UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026479
Receipt number 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 2021/03/17 10:16:49

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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 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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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