臨床研究等提出・公開システム

Japanese

Date of registration	May. 22, 2018
Last modified on	May. 21, 2018
Trial ID	jRCT1090220347

Scientific Title	The effect of resistance training and protein supplementation programs on intramuscular adipose tissue in sarcopenic and dynapenic older adults. (Resistance training and protein supplementation programs)
Public Title	The effect of resistance training and protein supplementation programs on intramuscular adipose tissue in sarcopenic and dynapenic older adults.

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	RECRUITING

Date of First Enrollment		May. 14, 2018
Planned Number of Subjects		100
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
Key inclusion & exclusion criteria	Inclusion Criteria	Community-dwelling sarcoprnic and dynapenic 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)		Sarcopenic and dynapenic older adults
Intervention(s)		Intervention type:BEHAVIOUR Name of intervention:resistance training and protein intake,resistance training,protein intake Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE,NOT APPLICABLE,NOT APPLICABLE Route of administration / Site of application:NOT APPLICABLE,NOT APPLICABLE,NOT APPLICABLE Dose per administration:None,None,None None,None,None None,None,None Dosing frequency / Frequency of use:QD,QD,QD None,None,None Planned duration of intervention:3 months,3 months,3 months Intended dose regimen:None,None,None detailes of teratment arms:None,None,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 month Intended dose regimen:None
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Intramuscular adipose tissue
Secondary Outcome(s)		Muscle strength

Primary Sponsor	Minoru Yamada
Secondary Sponsor

Sources of funding	own fund

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

Date of approved	Feb. 06, 2018

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Secondary Study ID	Nill Known
Issuer Name

Secondary Study ID	JMA-IIA00347
Issuer Name

Countrie(s) of Recruitment	Japan