UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045561 |
|---|---|
| Receipt number | R000052013 |
| Scientific Title | Minimally invasive immune evaluation study of exercise effect based on immuno-receptor analysis |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2025/03/28 09:13:12 |
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Basic information
Public title
Minimally invasive immune evaluation study of exercise effect based on immuno-receptor analysis
Acronym
Immune evaluation study of exercise effect
Scientific Title
Minimally invasive immune evaluation study of exercise effect based on immuno-receptor analysis
Scientific Title:Acronym
Immune evaluation study of exercise effect
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to obtain immunological evaluation data on the health-improving effect of exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
TCR, BCR analysis/2w for 3 months
Lymphocyte ratio of NK cells/2w for 3 months
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
Exercise intervention: 2-5 days a week, once within 1 hour.
Exercise load: METs index 3-4, Borg scale 11-13
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy person
(2) Age 20 and over, 80 and under (at the time of registration)
(3) Those who can obtain written consent from the person to participate in the research
Key exclusion criteria
(1) Those who do not agree with this study.
(2) When permission cannot be obtained for the use of this research.
(3) Those who wish to become pregnant during pregnancy, lactation, and during the exercise intervention period (3 months)
(4) Those who are judged by the doctor in charge or the care manager to be unfavorable for this study
(5) Those who withdrew their consent during the research period
(6) Those who have difficulty in continuing due to various reasons such as serious illness or injury during the exercise intervention period (3 months)
(7) Those who cannot tolerate exercise loads
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kouetsu |
| Middle name | |
| Last name | Ogasawara |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer
Zip code
980-8575
Address
4-1Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-8579
immunobiology@grp.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kouetsu |
| Middle name | |
| Last name | Ogasawara |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer
Zip code
980-8575
Address
4-1Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-8579
Homepage URL
immunobiology@grp.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University
Address
4-1Seiryo-machi, Aoba-ku, Sendai, Japan
Tel
022-717-8579
immunobiology@grp.tohoku.ac.jp
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
| 2021 | Year | 10 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052013
