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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039300
Receipt No. R000044824
Scientific Title A study about the prevention of the sports injury in the high school soccer players
Date of disclosure of the study information 2020/01/29
Last modified on 2020/01/29

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Basic information
Public title A study about the prevention of the sports injury in the high school soccer players
Acronym A study about the prevention of the sports injury in the high school soccer players
Scientific Title A study about the prevention of the sports injury in the high school soccer players
Scientific Title:Acronym A study about the prevention of the sports injury in the high school soccer players
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 youth soccer players
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes prevalence rate of sports related injury during nine months after intervention of the 12 weeks
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 medical check and exercise guidance by the physical therapist
static stretch exercise in three times a week
Interventions/Control_2 no intervention
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
15 years-old <=
Age-upper limit
18 years-old >=
Gender Male
Key inclusion criteria High school soccer players who agreed to join this study.
Key exclusion criteria Those who can not do exercise which be provided in this study.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Nobuhide
Middle name
Last name Azuma
Organization Fukui Health Science University
Division name Faculty of Health Science Department of Rehabilitation Physical Therapy
Zip code 910-3190
Address 55 Egami-cho 13-1, Fukui-City, Fukui
TEL 0776-59-2200
Email n-azuma.reha-pt@kir.biglobe.ne.jp

Public contact
Name of contact person
1st name Nobuhide
Middle name
Last name Azuma
Organization Fukui Health Science University
Division name Faculty of Health Science Department of Rehabilitation Physical Therapy
Zip code 910-3190
Address 55 Egami-cho 13-1, Fukui-City, Fukui
TEL 0776-59-2200
Homepage URL
Email n-azuma.reha-pt@kir.biglobe.ne.jp

Sponsor
Institute Fukui Health Science University
Institute
Department

Funding Source
Organization Fukui Health Science 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 Fukui General Hospital
Address 58 Egami-cho 16-1, Fukui-City, Fukui
Tel 0776-59-1300
Email fgh-hisyo@mopera.net

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 29 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 165
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 06 Month 26 Day
Date of IRB
2017 Year 06 Month 26 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2019 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 29 Day
Last modified on
2020 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044824

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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