UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An observational study of physical capacity and muscular function in healthy Japanese.
Title of the study (Brief title)	An observational study of physical capacity and muscular function in healthy Japanese.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyze the age-related changes of physical capacity and muscular function in healthy Japanese
Basic objectives2	Others
Basic objectives -Others	Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Physical functions 2.Motor unit activity
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.A person who doesn't have a motor dysfunction. 2.A person who is able to participate in a functional fitness test. 3.A person who doesn't use a cardiac pacemaker and/or an artificial joint.
Key exclusion criteria	1.A person who had locomotive organ injury such as fracture,tendon rupture,muscle strain in the last 1 year. 2.A person who had been collected the blood more than 200 mL or 400 mL, within one month or three months before this study. 3.A person who is in bad condition 4.A person who are not eligible due to physician's judgment.
Target sample size	130

Research contact person
Name of lead principal investigator	Noriyasu Ota
Organization	Kao Corporation
Division name	Biological Science Laboratories
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7828
Email	ota.noriyasu@kao.co.jp

Public contact
Name of contact person	Satoko Soga
Organization	Kao Corporation
Division name	Biological Science Laboratories
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7828
Homepage URL
Email	soga.satoko@kao.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kyoto Gakuen University
Name of secondary funｄer(s)

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	学校法人京都学園大学（京都府）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 29 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 04 Month 30 Day
Date trial data considered complete	2017 Year 05 Month 31 Day
Date analysis concluded	2017 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Participants will be recruited randomly from physical fitness measurement day sponsored by Kyoto Gakuen University.

Management information
Registered date	2016 Year 06 Month 24 Day
Last modified on	2016 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026353