UMIN-CTR Clinical Trial

Basic information
Public title	Observational study of sport experience and sport injury in university students
Acronym	Observational study of sport experience and sport injury in university students
Scientific Title	Observational study of sport experience and sport injury in university students
Scientific Title:Acronym	Observational study of sport experience and sport injury in university students
Region	Japan

Condition
Condition	Injury (external wound, disability)
Classification by specialty	Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between sport experience and sport injury in university students
Basic objectives2	Others
Basic objectives -Others	To investigate the relationship between sport experience and sport injury in university students
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Sport experience, sport injury, and its relationship
Key secondary outcomes

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	Not applicable
Gender	Male and Female
Key inclusion criteria	University students who belong to an A department in a B university
Key exclusion criteria	None
Target sample size	830

Research contact person
Name of lead principal investigator	1st name Ryosuke Middle name Last name Shigematsu
Organization	Mie University
Division name	Faculty of Education
Zip code	5148507
Address	1577 Kurimamachiya, Tsu, Mie
TEL	+81-59-231-9294
Email	rshige@edu.mie-u.ac.jp

Public contact
Name of contact person	1st name Ryosuke Middle name Last name Shigematsu
Organization	Mie University
Division name	Faculty of Education
Zip code	5148507
Address	1577 Kurimamachiya, Tsu, Mie
TEL	+81-59-231-9294
Homepage URL
Email	rshige@edu.mie-u.ac.jp

Sponsor
Institute	Faculty of Education, Mie University
Institute
Department

Funding Source
Organization	Faculty of Education, Mie University
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Mie University
Address	1577 Kurimamachiya, Tsu, Mie
Tel	+81-59-231-9294
Email	rshige@edu.mie-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	三重大学教育学部

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 16 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	570
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	2017 Year 04 Month 01 Day
Date of IRB	2018 Year 03 Month 08 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 09 Month 30 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information	To clarify the relationship between sport experience and sport injury

Management information
Registered date	2019 Year 05 Month 15 Day
Last modified on	2020 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041875