UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between sports performance and sports injury and physical ability
Title of the study (Brief title)	Relationship between sports performance and sports injury and physical ability
Region	Japan

Condition
Condition	sports injury
Classification by specialty	Medicine in general Orthopedics Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examine how individual factors such as cardiorespiratory function, muscular strength and sports behavior are related to sports performance and sports injury.
Basic objectives2	Others
Basic objectives -Others	nothing
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Competition record, best time, history of sports injury
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	After answering the questionnaire, exercise load test using ergometer is carried out and the maximum oxygen intake amount is measured. As physical skill evaluation, you will receive height, weight, body fat measurement, whole body muscle strength measurement etc. Sports motion that the subject usually performs is measured with a 3D motion analysis device using a floor reaction force gauge and a motion capture system, and sports motion and electromyogram recording of each muscle are recorded.
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	18 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	People who has no serious complication which is thought to be difficult to exercise, such as congenital heart disease or severe asthma.
Key exclusion criteria	Those who did not obtain consent who can not exercise by safety
Target sample size	100

Research contact person
Name of lead principal investigator	Hideo Matsumoto
Organization	Keio University
Division name	Institute for Integrated sports medicine, school of medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5269-9054
Email	m-hideo@keio.jp

Public contact
Name of contact person	Koichiro Azuma
Organization	Keio University
Division name	Institute for integrated sports medicine, school of medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5269-9054
Homepage URL
Email	azumakx@keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Institute for Integrated Sports Medicine , School of Medicine, Keio University
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 03 Month 08 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 03 Month 02 Day
Anticipated trial start date	2018 Year 04 Month 01 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

Management information
Registered date	2018 Year 03 Month 08 Day
Last modified on	2018 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036120