UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056474 |
|---|---|
| Receipt number | R000064531 |
| Scientific Title | Effects of contrast bathing, which combines sauna and cold-water bathing, on arterial stiffness: a crossover randomized controlled trial |
| Date of disclosure of the study information | 2024/12/17 |
| Last modified on | 2024/12/17 12:41:33 |
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Basic information
Public title
The effect of sauna bathing methods on blood vessel health: A study to investigate
Acronym
Sauna and Vascular Health Study
Scientific Title
Effects of contrast bathing, which combines sauna and cold-water bathing, on arterial stiffness: a crossover randomized controlled trial
Scientific Title:Acronym
Sauna and arterial stiffness Study
Region
| Japan |
Condition
Condition
Healthy Volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of a bathing method combining sauna bathing and cold water immersion (contrast bathing) on arterial stiffness, a predictive marker of cardiovascular disease, using a randomized crossover trial.
Basic objectives2
Others
Basic objectives -Others
To investigate the effects of sauna bathing methods on the cardiovascular system.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brachial-ankle pulse wave velocity will be measured before bathing, immediately after bathing, and 30 minutes after bathing.
Key secondary outcomes
Pulse late and blood pressure will be measured before bathing, immediately after bathing, and 30 minutes after bathing.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Participants will undergo 10 minutes of sauna bathing, followed by 1 minute of cold-water immersion and 5 minutes of outdoor cooling, repeated as a set. This procedure will be performed for a total of 3 sets. Control: Participants will undergo 10 minutes of sauna bathing, followed by 1 minute of showering and 5 minutes of outdoor cooling, repeated as a set. This procedure will also be performed for a total of 3 sets. The temperature settings for each session are as follows: sauna bathing at 86 degrees Celsius, and cold-water immersion at 17 degrees Celsius.
Interventions/Control_2
Participants will undergo 10 minutes of sauna bathing, followed by 1 minute of showering and 5 minutes of outdoor cooling, repeated as a set. This procedure will also be performed for a total of 3 sets. The temperature settings for each session are as follows: sauna bathing at 86 degrees Celsius, and showering at 40 degrees Celsius.
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
| 20 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Male individuals aged 20-22.
2) Persons who can fully understand the purpose and sign the consent form.
3) Persons who can comply with the intervention.
Key exclusion criteria
1) Individuals with abnormalities detected during health screening.
2) Those with severe skin conditions or allergies to cold-water baths.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hiroya |
| Middle name | |
| Last name | Koshiba |
Organization
Osaka University of Health and Sport Sciences
Division name
Graduate School of Sport and Exercise Sciences
Zip code
590-0496
Address
1-1 Asashirodai, Kumatori-cho, Sennan-gun, Osaka
TEL
072-479-3121
hiroyakoshiba@gmail.com
Public contact
Name of contact person
| 1st name | Hiroya |
| Middle name | |
| Last name | Koshiba |
Organization
Osaka University of Health and Sport Sciences
Division name
Graduate School of Sport and Exercise Sciences
Zip code
590-0496
Address
1-1 Asashirodai, Kumatori-cho, Sennan-gun, Osaka
TEL
072-479-3121
Homepage URL
hiroyakoshiba@gmail.com
Sponsor or person
Institute
Osaka University of Health and Sport Sciences
Institute
Department
Personal name
Funding Source
Organization
Osaka University of Health and Sport Sciences
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University of Health and Sport Sciences
Address
1-1 Asashirodai, Kumatori-cho, Sennan-gun, Osaka
Tel
072-453-7022
kenkyu@ouhs.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
| 2024 | Year | 12 | Month | 17 | 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
11
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 | 11 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 17 | Day |
Last modified on
| 2024 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064531
