UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039300 |
|---|---|
| Receipt number | 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 09:55:49 |
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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
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
n-azuma.reha-pt@kir.biglobe.ne.jp
Sponsor or person
Institute
Fukui Health Science University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044824
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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