UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042034 |
|---|---|
| Receipt number | R000047574 |
| Scientific Title | About preventive measures against covid-19 infection in sports |
| Date of disclosure of the study information | 2020/10/07 |
| Last modified on | 2024/07/11 16:39:10 |
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Basic information
Public title
About preventive measures against covid-19 infection in sports
Acronym
For covid-19 infection prevention measures in sport
Scientific Title
About preventive measures against covid-19 infection in sports
Scientific Title:Acronym
For covid-19 infection prevention measures in sport
Region
| Japan |
Condition
Condition
Healthy general population
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare and evaluate the effects of various American football shields against splash infections of covid-19 on body temperature and heat environment factors from the viewpoint of heat stroke prevention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
During exercise test
1) Physiological change
2) Heat environmental change
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The exercise test is performed by wearing American football helmets under four types of shield conditions.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) The participant who can wear American football helmets.
2) Those who can exercise with a bicycle ergo-meter.
3) Those that consent form by the free will of the person was provided after enough understanding after having received explanation on participation of this study.
Key exclusion criteria
1) The participant who have difficulty in continuing measurement due to the progression of some kinds of diseases.
2) Those who are judged by the doctors to stop the measurement.
3) Those who were judged unsuitable as a participant by the doctors.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Fujiya |
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, JAPAN
TEL
044-977-8111
fujiya-1487@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Muroi |
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, JAPAN
TEL
044-977-8111
Homepage URL
ryota.muroi@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Sports Medicine,
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School & Research Promotion Division, St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, JAPAN
Tel
044-977-8111
k-shienbu.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
| 2020 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1
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
| 2020 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2024 | 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
| 2020 | Year | 10 | Month | 07 | Day |
Last modified on
| 2024 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047574
