UMIN-CTR Clinical Trial

Basic information
Public title	Study of prevention for sports injury in school
Acronym	Study of prevention for sports injury in school
Scientific Title	Study of prevention for sports injury in school
Scientific Title:Acronym	Study of prevention for sports injury in school
Region	Japan

Condition
Condition	sports related injury
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal how to prevent a sports related injury in adolescent student.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	prevalence rate of sports related injury during 1 year with intervention
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	static stretch exercise for improving balance ability twice a month
Interventions/Control_2	static stretch exercise for improving balance ability once a month
Interventions/Control_3	static stretch exercise for improving balance ability once two month
Interventions/Control_4	no intervention
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Elementary school, junior high school and high school students who agreed to join this study.
Key exclusion criteria	Those who can not do exercise which be provided in this study.
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Masaru Middle name Last name Kadowaki
Organization	Shimane University
Division name	Department of Orthopaedic surgetry
Zip code	693-8501
Address	89-1, ennya-cho, Izumo
TEL	0853-20-2242
Email	masaru11@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name Masaru Middle name Last name Kadowaki
Organization	Shimane University
Division name	Department of Orthopaedic surgetry
Zip code	693-8501
Address	89-1, ennya-cho, Izumo
TEL	0853-20-2242
Homepage URL
Email	masaru11@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

Funding Source
Organization	Shimane University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shimane University
Address	89-1, ennya-cho, Izumo
Tel	0853-20-2259
Email	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	2020 Year 01 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	240
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	Terminated
Date of protocol fixation	2017 Year 09 Month 15 Day
Date of IRB	2017 Year 10 Month 23 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 09 Day
Last modified on	2022 Year 07 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044595