UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Construction of new care preventive intervention program by developing comprehensive exercise supportive system
Title of the study (Brief title)	Effect of comprehensive exercise supportive system for care prevention
Region	Japan

Condition
Condition	Older people
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of comprehensive exercise support system for care prevention
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frenchay Activities Index
Key secondary outcomes	muscle strength, muscle mass, physical activity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment Behavior,custom Other
Interventions/Control_1	muscle strength trainging
Interventions/Control_2	Increase of physical activity
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Community dwelling older people attending care facility
Key exclusion criteria	Dementia Severe heart disease
Target sample size	70

Research contact person
Name of lead principal investigator	Koutatsu Nagai
Organization	Hyogo University of health sciences
Division name	Facalty of Rehabilitation
Address	6-3-1 minatojima tyu-o-ku, kobe
TEL	078-304-3047
Email	nagai-k@huhs.ac.jp

Public contact
Name of contact person	Koutatsu Nagai
Organization	Hyogo University of health sciences
Division name	Facalty of Rehabilitation
Address	6-3-1 minatojima tyu-o-ku, kobe
TEL	078-304-3047
Homepage URL
Email	nagai-k@huhs.ac.jp

Sponsor
Institute	Hyogo University of health sciences
Institute
Department

Funding Source
Organization	Hyogo University of health sciences
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 15 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 16 Day
Last modified on	2017 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020776