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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007749
Receipt No. R000009121
Scientific Title Effects of exercise on cognitive functions in the elderly adults with mild cognitive impairment: a randomized controlled trial
Date of disclosure of the study information 2012/04/15
Last modified on 2016/04/13

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Basic information
Public title Effects of exercise on cognitive functions in the elderly adults with mild cognitive impairment: a randomized controlled trial
Acronym A randomized control trial for preventing decline of cognitive functions in the elderly with MCI
Scientific Title Effects of exercise on cognitive functions in the elderly adults with mild cognitive impairment: a randomized controlled trial
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 YES

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: Wechsler Memory Scale-Revised Logical Memory , Rey Auditory Verbal Learning Test, word list memory
Key secondary outcomes Cognitive function: Digit span, modified digit symbol substitution test, verbal fluency, modified trail making test, flanker test, backward counting
Brain volumetry: MRI
Brain function: FDG PET and fNIRS
Physical function: muscle strength, gait analysis, six minutes walk, balance control
Activity: Tokyo Metropolitan Institute of Gerontology Index of Competence, Life-space assessment, Physical Activity Scale for the Elderly, pedometer
Health related characteristics: apathy, pain, fall, QOL, Pittsburgh Sleep Quality Index, fall efficacy scale, gait efficacy scale, social activity

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 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) Elderly people, aged 65 over and living in Obu city, having health check from Aug in 2011 to Feb in 2012.
2) Fullfilled Peterson's criteria (a: cognitive function is 1.5 SD or more below the normative values; b: score of more than 24 on the Mini-Mental State Examination; c: not diagnosed dementia; d: being independent in activity of daily living; e: having a complain of subjective memory problem)
3) Being agreed with participation in the study
Key exclusion criteria 1) Having serious or unstable illnesses
2) History of psychiatric disease
3) Receiving of anti-Alzheimer drugs
4) Geriatrics Depression Scale > 5
5) Needing long-term care
Target sample size 308

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 0562445651
Email jiritsu@ncgg.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shimada Hiroyuki
Organization National Center for Geriatrics and Gerontology
Division name Department for Research and Development to Support Independent Life of Elderly
Zip code
Address 35 Gengo, Moriokacho, Obu, Aichi, 474-8511, Japan
TEL 0562445651
Homepage URL
Email jiritsu@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare (Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Ministry of Education Science and Culture of Japan.

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 大府市市内の施設

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 15 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
2011 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 01 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
2012 Year 04 Month 13 Day
Last modified on
2016 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009121

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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