UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017965 |
|---|---|
| Receipt number | 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 12:18:43 |
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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
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
shimakaz@juntendo.ac.jp
Sponsor or person
Institute
Department of Cardiology, Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018269
