |
| Middle name | |
| Last name | Yamazaki |
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, Niigata, Japan
TEL
025-257-4538
yudai-yamazaki@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yudai |
| Middle name | |
| Last name | Yamazaki |
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, Niigata, Japan
TEL
025-257-4538
Homepage URL
yudai-yamazaki@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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, Niigata, Japan
Tel
025-257-4538
yudai-yamazaki@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
| 2026 | 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
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 06 | 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 | 10 | Month | 01 | Day |
Last modified on
| 2026 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072201
