UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of home exercise program on the cognitive function of community dwelling elderly people
Title of the study (Brief title)	Home exercise program for the cognitive function
Region	Japan

Condition
Condition	community dwelling elderly people
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is evaluating the effect of a home exercise program on cognitive function in community dwelling elderly people.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Effect on cognitive function for baseline, 3-months, 6-months and a further period.
Key secondary outcomes	motor function

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Self exercise training with cognitive task at home
Interventions/Control_2	Self exercise training without cognitive task
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Living independently in community Agreeing with this study
Key exclusion criteria	Nursing care is necessary for living life Disagreeing with this study
Target sample size	60

Research contact person
Name of lead principal investigator	Kohei Maruya
Organization	Saitama medical university
Division name	Department of physical therapy, faculty of medical care
Address	Kawakado 981, Moroyama-town, Saitama prefecture
TEL	049-295-1001
Email	maruya@saitama-med.ac.jp

Public contact
Name of contact person	Kohei Maruya
Organization	Saitama medical university
Division name	Department of physical therapy, faculty of medical care
Address	Kawakado 981, Moroyama-town, Saitama prefecture
TEL	049-295-1001
Homepage URL
Email	maruya@saitama-med.ac.jp

Sponsor
Institute	Saitama medical university
Institute
Department

Funding Source
Organization	Saitama medical university
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	2018 Year 10 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 09 Month 01 Day
Anticipated trial start date	2018 Year 09 Month 20 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	2018 Year 09 Month 03 Day
Last modified on	2018 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038774