UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035617 |
|---|---|
| Receipt number | R000040575 |
| Scientific Title | Clinical investigation for the early effects of physical exercise on concentrations of aging-related biomarkers in circulation |
| Date of disclosure of the study information | 2019/01/23 |
| Last modified on | 2021/01/22 17:17:32 |
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Basic information
Public title
Clinical investigation for the early effects of physical exercise on concentrations of aging-related biomarkers in circulation
Acronym
Clinical investigation for the early effects of physical exercise on concentrations of aging-related biomarkers in circulation
Scientific Title
Clinical investigation for the early effects of physical exercise on concentrations of aging-related biomarkers in circulation
Scientific Title:Acronym
Clinical investigation for the early effects of physical exercise on concentrations of aging-related biomarkers in circulation
Region
| Japan |
Condition
Condition
normal individuals
Classification by specialty
| Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate early effect of exercise on human health status and circulating level of aging-related factors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluating percentage of participants of whom circulating ANGPTL2 level is decreased by exercise.
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
Stretching exercise, or walking exercise
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult individuals without daily habits of exercise.
Key exclusion criteria
<20 years old, severe diabetes, severe heart disease, severe lung disease, severe liver disease, severe kidney disease, severe peripheral artery disease, severe cancer, severe dementia, without routine medical check in 2017, or inappropriate by the judgment of the doctor.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Oike |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Molecular Genetics
Zip code
8608556
Address
1-1-1 Honjyo, Chuo-ku, Kumamoto, Kumamoto, Japan
TEL
096-373-5142
olegene@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Morinaga |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Molecular Genetics
Zip code
8608556
Address
1-1-1 Honjyo, Chuo-ku, Kumamoto, Kumamoto, Japan
TEL
096-373-5142
Homepage URL
morijun@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Saishunkan Co., Ltd.
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
Ethics Committee of Kumamoto University
Address
1-1-1, Honjo, Chuo-ku, Kumamoto City, japan
Tel
096-373-5657
ski-shien@jimu.kumamoto-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
| 2019 | Year | 01 | Month | 23 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
50
Results
No significant effect of physical exercise on aging-related biomarkers was observed.
Results date posted
| 2021 | Year | 01 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
General workers.
Participant flow
After study enrolment, participants performed exercise for one week.
Adverse events
No.
Outcome measures
Circulating levels of aging related biomarkers.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | 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
| 2019 | Year | 01 | Month | 22 | Day |
Last modified on
| 2021 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040575
