UMIN-CTR Clinical Trial

Basic information
Public title	System construction and effect of the population-based approach for prevention of dementia
Acronym	Effect of the population-based approach for prevention of dementia
Scientific Title	System construction and effect of the population-based approach for prevention of dementia
Scientific Title:Acronym	Effect of the population-based approach for prevention of dementia
Region	Japan

Condition
Condition	65 year old or older with mid cognitive impairment (MCI)
Classification by specialty	Neurology Geriatrics Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine whether participating in social, cognitive and physical activities for promoting going outdoors is useful for improving cognition in older adults with MCI
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	National Center for Geriatrics and Gerontology-Functional Assessment Tool (NCGG-FAT):Attention, Memory, Executive function, processing speed
Key secondary outcomes	Neuroimaging method: Magnetic Resonance Imaging (MRI) Physical function: Grip strength, Gait, Anthropometry, Body composition Activities of daily living: Kihon checklist, Instrumental Activities of Daily Living (IADL), Measure the time of conversation, physical activity Psychological function: Quality of Life (QOL), Geriatric Depression Scale (GDS)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group: Participation in social, cognitive and physical activities for promoting going outdoors among older adults with MCI, taking place in 48 sessions during 6 months
Interventions/Control_2	Control group: Lectures on health for older adults with MCI, taking place in 2 sessions during 6 months
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	1)Older adults over 65 years old, who have participated in the National Center for Geriatrics and Gerontology-Study of Geriatric Syndromes(NCGG-SGS) 2)Japanese speakers with suspected MCI 3)Informed written consent
Key exclusion criteria	1)Parkinson's disease 2)Depression 3)Dementia 4)Use of a pacemaker 5)Medically advised not to participate in exercise 6)Restrict of basic activities of daily living (BADL) 7)Death and moving out after NCGG-SGS 8)Use of long-term care insurance 9)Potential participation in other project 10)Administrator of social welfare commissioner or provider of activities during going outdoors 11)People who have going out every day
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Shimada
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Preventive Gerontology
Zip code	474-8511
Address	7-430 Morioka-cho, Obu City, Aichi Prefecture
TEL	0562-44-5651
Email	shimada@ncgg.go.jp

Public contact
Name of contact person	1st name Sangyoon Middle name Last name Lee
Organization	National Center for Geriatrics and Gerontology
Division name	Section of Cohort Study for Longevity, Department of Preventive Gerontology
Zip code	474-8511
Address	7-430 Morioka-cho, Obu City, Aichi Prefecture
TEL	0562-45-5638
Homepage URL
Email	sylee@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology, Section of Cohort Study for Longevity, Department of Preventive Gerontology
Institute
Department

Funding Source
Organization	MEXT(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Center for Geriatrics and Gerontology
Address	7-430 Morioka-cho, Obu City, Aichi Prefecture
Tel	0562-46-2311
Email	yaday@ncgg.go.jp

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	国立研究開発法人国立長寿医療研究センター National Center for Geriatrics and Gerontology

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date	2017 Year 03 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 03 Month 09 Day
Last modified on	2021 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030411