UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026870 |
|---|---|
| Receipt number | 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 14:59:49 |
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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
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
doc27022@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030833
