臨床研究等提出・公開システム

Scientific Title	Walking and nutritional supplementation programs to improve physical function in community-dwelling older adults (Walking and nutritional supplementation programs)
Public Title	Walking and nutritional supplementation programs to improve physical function in community-dwelling older adults

Contact for Scientific Queries	Investigator Name	Minoru Yamada
	Investigator Organization	Kyoto University Graduate school of Medicine
	Address	53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
	TEL	+81-75-751-3964
	E-mail	yamada@hs.med.kyoto-u.ac.jp
Contact for Public Queries	Contact Name	Minoru Yamada
	Contact Organization	Kyoto University Graduate school of Medicine
	Address	53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
	TEL	+81-75-751-3964
	E-mail	yamada@hs.med.kyoto-u.ac.jp

Recruitment Status	RECRUITING

Date of First Enrollment		June. 20, 2013
Planned Number of Subjects		440
Nature of Investigation		Interventional
Study Design	Description of Trial Design	cluster randomized controlled trial
	Type of Control
	Trial Blinding Schema	single blind
	Randomized	Yes
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Community-dwelling older adults aged 65 and older
	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)		improve physical function
Intervention(s)		Intervention type:BEHAVIOUR Name of intervention:Walking and nutritional supplementation programs 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:OTHER, SPECIFY none Planned duration of intervention:6 months Intended dose regimen:none detailes of teratment arms:none Comparative intervention name:Walking program 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:6 months Intended dose regimen:none
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		muscle mass
Secondary Outcome(s)		physical function

Primary Sponsor	Minoru YAMADA
Secondary Sponsor	Hidenori ARAI

Sources of funding	self-finance

Name of Ethics Committee
Address
TEL
FAX
E-Mail
Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	No
Reason for Unapproval

Date of approved

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Secondary Study ID	JMA-IIA00122
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	Oct. 02, 2013	(this page)	Changes
1	April. 01, 2013	Detail

List of change history