UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056135 |
|---|---|
| Receipt number | R000064122 |
| Scientific Title | Observational Study about Factors of Accidents in Marathons |
| Date of disclosure of the study information | 2024/11/25 |
| Last modified on | 2024/11/12 18:45:08 |
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Basic information
Public title
Observational Study about Factors of Accidents in Marathons
Acronym
Observational Study about Factors of Accidents in Marathons
Scientific Title
Observational Study about Factors of Accidents in Marathons
Scientific Title:Acronym
Observational Study about Factors of Accidents in Marathons
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the factors that contribute to the occurrence of accidents in marathons
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Whether or not an accident occurred during the marathon run
Key secondary outcomes
Data acquired from wearable device
First-aid record
Questionnaire(fatigue, etc.)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Males and females aged between 18 and 75
Key exclusion criteria
Subjects who judged as unsuitable for the study by the investigator
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
EZAKI GLICO Co., Ltd.
Division name
Wellness Innovation Business Division
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka, 555-8502, Japan
TEL
+81-6-6477-8793
kei.yui@glico.com
Public contact
Name of contact person
| 1st name | Soshi |
| Middle name | |
| Last name | Tokiwa |
Organization
EZAKI GLICO Co., Ltd.
Division name
Wellness Innovation Business Division
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka, 555-8502, Japan
TEL
+81-6-6477-8442
Homepage URL
soshi.tokiwa@glico.com
Sponsor or person
Institute
EZAKI GLICO Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
EZAKI GLICO Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Runner's Wellness, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Glico Group
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka 555-8502, Japan
Tel
+81-6-6477-8352
kazunori.nishi@glico.com
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 | 11 | 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
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
| 2024 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following hypothetical hypothesis will be used to examine the influencing factors:
The frequency of marathon accidents and running records may be related to beverage intake and daily life.
Management information
Registered date
| 2024 | Year | 11 | Month | 12 | Day |
Last modified on
| 2024 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064122
