UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the relationship between walking characteristics and body composition
Acronym	A Study on the relationship between walking characteristics and body composition
Scientific Title	A Study on the relationship between walking characteristics and body composition
Scientific Title:Acronym	A Study on the relationship between walking characteristics and body composition
Region	Japan

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

Objectives
Narrative objectives1	To study on the relationship between gait and physical composition and function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Gait Analysis 2.Body Composition
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	20 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	-Healthy person -A person which is not Tough to walk
Key exclusion criteria	-A person with the pain which has influence on a walk -A person which performed an operation in the past and where a walk is usually more difficult -A person which has resistance in equipping with a accelerometer -A person where a pacemaker and sorted metals (a stent and a clip) are contained in the inside of the body -A person which has a skin disorder in an abdomen or allergy to metal. -A person under pregnancy and with the possibility of pregnancy
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshifumi Niki
Organization	Kao Corporation
Division name	R&D-Personal Health Care Products Research
Zip code
Address	2-1-3, Bunka, Sumida-ku, Tokyo, JAPAN
TEL	03-5630-9848
Email	niki.yoshifumi@kao.co.jp

Public contact
Name of contact person	1st name Middle name Last name Naoto Takayanagi
Organization	Kao Corporation
Division name	R&D-Personal Health Care Products Research
Zip code
Address	2-1-3, Bunka, Sumida-ku, Tokyo, JAPAN
TEL	03-5630-7486
Homepage URL
Email	takayanagi.naoto@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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	花王株式会社 すみだ事業場（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 28 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	Completed
Date of protocol fixation	2016 Year 04 Month 11 Day
Date of IRB	2016 Year 04 Month 11 Day
Anticipated trial start date	2016 Year 04 Month 29 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Researchers recruit in-house volunteers

Management information
Registered date	2016 Year 04 Month 11 Day
Last modified on	2020 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025207