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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013097
Receipt No. R000015270
Scientific Title Effects of community-based activity program on cognitive function in community-dwelling older adults with cognitive impairment: A randomized control trial
Date of disclosure of the study information 2014/02/07
Last modified on 2020/09/29

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Basic information
Public title Effects of community-based activity program on cognitive function in community-dwelling older adults with cognitive impairment: A randomized control trial
Acronym A randomized control trial for reducing decline of cognitive functions in community-dwelling older adults
Scientific Title Effects of community-based activity program on cognitive function in community-dwelling older adults with cognitive impairment: A randomized control trial
Scientific Title:Acronym A randomized control trial for reducing decline of cognitive functions in community-dwelling older adults
Region
Japan

Condition
Condition mild to moderate cognitive impairment
Classification by specialty
Geriatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of community-based activity program on cognitive function in older adults with mild to moderate cognitive impairment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
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 Brain volumetry: MRI
Physical function: muscle strength, gait, six-minute walk, balance
Life function: Tokyo Metropolitan Institute of Gerontology Index of Competence, fall experience
Psychological function: QOL, depression (GDS), sleep (PSQI), pain, apathy, social skill, self-efficacy
Activity level: Life-space assessment, social activity, steps and physical activity, social network

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 Institution is not considered as adjustment factor.
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: exercise program in sport facilities (once a week) & small group (4 or 5 persons) activities in the community (about once a week) for 10 months
Interventions/Control_2 Control group: lecture on health (3 times per year)
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Living in Midori Ward, Nagoya City
2) 70 years old or more at April of 2013
3) Score from 20 to 25 on the Mini-Mental State Examination
4) Give a written informed consent to the participation in the present study
Key exclusion criteria 1) Have serious or unstable illnesses
2) Have difficulty in gait
3) Participant in other studies
Target sample size 300

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, 474-8511, Japan
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, 474-8511, Japan
TEL 0562-45-5638
Homepage URL
Email sylee@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization Japan science and technology agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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, 474-8511, Japan
Tel 0562-46-2311
Email sumiyami@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 緑区や大府市内の施設

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 07 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 280
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 Main results already published
Date of protocol fixation
2014 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 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
2014 Year 02 Month 06 Day
Last modified on
2020 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015270

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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