UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041185 |
|---|---|
| Receipt number | R000046984 |
| Scientific Title | Study on the measurement method of oxidative stress-related factors as a blood indicator of exercise effect |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2023/02/24 11:05:40 |
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Basic information
Public title
Study on the measurement method of oxidative stress-related factors as a blood indicator of exercise effect
Acronym
Study on the measurement method of oxidative stress-related factors as a blood indicator of exercise effect
Scientific Title
Study on the measurement method of oxidative stress-related factors as a blood indicator of exercise effect
Scientific Title:Acronym
Study on the measurement method of oxidative stress-related factors as a blood indicator of exercise effect
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of the measurement method
Basic objectives2
Others
Basic objectives -Others
Analysis of the effects of exercise interventions
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurements of oxidative stress-related factors in blood samples obtained every 2 weeks from just before the intervention to week 8
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Exercise (30 minutes/day for light jogging or 45 minutes/day for walking, for light strength training using your own body weight 50 minutes/day) for 4 weeks. Blood samples will be taken every 2 weeks before the intervention and every 2 weeks until week 8, 4 weeks after the end of the intervention. Physical measurements and other tests will be performed before the intervention, immediately after the end of the intervention and 4 weeks after the end of the intervention.
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
Consenting adults
Key exclusion criteria
If consent is not obtained
Patients who are prohibited from exercising
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Keiki |
| Middle name | |
| Last name | Ogino |
Organization
Kochi university
Division name
Environmental Medicine
Zip code
783-8505
Address
Kohasu,Oko-cho,Nankoku-shi,Kochi 783-8505, JAPAN
TEL
088-880-2407
kogino@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiki |
| Middle name | |
| Last name | Ogino |
Organization
Kochi university
Division name
Environmental Medicine
Zip code
783-8505
Address
Kohasu,Oko-cho,Nankoku-shi,Kochi 783-8505, JAPAN
TEL
088-880-2407
Homepage URL
kogino@kochi-u.ac.jp
Sponsor or person
Institute
kochi University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
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
kochi Medical School
Address
Kohasu,Oko-cho,Nankoku-shi,Kochi 783-8505, JAPAN
Tel
088-880-2407
kogino@kochi-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
| 2021 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://krinri.cc.kochi-u.ac.jp/plan_ethical/app_form.php?id=ERB-108444
Publication of results
Unpublished
Result
URL related to results and publications
Information other than what is contained on this website is not available to the public at this time
Number of participants that the trial has enrolled
12
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The affiliation of the researcher who was to analyze, interpret, and summarize the study samples has changed. In addition, there was a period of significant travel restrictions due to the spread of COVID-19, which further delayed the entire process.
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 03 | 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 | 07 | Month | 21 | Day |
Last modified on
| 2023 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046984
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/03/21 | 計画書app_form.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/03/21 | 質問紙.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/03/21 | Excercise PCR for SOD2 mtDNA.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/46984
