UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051881 |
|---|---|
| Receipt number | R000059194 |
| Scientific Title | Influence of wearing bio gear clothing on muscle temperature and NK cell activity following acute exercise |
| Date of disclosure of the study information | 2023/08/10 |
| Last modified on | 2023/08/10 10:04:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Influence of wearing bio gear clothing on muscle temperature and NK cell activity following acute exercise
Acronym
Influence of wearing bio gear clothing on muscle temperature and NK cell activity following acute exercise
Scientific Title
Influence of wearing bio gear clothing on muscle temperature and NK cell activity following acute exercise
Scientific Title:Acronym
Influence of wearing bio gear clothing on muscle temperature and NK cell activity following acute exercise
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Revealing the impact of wearing bio gear garments on the maintenance of immune function through sustaining muscle temperature following acute high-intensity exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Measuring NK cell activity within 3 hours post-exercise to evaluate immune function
Key secondary outcomes
Measuring deep muscle temperature within 3 hours post-exercise to evaluate insulation effect
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Wearing insulated tights after high-intensity exercise (resistance training and high-intensity interval exercise), followed by a distinct interval and wearing non-insulated tights after high-intensity exercise.
Interventions/Control_2
Wearing non-insulated tights after high-intensity exercise (resistance training and high-intensity interval exercise), followed by a distinct interval and wearing insulated tights after high-intensity exercise.
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Males aged 40 or younger
2. Individuals with a habit of physical activity (engaging in exercise of moderate intensity or higher, such as walking for at least 30 minutes, at least once a week in the past 3 months)
Key exclusion criteria
1. Individuals with chronic conditions who are regularly undergoing medication treatments (steroidal medications, alpha-blockers, beta-blockers, and drugs affecting heart rate).
2. Individuals for whom exercise is prohibited.
3. Individuals with arrhythmias.
4. Other individuals deemed inappropriate by physicians and the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshinari |
| Middle name | |
| Last name | Uehara |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
8140104
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL
+819087558973
yamatai0605@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Yamamoto |
Organization
Fukuoka univercity
Division name
Faculty of Sports and Health Science
Zip code
8140104
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL
+819087558973
Homepage URL
tyamamoto@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Mizuno Corporation
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
Fukuoka University
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
Tel
+819087558973
tyamamoto@fukuoka-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
| 2023 | Year | 08 | Month | 10 | 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
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 10 | Day |
Last modified on
| 2023 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059194
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
