UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050473 |
|---|---|
| Receipt number | R000057408 |
| Scientific Title | Effects of Hyperbaric Oxygen Therapy on Oxidative Stress after High-intensity Exercise. |
| Date of disclosure of the study information | 2023/03/02 |
| Last modified on | 2024/11/12 14:13:18 |
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Basic information
Public title
Effects of Hyperbaric Oxygen Therapy on Oxidative Stress after High-intensity Exercise.
Acronym
Effects of Hyperbaric Oxygen Therapy on Oxidative Stress after High-intensity Exercise.
Scientific Title
Effects of Hyperbaric Oxygen Therapy on Oxidative Stress after High-intensity Exercise.
Scientific Title:Acronym
Effects of Hyperbaric Oxygen Therapy on Oxidative Stress after High-intensity Exercise.
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effects of hyperbaric oxygen therapy on oxidative stress after high-intensity exercise.
Basic objectives2
Others
Basic objectives -Others
Subjects will undergo an exercise test using a bicycle for 60 minutes at 75-80% intensity of maximal oxygen uptake (VO2max). Exhaled gas parameters and heart rate will be measured over time during exercise. Subjective exercise intensity will also be recorded at regular intervals during exercise. In addition, blood and urine samples will be collected before and after exercise. These biological samples will be used to measure inflammation, oxidative stress and biochemical test indices. There will also be 10 interventions of hyperbaric oxygen therapy, before and after which the extent of changes in sleep improvement, pain relief and autonomic nervous system regulation will be assessed.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
maximal oxygen uptake (VO2max)
Key secondary outcomes
oxidative stress indexes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Subjects will receive 10 sessions of hyperbaric oxygen therapy for one month.
Interventions/Control_2
Subjects will not receive hyperbaric oxygen therapy for one month.
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
healthy individuals aged 18-30
Key exclusion criteria
Abnormal findings on resting 12-lead electrocardiogram and/or blood pressure, Cannot limit drinking the day before the experiment, Smoking or taking antioxidant supplements, Taking anti-allergy agent or anti-inflammatory agent
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Suzuki |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa
TEL
+81429476898
katsu.suzu@waseda.jp
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Suzuki |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa
TEL
+81429476898
Homepage URL
katsu.suzu@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Katsuhiko Suzuki
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office of Research Ethics, Waseda University
Address
1-104 Totsuka-cyo, Shinjyuku-ku, Tokyo
Tel
0352721639
rinri@list.waseda.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
早稲田大学/Waseda University（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 02 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 01 | 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 | 03 | Month | 02 | Day |
Last modified on
| 2024 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057408
