UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003662 |
|---|---|
| Receipt number | 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 14:25:52 |
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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
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
shimada@ncgg.or.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004436
