UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062170 |
|---|---|
| Receipt number | R000071146 |
| Scientific Title | Acute Effects of Approximately 4% Hydrogen Inhalation on Exercise-Induced Oxidative Stress, Peripheral Venous Diameter, and Exercise Performance in National-Level Female Rowers: A Single-Blind Fixed-Order Exploratory Pilot Case Series |
| Date of disclosure of the study information | 2026/07/08 |
| Last modified on | 2026/07/08 13:00:50 |
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Basic information
Public title
Exploratory Pilot Study of the Acute Effects of Hydrogen Inhalation on Post-Exercise Oxidative Stress, Vascular Responses, and Exercise Performance in Female Rowers
Acronym
H2-ROW Study
Scientific Title
Acute Effects of Approximately 4% Hydrogen Inhalation on Exercise-Induced Oxidative Stress, Peripheral Venous Diameter, and Exercise Performance in National-Level Female Rowers: A Single-Blind Fixed-Order Exploratory Pilot Case Series
Scientific Title:Acronym
H2-ROW Pilot Study
Region
| Japan |
Condition
Condition
Healthy adult female rowers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to exploratorily evaluate the acute effects of approximately 4% hydrogen gas inhalation on post-exercise oxidative stress markers, antioxidative capacity, peripheral vascular responses, and exercise performance in healthy adult female rowers. This study is not intended to provide confirmatory evidence of efficacy, but rather to generate hypotheses and assess feasibility for future randomized crossover trials.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recovery-phase change in dilution-corrected urinary 8-OH-dG. For each condition, the change from immediately post-exercise to 60 minutes post-exercise will be calculated, and the within-participant difference between the hydrogen inhalation condition and the placebo inhalation condition will be evaluated.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Placebo inhalation condition: Participants inhaled room air through the inhalation device for 30 minutes. They then completed one incremental exercise test using a Wattbike. Blood and urine sampling, ultrasound assessment of peripheral venous diameter, breath hydrogen measurement, and rating of perceived exertion using the Borg scale were performed at baseline, immediately post-exercise, and 60 minutes post-exercise. This condition was conducted on the same day and preceded the hydrogen inhalation condition.
Interventions/Control_2
Hydrogen inhalation condition: After the placebo inhalation condition and a 60-minute recovery interval, participants inhaled air containing approximately 4% hydrogen gas for 30 minutes using a hydrogen inhalation device. They then completed one incremental exercise test using a Wattbike. Blood and urine sampling, ultrasound assessment of peripheral venous diameter, breath hydrogen measurement, and rating of perceived exertion using the Borg scale were performed at pre-inhalation baseline, immediately post-exercise, and 60 minutes post-exercise. The hydrogen concentration was set below the lower explosive limit, and safety was managed with adequate ventilation and gas detector monitoring during testing.
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
Female
Key inclusion criteria
Healthy adult females aged 18 to 30 years
Rowers with national-level competitive experience
Participants who received oral and written explanations of the study aims, procedures, and potential risks and provided written informed consent
Participants able to complete incremental exercise testing using a Wattbike after hydrogen and placebo inhalation conditions
Key exclusion criteria
Individuals with cardiovascular, respiratory, neuromuscular, orthopedic, or injury-related conditions that may interfere with safe completion of exercise testing
Individuals with poor physical condition, fever, acute illness, or marked fatigue on the test day
Individuals who are pregnant or may be pregnant
Individuals judged by the principal investigator to be unsuitable for hydrogen inhalation or study procedures for safety reasons
Individuals otherwise judged by the principal investigator to be inappropriate for participation in the study
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Yuusuke |
| Middle name | |
| Last name | Harada |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
730-0053
Address
1-1-89 Higashi Senda-cho Nakaku Hiroshima City
TEL
082-542-7208
haradayu@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuusuke |
| Middle name | |
| Last name | Harada |
Organization
Hirishimauniversity
Division name
Graduate School of Humanities and Social Sciences
Zip code
730-0053
Address
1-1-89 Higashi Senda-cho Nakaku Hiroshima City
TEL
082-542-7208
Homepage URL
haradayu@hirishima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Self-funded by the investigators
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hosei University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hosei University Research and Development Center, Ichigaya Office
Address
Hosei University Research and Development Center, Shin-mitsuke Building 1F, 2-16 Ichigaya-tamachi, Shinjuku-ku, Tokyo 162-0843, Japan
Tel
03-5228-1244
suisin@adm.hosei.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 | 07 | 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
4
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
| 2023 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 08 | 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
| 2026 | Year | 07 | Month | 08 | Day |
Last modified on
| 2026 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071146
