臨床研究等提出・公開システム

Japanese

Date of registration	Nov. 07, 2017
Last modified on	May. 21, 2020
Trial ID	jRCT1090220314

Scientific Title	PROMOTION OF PHYSICAL ACTIVITY OF AGED AND AGEING PEOPLE USING PERVASIVE GAMES (PROMOTION OF PHYSICAL ACTIVITY OF AGED AND AGEING PEOPLE USING PERVASIVE GAMES)
Public Title	PROMOTION OF PHYSICAL ACTIVITY OF AGED AND AGEING PEOPLE USING PERVASIVE GAMES

Study end date
Performed Number of Subjects	50
Baseline Characteristics
Participant Flow
Safety Conclusions
Efficacy Conclusions
Discussion and Overall Conclusions
Posted Date
Date of First Publication
Results Links	JMIR Serious games

Plan to Share IPD
Plan Description
Protocol Links

Contact for Scientific Queries	Investigator Name	Kazuya Okamoto
	Investigator Organization	Kyoto University Hospital
	Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 604-8507, Japan
	TEL	+81-75-366-7703
	E-mail	kazuya@kuhp.kyoto-u.ac.jp
Contact for Public Queries	Contact Name	Kazuya Okamoto
	Contact Organization	Kyoto University Hospital
	Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 604-8507, Japan
	TEL	+81-75-366-7703
	E-mail	kazuya@kuhp.kyoto-u.ac.jp

Recruitment Status	COMPLETED

Date of First Enrollment		May. 01, 2019
Planned Number of Subjects		50
Nature of Investigation		Interventional
Study Design	Description of Trial Design	Parallel-Group Comparative Study
	Type of Control
	Trial Blinding Schema	open(masking not used)
	Randomized	Yes
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	healthy adults with 50 or more years of age; living in the region around Kyoto University Hospital (Sakyo Ward); with independent ambulation; willing to participate in a measurement of physical fitness, and minimal hearing and vision impairment.
	Exclusion Criteria	subjects unable to complete the tasks of the game due to reduced cognitive functions; subjects with dementia assessed with the Rapid Dementia Screening Test; subjects with severe cardiac, pulmonary, or musculoskeletal disorders; subjects with pathologies associated with increased risk of falls, such as Parkinson's disease or stroke; osteoporosis or psychotropic drug use.
	Minimum Age	50age old over
	Maximum Age	No limit
	Sex of Participants	Both
Trial Indication(s)		aged and aging people
Intervention(s)		Intervention type:BEHAVIOUR Name of intervention:smartphone application Dose form / Japanese Medical Device Nomenclature:OTHER Smartphone application Route of administration / Site of application:NOT APPLICABLE Dose per administration:n/a n/a n/a Dosing frequency / Frequency of use:OTHER, SPECIFY the time when examinee uses an application Planned duration of intervention:3 weeks Intended dose regimen:n/a detailes of teratment arms:n/a Comparative intervention name:active drug target Dose form / Japanese Medical Device Nomenclature:OTHER Route of administration / Site of application:NOT APPLICABLE Dose per administration:n/a n/a n/a Dosing frequency / Frequency of use:OTHER, SPECIFY the time when examinee uses an application Planned duration of intervention:3 weeks Intended dose regimen:n/a
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		physical activity
Secondary Outcome(s)		cognitive function

Primary Sponsor	Kazuya Okamoto
Secondary Sponsor

Sources of funding	Kyoto University

Name of Ethics Committee	Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethical Committe
Address
TEL
FAX
E-Mail
Ethics Committee Website	http://www.ec.med.kyoto-u.ac.jp/
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval	Approved

Date of approved	Feb. 06, 2018

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Secondary Study ID	JMA-IIA00314
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	May. 21, 2020	(this page)	Changes
1	Nov. 07, 2017	Detail

List of change history