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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026870
Receipt No. R000030833
Scientific Title Investigation of the risk factors causing lower-extremity overuse injury in cadets of the Self Defense Forces
Date of disclosure of the study information 2017/04/05
Last modified on 2018/12/26

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Basic information
Public title Investigation of the risk factors causing lower-extremity overuse injury in cadets of the Self Defense Forces
Acronym Investigation of the risk factors causing lower-extremity overuse injury in cadets of the Self Defense Forces
Scientific Title Investigation of the risk factors causing lower-extremity overuse injury in cadets of the Self Defense Forces
Scientific Title:Acronym Investigation of the risk factors causing lower-extremity overuse injury in cadets of the Self Defense Forces
Region
Japan

Condition
Condition lower extremity overuse injury
stress fracture
Classification by specialty
Orthopedics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the risk factors of lower extremity overuse injury.
Basic objectives2 Others
Basic objectives -Others Lower extremity overuse injuries are common in physically-active populations. For example, athletes and military recruits.This study is aimed to verify the relationship between bone mass change accompanying exercise and stress fracture which is thought ti be caused by it, and to formulate preventive method.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Occurrence of lower extremity overuse injury
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
17 years-old <=
Age-upper limit
20 years-old >=
Gender Male and Female
Key inclusion criteria Freshman of the college of the Self Defense Forces.
Key exclusion criteria None
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Amako
Organization National Defense Medical College
Division name Department of Orthopaedic Surgery
Zip code
Address 3-2 Namiki, Tokorozawa, Saitama, Japan
TEL 042-995-1663
Email doc27022@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Sasao
Organization National Defense Medical College
Division name Department of Orthpaedic Surgery
Zip code
Address 3-2 Namiki, Tokorozawa, Saitama, Japan
TEL 042-995-1663
Homepage URL
Email doc27022@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

Funding Source
Organization Department of Orthpaedic Surgery, National Defense Medical College
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
Address
Tel
Email

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
2017 Year 04 Month 05 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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Following items will be observed.
1.Clinical:diagnosis, location, treatmentand outcome of the stress fracture
2.Questionnaire:age, sex, blood type, height, body weight, sports-activity, result of physical test and past history
3.bone mass(QUS)

Management information
Registered date
2017 Year 04 Month 05 Day
Last modified on
2018 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030833

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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