臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 18, 2018
Last modified on	April. 13, 2019
Trial ID	jRCT1090220394

Scientific Title	The effect of pattern made exercise program delivered by algorithm in older adults (Pattern made exercise program delivered by algorithm)
Public Title	The effect of pattern made exercise program delivered by algorithm in older adults

Study end date
Performed Number of Subjects
Baseline Characteristics
Participant Flow
Safety Conclusions
Efficacy Conclusions
Discussion and Overall Conclusions
Posted Date
Date of First Publication
Results Links

Plan to Share IPD
Plan Description
Protocol Links

Contact for Scientific Queries	Investigator Name	Minoru Yamada
	Investigator Organization	University of Tsukuba
	Address	3-29-1 Otsuka, Bunkyo-ku, Tokyo 112-0012, Japan
	TEL	+81-3-3942-6863
	E-mail	m-yamada@human.tsukuba.ac.jp
Contact for Public Queries	Contact Name	Minoru Yamada
	Contact Organization	University of Tsukuba
	Address	3-29-1 Otsuka, Bunkyo-ku, Tokyo 112-0012, Japan
	TEL	+81-3-3942-6863
	E-mail	m-yamada@human.tsukuba.ac.jp

Recruitment Status	COMPLETED

Date of First Enrollment		Nov. 01, 2017
Planned Number of Subjects		300
Nature of Investigation		Interventional
Study Design	Description of Trial Design	randomized controlled trial
	Type of Control
	Trial Blinding Schema	single blind
	Randomized	Yes
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	aged 65 years and older with the ability to walk independently (including with a cane)
	Exclusion Criteria	cardiac disorder, pulmonary disorder, severe musculoskeletal disorder, stroke, parkinson's disease
	Minimum Age	65age old over
	Maximum Age	No limit
	Sex of Participants	Both
Trial Indication(s)		Community-dwelling older adults
Intervention(s)		Intervention type:BEHAVIOUR Name of intervention:Pattern made exercise program by algorithm Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE Route of administration / Site of application:NOT APPLICABLE Dose per administration:None None None Dosing frequency / Frequency of use:TIW None Planned duration of intervention:3 month Intended dose regimen:None detailes of teratment arms:None Comparative intervention name:Control Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE Route of administration / Site of application:NOT APPLICABLE Dose per administration:None None None Dosing frequency / Frequency of use: None Planned duration of intervention:3 months Intended dose regimen:None
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		walking ability
Secondary Outcome(s)		Muscle mass

Primary Sponsor	Minoru Yamada
Secondary Sponsor

Sources of funding	Ministry of Health, Labor, and Welfare

Name of Ethics Committee	Ethics Committee of Tsukuba University Graduate School of Comprehensive Human Sciences
Address
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FAX
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Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved	Sept. 15, 2017

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Secondary Study ID	Nill Known
Issuer Name

Secondary Study ID	JMA-IIA00394
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	April. 13, 2019	(this page)	Changes
1	Oct. 18, 2018	Detail

List of change history