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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003662
Receipt No. R000004436
Scientific Title A randomized control trial for preventing decline of cognitive functions in the community living elderly with mild cognitive impairment
Date of disclosure of the study information 2010/06/01
Last modified on 2013/01/18

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Basic information
Public title A randomized control trial for preventing decline of cognitive functions in the community living elderly with mild cognitive impairment
Acronym A randomized control trial for preventing decline of cognitive functions in the elderly with MCI
Scientific Title A randomized control trial for preventing decline of cognitive functions in the community living elderly with mild cognitive impairment
Scientific Title:Acronym A randomized control trial for preventing decline of cognitive functions in the elderly with MCI
Region
Japan

Condition
Condition mild cognitive impairment
Classification by specialty
Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of physical exercise on cognitive decline in elderly with mild cognitive impairment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitive function: ADAS
Brain volumetry: MRI
Brain function: FDG PET and fNIRS
Key secondary outcomes Cognitive functions: Mini-mental state examination, Clinical dementia rating, Wechsler memory scale-R, Digit span, Stroop test, SDMT, Word fluency, Trail making test, Geriatric depression scale, Clock drawing, VBTA, Ray-Osterrieth complex figure test, Raven's Colored Progressive Matrices, Key search test, A part of standard language test of aphasia
Physical functions: muscle strength, gait performance
Activity: Tokyo Metropolitan Institute of Gerontology Index, Life-space assessment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group: Supervised aerobic exercise for 1 year
Interventions/Control_2 Control group: Lecture about disease and 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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Living in Obu city
2) CDR 0.5
3) give a written informed consent to the participation in the present study
Key exclusion criteria 1) Having serious or unstable illnesses
2) history of psychiatric disease
3) Receiving of anti-Alzheimer drugs
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Suzuki Takao
Organization National Center for Geriatrics and Gerontology
Division name Research Institute
Zip code
Address 35 Gengo, Moriokacho, Obu, Aichi, 474-8511, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shimada Hiroyuki
Organization National Center for Geriatrics and Gerontology
Division name Section for Health Promotion
Zip code
Address 35 Gengo, Moriokacho, Obu, Aichi, 474-8511, Japan
TEL
Homepage URL
Email shimada@ncgg.or.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization Obu city
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

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 NPOネットワーク大府

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2010 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 05 Month 25 Day
Last modified on
2013 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004436

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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