UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058957 |
|---|---|
| Receipt number | R000067426 |
| Scientific Title | The Effects of the Environment on the Body during the Recovery Period after High-Intensity Interval Exercise in Young Healthy Adult Males |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/09/01 20:55:59 |
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Basic information
Public title
The Effects of the Environment on the Body during the Recovery Period after High-Intensity Interval Exercise in Young Healthy Adult Males
Acronym
The Effects of the Environment on the Body during the Recovery Period after High-Intensity Interval Exercise in Young Healthy Adult Males
Scientific Title
The Effects of the Environment on the Body during the Recovery Period after High-Intensity Interval Exercise in Young Healthy Adult Males
Scientific Title:Acronym
The Effects of the Environment on the Body during the Recovery Period after High-Intensity Interval Exercise in Young Healthy Adult Males
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of the recovery phase environment on cardiac parasympathetic nervous system activity following underwater high-intensity interval exercise (HIIE).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiac parasympathetic nervous system activity during recovery phase
Key secondary outcomes
Heart Rate, Blood Pressure, RPE, oxygen uptake
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
High-intensity interval exercise and recovery on land (L-L) condition
Interventions/Control_2
High-intensity interval exercise and recovery in water (L-W) condition
Interventions/Control_3
High-intensity interval exercise in water and recovery on land (W-L) condition
Interventions/Control_4
High-intensity interval exercise in water and recovery in water (W-W) condition
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
Key inclusion criteria
Healthy university males without exercise habits
Key exclusion criteria
1. Persons with cardiovascular disease indicated in a physical examination
2. Persons who have difficulty performing the pedaling exercises in this study due to locomotor disease in the lower extremities
3. Smokers
4. Persons who have allergic reactions to zinc (synthetic acrylic fiber) and alcohol
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | ONO |
Organization
Kobe university
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo, JAPAN
TEL
0787922555
onoku@tiger.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | ONO |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
6540142
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo, JAPAN
TEL
078-792-2555
Homepage URL
onoku@tiger.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Health Sciences, Health Sciences Ethics Committee
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo, JAPAN
Tel
0787964502
syomu2@ams.kobe-u.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 | 09 | Month | 01 | 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
| 2025 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 10 | 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 | 09 | Month | 01 | Day |
Last modified on
| 2025 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067426
