UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The association between exercise training and immune response
Title of the study (Brief title)	The association between exercise training and immune response
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Medicine in general Cardiology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The association between exercise training and immune response
Basic objectives2	Others
Basic objectives -Others	Bio-kinetics
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of immune system and immune-associated markers during short- and middle-term exercise training
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Exercise training
Interventions/Control_2	Exercise training
Interventions/Control_3	Exercise training
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	20 years-old <=
Age-upper limit	39 years-old >
Gender	Male
Key inclusion criteria	Students who belong to soccer club or cycling club, Students or school staffs without regular exercise training
Key exclusion criteria	1) Seropositive subjects against HBV antigen, HCV antibody, HIV antibody, or HTLV-1 antibody 2) Subjects with severe chronic disease 3) Subjects with steroid treatment 4) Subjects under treatment for pollinosis 5) Subjects with previous history of high risk for exercise 6) Subjects who judged as ineligible by investigators
Target sample size	42

Research contact person
Name of lead principal investigator	Hiroyuki Daida
Organization	Juntendo University School of Medicine
Division name	Department of Cardiology
Address	2-1-1 Hongo Bunkyo-ku, Tokyo Japan
TEL	03-3813-3111
Email	daida@juntendo.ac.jp

Public contact
Name of contact person	Kazunori Shimada
Organization	Juntendo University School of Medicine
Division name	Department of Cardiology
Address	2-1-1 Hongo Bunkyo-ku, Tokyo Japan
TEL	03-3813-3111
Homepage URL
Email	shimakaz@juntendo.ac.jp

Sponsor
Institute	Department of Cardiology, Juntendo University School of Medicine
Institute
Department

Funding Source
Organization	Kirin Company, Limited
Organization
Division
Category of Funding Organization	Profit organization
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	2015 Year 06 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 17 Day
Anticipated trial start date	2014 Year 12 Month 10 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	2015 Year 06 Month 18 Day
Last modified on	2017 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018269