UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the risk factors causing lower-extremity overuse injury in cadets of the Self Defense Forces
Title of the study (Brief title)	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	Masatoshi Amako
Organization	National Defense Medical College
Division name	Department of Orthopaedic Surgery
Address	3-2 Namiki, Tokorozawa, Saitama, Japan
TEL	042-995-1663
Email	doc27022@ndmc.ac.jp

Public contact
Name of contact person	Hiroshi Sasao
Organization	National Defense Medical College
Division name	Department of Orthpaedic Surgery
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 03 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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