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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017965
Receipt No. R000018269
Scientific Title The association between exercise training and immune response
Date of disclosure of the study information 2015/06/19
Last modified on 2017/06/19

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Basic information
Public title The association between exercise training and immune response
Acronym The association between exercise training and immune response
Scientific Title The association between exercise training and immune response
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroyuki Daida
Organization Juntendo University School of Medicine
Division name Department of Cardiology
Zip code
Address 2-1-1 Hongo Bunkyo-ku, Tokyo Japan
TEL 03-3813-3111
Email daida@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Shimada
Organization Juntendo University School of Medicine
Division name Department of Cardiology
Zip code
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)

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
2015 Year 06 Month 19 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 Completed
Date of protocol fixation
2014 Year 10 Month 17 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000018269

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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