UMIN-CTR Clinical Trial

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
Email	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
Email	morijun@kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040575