UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014437 |
|---|---|
| Receipt number | 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 | 2021/03/22 15:08:03 |
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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
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
umegaki@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
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
| 2021 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016788
