UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023283 |
|---|---|
| Receipt number | R000026827 |
| Scientific Title | Study on Effect of Multimodal Dementia Prevention Program in Community- Dwelling Elderly |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2021/12/22 15:37:24 |
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Basic information
Public title
Study on Effect of Multimodal Dementia Prevention Program in Community-
Dwelling Elderly
Acronym
Study on Effect of Multimodal Dementia Prevention Program in Community-
Dwelling Elderly
Scientific Title
Study on Effect of Multimodal Dementia Prevention Program in Community-
Dwelling Elderly
Scientific Title:Acronym
Study on Effect of Multimodal Dementia Prevention Program in Community-
Dwelling Elderly
Region
| Japan |
Condition
Condition
healthy community-dwelling elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether dementia prevention exercise is associated with a reduced risk for dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mini mental state examination
Key secondary outcomes
CFI, EQ-5D, Five Cog, Timed Up & Go test, Physical Activity Scale for the Elderly and Geriatric Depression Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Group1: intensive training and booster training group
intensive training: once a week for 10 weeks
booster training: once every 3 months
training: physical exercise, dual task training, cognitive exercise, nutritional guidance
Interventions/Control_2
Group2: intensive training group
intensive training: once a week for 10 weeks
no booster training
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy community-dwelling elderly
Key exclusion criteria
people with dementia
walking difficulty
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kajita |
Organization
Kobegakuin university
Division name
Faculty of rehabilitation
Zip code
6512180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe, Japan
TEL
078-974-1551
kajita@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kajita |
Organization
Kobegakuin university
Division name
Faculty of rehabilitation
Zip code
6512180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe, Japan
TEL
078-974-1551
Homepage URL
kajita@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Faculty of rehabilitation, Kobegakuin university
Institute
Department
Personal name
Funding Source
Organization
World Health Organizati
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobegakuin university
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe, Japan
Tel
0789741551
kajita@reha.kobegakuin.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 22 | Day |
Last modified on
| 2021 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026827
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
