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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014437
Receipt No. R000016788
Scientific Title Development and validation of intervention program for prevention of dementia in community-dwelling older adults
Date of disclosure of the study information 2014/07/04
Last modified on 2016/02/25

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Basic information
Public title Development and validation of intervention program for prevention of dementia in community-dwelling older adults
Acronym Development and validation of intervention program for prevention of dementia in community-dwelling older adults
Scientific Title Development and validation of intervention program for prevention of dementia in community-dwelling older adults
Scientific Title:Acronym Development and validation of intervention program for prevention of dementia in community-dwelling older adults
Region
Japan

Condition
Condition Older adults with cognitive complaints
Classification by specialty
Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of intervention programs including different exercises on cognitive function in older adults with cognitive complaints.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitive function: Wechsler Memory Scale-Revised, Trail making test, Verbal fluency test, Stroop test, Digit symbol substitution test
Key secondary outcomes Cognitive function:Mini-Mental State Examination, ADAS-J-cog, Rey Auditory Verbal Learning Test, Montreal Cognitive Assessment, Clock Drawing test, Frontal Assessment Battery, Wisconsin card sorting test, Rey complex figure test

Physical function: muscle strength, gait analysis, six minutes walk, balance function
Body composition: Skeletal muscle mass, amount of body fat
Activity: Life-space assessment, International Physical Activity Questionnaire, pedometer, Tokyo Metropolitan Institute of Gerontology Index of Competence
Health related characteristics: Geriatric Depression Scale, Apathy scale, fall, QOL, Fall efficacy scale, Lubben Social Network Scale

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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Aerobic training group: supervised aerobic training for 6 months
Interventions/Control_2 Resistance training group: supervised resistance training for 6 months
Interventions/Control_3 Aerobic and resistance training group: supervised aerobic and resistance training for 6 months
Interventions/Control_4 Control group: Lecture about disease and health (2 times per 6 months)
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. Having cognitive complaints
2. Being independent in activity of daily livin
3. Being agreed with participation in the study
Key exclusion criteria 1. Diagnosed as dementia
2. History of cerebrovascular disease
3. Having serious disease which requires exercise limitation (i.e., cardiovascular, respiratory, neurological, ophthalmic, orthopedic disease )
4. Needing long-term care
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Kuzuya
Organization Nagoya University
Division name Department of Community Healthcare & Geriatrics, Graduate School of Medicine
Zip code
Address 65 Tsurumai, Showa-ku, Nagoya, Aichi 466-8550, Japan
TEL 052-744-2369
Email kuzuya@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Umegaki
Organization Nagoya University
Division name Department of Community Healthcare & Geriatrics, Graduate School of Medicine
Zip code
Address 65 Tsurumai, Showa-ku, Nagoya, Aichi 466-8550, Japan
TEL 052-744-2364
Homepage URL
Email umegaki@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Toyota City Hall
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 豊田市内の施設(愛知県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 04 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 Enrolling by invitation
Date of protocol fixation
2014 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2014 Year 11 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 07 Month 01 Day
Last modified on
2016 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016788

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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