UMIN-CTR Clinical Trial

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
Email	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
Email	hishiza@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University Department of Health and Sports Science
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053310