UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046781 |
|---|---|
| Receipt number | R000053310 |
| Scientific Title | Season,circadian rhythe of the exercise inntensity threshold judging from the change of the thrombogenesis-related factor. |
| Date of disclosure of the study information | 2022/01/30 |
| Last modified on | 2022/01/30 17:59:20 |
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Basic information
Public title
Season,circadian rhythe of the exercise inntensity threshold judging from the change of the thrombogenesis-related factor.
Acronym
Season,circadian rhythe of the exercise inntensity threshold judging from the change of the thrombogenesis-related factor.
Scientific Title
Season,circadian rhythe of the exercise inntensity threshold judging from the change of the thrombogenesis-related factor.
Scientific Title:Acronym
Season,circadian rhythe of the exercise inntensity threshold judging from the change of the thrombogenesis-related factor.
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine effect to give to intenensity (exercise intensity threshold) to develop the thrombotic tendency which we observed from a thrombogensis-related factor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate that is running
Thrombogensis-related factor before and after the running(Platelet,von Willebrand factor,ADAMTS13)
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Low intensive running (4 times)
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
1)The person that an agreement by the free willwas obtain.
2)The person who is boys university students 20 year or older.
3)Person with exercise habits it or more three times a week.
Key exclusion criteria
The person who judged that a study person in charge was inappropriate.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hiromichi |
| Middle name | |
| Last name | Ishizashi |
Organization
Nara Medical University
Division name
Department of Health and Sports Science
Zip code
634-8521
Address
840 Shijyo-cyo,Kashihara City Nara
TEL
0744-22-3051
hishiza@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromichi |
| Middle name | |
| Last name | Ishizashi |
Organization
Nara Medical University
Division name
Department of Health and Sports Science
Zip code
634-8521
Address
840 Shijyo-cyo,Kashihara City Nara
TEL
0744-22-3051
Homepage URL
hishiza@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Department of Health and Sports Science
Institute
Department
Personal name
Funding Source
Organization
Grand-in-Aid for Scientific Reseach
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
Nara Medical University Ethics Committee
Address
840 Shijyo-cyo,Kashihara City Nara
Tel
0744-22-3051
ino_rinri@naramed-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
| 2022 | Year | 01 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 30 | Day |
Last modified on
| 2022 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053310
