UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051869 |
|---|---|
| Receipt number | R000059159 |
| Scientific Title | Investigation of the Female Athlete Triad in Young Japanese Female Athletes and Their Association with Calf Circumference |
| Date of disclosure of the study information | 2023/08/09 |
| Last modified on | 2023/08/09 11:37:51 |
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Basic information
Public title
Investigation of the Female Athlete Triad in Young Japanese Female Athletes and Their Association with Calf Circumference
Acronym
Relationship between FAT Survey and Calf Circumference
Scientific Title
Investigation of the Female Athlete Triad in Young Japanese Female Athletes and Their Association with Calf Circumference
Scientific Title:Acronym
Relationship between FAT Survey and Calf Circumference
Region
| Japan |
Condition
Condition
Female Athlete Triad
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The survey of the Female Athlete Triad, a major health disorder of female athletes, among young female athletes in Shimane Prefecture, also clarifies the relationship between FAT and calf circumference.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of FAT
Key secondary outcomes
Association between FAT and calf circumference, association between FAT and comorbidities (anemia, depression, dysmenorrhea, 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
| 12 | years-old | <= |
Age-upper limit
| 34 | years-old | >= |
Gender
Female
Key inclusion criteria
Female junior high school, high school, or university student, or a female adult under 34 years of age, living in Shimane Prefecture.
A member of a club, club activities, or sports club, and must exercise on a regular basis.
The participant's parent or guardian has given written consent for her to participate in the study.
Key exclusion criteria
Treatment for a medical or orthopedic condition.
Taking drugs that cause bleeding (antiplatelets, anticoagulants).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Sugihara |
Organization
Shimane University
Division name
Matsue health service center
Zip code
690-8504
Address
1060 Nishikawatsu, Matsue city
TEL
0852326568
shinobutozuito@soc.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Sugihara |
Organization
Shimane University
Division name
Matsue health service center
Zip code
690-8504
Address
1060 Nishikawatsu, Matsue city
TEL
0852326568
Homepage URL
shinobutozuito@soc.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane university
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1 Enyacho, Izumo City, Shimane Prefecture
Tel
0853-20-2515
kenkyu@med.shimane-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 | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A survey of the Female Athlete Triad (FAT), a major health disorder of female athletes, among young female athletes in Shimane Prefecture, also clarifies the relationship between FAT and maximum leg circumference.
Management information
Registered date
| 2023 | Year | 08 | Month | 09 | Day |
Last modified on
| 2023 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059159
| Research Plan | |
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| 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 |
