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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036863
Receipt No. R000041938
Scientific Title Physical characteristics of high school soccer players with groin pain and effect of prevention program.
Date of disclosure of the study information 2019/05/30
Last modified on 2019/05/27

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Basic information
Public title Physical characteristics of high school soccer players with groin pain and effect of prevention program.
Acronym Physical characteristics of high school soccer players with groin pain and effect of prevention program.
Scientific Title Physical characteristics of high school soccer players with groin pain and effect of prevention program.
Scientific Title:Acronym Physical characteristics of high school soccer players with groin pain and effect of prevention program.
Region
Japan

Condition
Condition healthy individuals
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the preventive effect of high school football players by performing Copenhagen Adduction Exercise and Nordic Hamstrings Exercise.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Injury rate of adductor muscle and hamstrings
training hour time per week
Match hour time per week
Weekly injury occurred
Hour time missed training due to injury per week
Hour time the game was canceled due to injury per week
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Copenhagen adduction exercise for 5 minute a day will be performed for 2 times a week in 20 weeks.
Interventions/Control_2 Copenhagen adduction exercise and Nordic hamstrings execise for 8 minute a day will be performed for 2-3 times a week in 20 weeks.
Interventions/Control_3 A control group performs the usual practice.
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 1,Male high school soccer player.
2,The player who does not have any treatment during this study.
Key exclusion criteria 1,The player who couldn't get consent of participation in this study.
Target sample size 240

Research contact person
Name of lead principal investigator
1st name Kiyokazu
Middle name
Last name Akasaka
Organization Medical Science, Graduate School of Medicine, Saitama Medical University
Division name Department of Physical Therapy
Zip code 350-0496
Address 981 Kawakado Moroyamamachi Irumagun, Saitama
TEL 049-295-8246
Email akasaka-msc@umin.ac.jp

Public contact
Name of contact person
1st name Kazuki
Middle name
Last name Fujisaki
Organization Medical Science, Graduate School of Medicine, Saitama Medical University
Division name Department of Physical Therapy
Zip code 350-0496
Address 981 Kawakado Moroyamamachi Irumagun, Saitama
TEL 049-295-8246
Homepage URL
Email kazuki.0838@gmail.com

Sponsor
Institute Department of Physical Therapy, Medic
al Science, Graduate School of Medicine, Saitama Medical University
Institute
Department

Funding Source
Organization Department of Physical Therapy, Medic
al Science, Graduate School of Medicine, Saitama Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Medical Science, Graduate School of Medicine, Saitama Medical University
Address 981 Kawakado Moroyamamachi Irumagun, Saitama
Tel 049-295-8246
Email kazuki.0838@gmail.com

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
2019 Year 05 Month 30 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 20 Day
Last follow-up date
2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 27 Day
Last modified on
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041938

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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