UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046099 |
|---|---|
| Receipt number | R000052626 |
| Scientific Title | Physiological impacts of a new texture for sports clothing |
| Date of disclosure of the study information | 2021/11/18 |
| Last modified on | 2024/11/19 09:20:29 |
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Basic information
Public title
Physiological impacts of a new texture for sports clothing
Acronym
Physiological impacts of a new texture for sports clothing
Scientific Title
Physiological impacts of a new texture for sports clothing
Scientific Title:Acronym
Physiological impacts of a new texture for sports clothing
Region
| Japan |
Condition
Condition
NA
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effects of a clothing with a new texture on thermoregulatory responses during exercise in a hot environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sweat rate, rectal temperature, skin temperature
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Exercise wearing a shirt made with a new texture
Interventions/Control_2
Exercise wearing a shirt made with polyester
Interventions/Control_3
Exercise wearing a shirt made with polyester and an ice-vest
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy and physically active men (age: 20-40).
Key exclusion criteria
1) Smoker, obese individuals
2) Individuals experienced any cardiovascular disease
3) Individuals with cardiac arrhythmia
4) Individuals with asthma
5) Individuals with gastrointestinal disease
6) Individuals with epilepsy
7) Individuals taking any medications drugs
8) Individuals who have been considered to exclude the participants based on a researcher
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tatsuro |
| Middle name | |
| Last name | Amano |
Organization
Niigata University
Division name
Faculty of Education
Zip code
950-2181
Address
8050, Igarashi 2, Nishi-ku, Niigata, Niigata
TEL
025-262-7161
amano@ed.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuro |
| Middle name | |
| Last name | Amano |
Organization
Niigata University
Division name
Faculty of Education
Zip code
950-2181
Address
8050, Igarashi 2, Nishi-ku, Niigata, Niigata
TEL
025-262-7161
Homepage URL
amano@ed.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Mizuno co., ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human ethical committee of Niigata University
Address
8050, Igarashi 2, Nishi-ku, Niigata, Niigata
Tel
025-227-2625
ethics@adm.niigata-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
新潟大学
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 18 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1002/hfm.21044
Publication of results
Partially published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/hfm.21044
Number of participants that the trial has enrolled
35
Results
The results showed that, regardless of how the clothing was worn (e.g., single layer or layered) or the exercise location (e.g., indoors or outdoors), the microclimate within the new clothing was moderately improved. However, the impact on thermoregulatory responses was limited (e.g., a reduction in localized skin temperature), with no apparent effect on key parameters such as core body temperature.
Results date posted
| 2024 | Year | 11 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
With the impact of global warming, opportunities to exercise in hot environments are increasing. Developing highly breathable clothing and verifying its effectiveness are crucial steps in preventing heat-related illnesses.
Participant flow
Participants were recruited through flyers and announcements and were assigned to experiments under various conditions (primarily three conditions).
Adverse events
None.
Outcome measures
Rectal temperature, skin temperature, sweat rate, heart rate, subjective measures, and clothing microclimate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 11 | 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
| 2021 | Year | 11 | Month | 17 | Day |
Last modified on
| 2024 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052626
