UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061823 |
|---|---|
| Receipt number | R000070747 |
| Scientific Title | The Effects of Different Lower-Leg Immersion Temperatures on the Recovery of Cardiac Parasympathetic Activity After High-Intensity Interval Exercise in Healthy Young Males: A Randomized Crossover Trial |
| Date of disclosure of the study information | 2026/07/31 |
| Last modified on | 2026/06/08 11:59:29 |
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Basic information
Public title
The Effects of Different Lower-Leg Immersion Temperatures on the Recovery of Cardiac Parasympathetic Activity After High-Intensity Interval Exercise in Healthy Young Males: A Randomized Crossover Trial
Acronym
Effects of different lower-leg immersion temperatures on the recovery of heart rate after exercise
Scientific Title
The Effects of Different Lower-Leg Immersion Temperatures on the Recovery of Cardiac Parasympathetic Activity After High-Intensity Interval Exercise in Healthy Young Males: A Randomized Crossover Trial
Scientific Title:Acronym
Effects of different lower-leg immersion temperatures on the recovery of heart rate after exercise
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of different lower-leg immersion temperatures on the recovery of cardiac parasympathetic activity after high-intensity interval exercise in healthy young adult males.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiac parasympathetic nervous activity after high-intensity interval exercise during recovery
Key secondary outcomes
Heart Rate, Blood Pressure, Rating of Perceived Exertion (RPE)
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
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
with cold water lower-leg immersion after High-intensity interval exercise
Interventions/Control_2
with approximately 30 degrees C water lower-leg immersion after High-intensity interval exercise
Interventions/Control_3
with warm water lower-leg immersion after High-intensity interval exercise
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
Key inclusion criteria
Healthy young adult male with no 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
10
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | ONO |
Organization
Kobe University
Division name
Graduate School of Medicine, Department 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 Medicine, Department 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 Medicine, Research Ethics Committee of Myodani area
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
| 2026 | Year | 07 | Month | 31 | 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 | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 | 06 | Month | 08 | Day |
Last modified on
| 2026 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070747
