UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054503 |
|---|---|
| Receipt number | R000062266 |
| Scientific Title | The impacts of temperature and humidity changes on athletic performance |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/05/29 09:37:39 |
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Basic information
Public title
The impacts of temperature and humidity changes on athletic performance
Acronym
Temperature and humidity changes and athletic performance
Scientific Title
The impacts of temperature and humidity changes on athletic performance
Scientific Title:Acronym
Temperature and humidity changes and athletic performance
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the risk of exercise in a hot environment, we will evaluate the effect of changes in Wet Bulb Globe Temperature, an objective index obtained from temperature and humidity, on exercise performance.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core body temperature
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
By adjusting the room temperature and humidity, the WBGT is adjusted to 13-15 and 20-22, and a 20-minute exercise stress test is performed at each environment.
The stress intensity is set to 110% of the previously assessed anaerobic metabolic threshold.
Interventions/Control_2
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People who wished to participate in the study
Key exclusion criteria
People with cardiovascular diseases that require restrictions on exercise
People with musculoskeletal diseases that require restrictions on exercise
People with other diseases that require restrictions on exercise
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Ashikaga |
Organization
St. Marianna University School of Medicine
Division name
Department of Sports Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki city, Kanagawa prefecture
TEL
044-977-9327
k2ashikaga@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Ashikaga |
Organization
St. Marianna University School of Medicine
Division name
Department of Sports Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki city, Kanagawa prefecture
TEL
044-977-9327
Homepage URL
k2ashikaga@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Kohei Ashikaga
Funding Source
Organization
None
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
IRB, St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki city, Kanagawa prefecture
Tel
044-977-8111
k-sienbu.mail@marianna-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
| 2024 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 30 | 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 | 05 | Month | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062266
