UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033097 |
|---|---|
| Receipt number | R000037743 |
| Scientific Title | Core temperature measurement during outdoor sports activities |
| Date of disclosure of the study information | 2018/06/25 |
| Last modified on | 2022/12/27 00:51:10 |
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Basic information
Public title
Core temperature measurement during outdoor sports activities
Acronym
Core temperature measurement during outdoor sports activities
Scientific Title
Core temperature measurement during outdoor sports activities
Scientific Title:Acronym
Core temperature measurement during outdoor sports activities
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate core temperature during sports activities including athletic club.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core 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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Ingestion of a telemetric temperature sensor
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 and Female
Key inclusion criteria
1) Aged over 18 yrs
2) University students who are habitually engaged in competitive sports
Key exclusion criteria
1) In any subject whose weight is less than eighty (80) pounds
2) In the presence of any known or suspected obstructive disease of the gastrointestinal tract, including but not limited to diverticulitis and inflammatory bowel disease.
3) In any subject with previous gastrointestinal surgery
4) In any subject having felinization of the esophagus
5) In any subject who might undergo NMR/MRI scanning during the period that the CorTemp is within the body.
6) In any subject with hypomotility disorders of the gastrointestinal tract, including but not limited to ileus.
7) In any subject having a cardiac pacemaker or other implanted electromedical device.
Target sample size
20
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
Niigata University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka International University
Name of secondary funder(s)
Osaka International University
IRB Contact (For public release)
Organization
Human ethical committee of Niigata University
Address
8050 Ninocho, Igarashi, Nishi-ku, 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，大阪国際大学もしくはその周辺運動施設（新潟県，大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 25 | 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
10
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
| 2018 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2018 | Year | 06 | Month | 22 | Day |
Last modified on
| 2022 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037743
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
