UMIN-CTR Clinical Trial

Basic information
Public title	A study about the improvement in effect of movement by walking assist instruments (part 2)
Acronym	A study about the improvement in effect of movement by walking assist instruments (part 2)
Scientific Title	A study about the improvement in effect of movement by walking assist instruments (part 2)
Scientific Title:Acronym	A study about the improvement in effect of movement by walking assist instruments (part 2)
Region	Japan

Condition
Condition	Pre-Frailty
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To consider the effect on gait by using walking assist instruments
Basic objectives2	Others
Basic objectives -Others	To compare the effect on gait by the presence or absence of walking assist instruments.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the interventional of walking assist instruments about physical activity, gait function, body composition, cognitive function.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Participation in the walking lesson by using walking assist instruments once a week and walking using them for 10 minutes for six weeks. -> Wash out for two weeks. -> Walking for 10 minutes for six weeks.
Interventions/Control_2	Walking for 10 minutes for six weeks. -> Wash out for two weeks. -> Participation in the walking lesson by using walking assist instruments once a week and walking using them for 10 minutes for six weeks.
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	70 years-old <=
Age-upper limit	79 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects applied for one or two of the flail evaluation standards (all five questions) created by the National Center for Geriatrics and Gerontology.
Key exclusion criteria	-Subjects with difficult for walking. -Subjects deemed inappropriate to participate in this study by the principle investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Motoki Middle name Last name Sudo
Organization	Kao Corporation
Division name	R&D -Development Research- Personal Health Care Research
Zip code	131-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL	+81-3-5630-7486
Email	sudo.motoki@kao.com

Public contact
Name of contact person	1st name Tomoya Middle name Last name Ueda
Organization	Kao Corporation
Division name	R&D -Development Research- Personal Health Care Research
Zip code	131-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL	+81-3-5630-7486
Homepage URL
Email	ueda.tomoya@kao.com

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	Human Research Ethics Committee, Kao COrporation
Address	2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
Tel	+81-3-5630-9220
Email	uesaka.toshio@kao.com

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	まちの健康研究所「あ・し・た」（千葉県）

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 05 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	30
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	2018 Year 07 Month 23 Day
Date of IRB	2018 Year 07 Month 23 Day
Anticipated trial start date	2018 Year 09 Month 06 Day
Last follow-up date	2019 Year 10 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 02 Month 26 Day

Other
Other related information

Management information
Registered date	2018 Year 08 Month 24 Day
Last modified on	2020 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038646

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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