UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042036 |
|---|---|
| Receipt number | R000047974 |
| Scientific Title | Epigenetic effects of interval walking training in middle-aged and older people |
| Date of disclosure of the study information | 2020/10/08 |
| Last modified on | 2020/10/07 11:30:37 |
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Basic information
Public title
Effects of exercise training on gene expression in middle aged and older people
Acronym
Effects of exercise on gene expression
Scientific Title
Epigenetic effects of interval walking training in middle-aged and older people
Scientific Title:Acronym
Epigenetic effects of interval walking training
Region
| Japan |
Condition
Condition
Life style related diseases
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To study the effects of interval walking training on pro-iflammatory genes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Methylation of target pro-iflammatory genes
Key secondary outcomes
Genetic substance, Exercise achievement, Exercise adherence, Life style related disease symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise training
Interventions/Control_2
Non-exercise training
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who had participated, participate, or will participate in the "Jukunentaiikudaigaku" project and who gave or will give us their blood samples for gene analyses.
2) Those who agreed or will agree that their blood samples are used to examine the effects of exercise training on pro-inflammatory gene expression.
3) Those who gave or will give us their informed consent to agree to the above stated examination.
Key exclusion criteria
1) Those who did not or do not agree to the above sated examination.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Shizue |
| Middle name | |
| Last name | Masuki |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano Prefecture
TEL
0263-37-2682
masuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shizue |
| Middle name | |
| Last name | Masuki |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matumoto, Nagano Prefecture
TEL
0263-37-2682
Homepage URL
masuki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
MECSST
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
Shinshu University
Address
3-1-1 Asahi, Matumoto, Nagano Prefecture
Tel
0263-37-2572
mdrinri@shinshu-u.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
| 2020 | Year | 10 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2020 | Year | 10 | Month | 07 | Day |
Last modified on
| 2020 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047974
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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