UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036748
Receipt number R000041875
Scientific Title Observational study of sport experience and sport injury in university students
Date of disclosure of the study information 2019/05/16
Last modified on 2020/11/10 11:06:12

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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 or person

Institute

Faculty of Education, Mie University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041875


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name