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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026479
Receipt No. R000030411
Scientific Title System construction and effect of the population-based approach for prevention of dementia
Date of disclosure of the study information 2017/03/09
Last modified on 2017/05/13

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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
Middle name
Last name Hiroyuki Shimada
Organization National Center for Geriatrics and Gerontology
Division name Department of Preventive Gerontology
Zip code
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
Middle name
Last name Sangyoon Lee
Organization National Center for Geriatrics and Gerontology
Division name Section of Cohort Study for Longevity, Department of Preventive Gerontology
Zip code
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
Address
Tel
Email

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
2017 Year 05 Month 13 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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