UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032039 |
|---|---|
| Receipt number | R000036000 |
| Scientific Title | Effects of a dementia prevention program in communities with few social resource |
| Date of disclosure of the study information | 2018/04/09 |
| Last modified on | 2021/10/11 14:44:10 |
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Basic information
Public title
Effects of a dementia prevention program in communities with few social resource
Acronym
Effects of a dementia prevention program in communities
Scientific Title
Effects of a dementia prevention program in communities with few social resource
Scientific Title:Acronym
Effects of a dementia prevention program in communities
Region
| Japan |
Condition
Condition
well elderly and mild cognitive impairments
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to discuss effects of a dementia prevention program in communities with few social resource regards with a cognitive function, life style, physical fuctions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
D-CAT (1 week and 8 week)
5m walking speed (1 week and 8 week)
Standing time on one leg (1 week and 8 week)
life style change (8week)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
demenntia prevention program (study on dementia prevention, group activity, once a week) + exercise (onece a week)
Interventions/Control_2
exercise (onece a week)
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
eldely at community salons
Key exclusion criteria
severe cognitive dysfunction and walking dysfuction
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Nishida |
Organization
Prefectural University of Hiroshima
Division name
Graduate School of Comprehensive Scientific Research
Zip code
723-0053
Address
Hiroshima, Mihara-city, Gakuen-cho, 1-1
TEL
0848-60-1275
s-nisida@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Tabata |
Organization
Prefectural University of Hiroshima
Division name
Graduate School of Comprehensive Scientific Research
Zip code
723-0053
Address
Hiroshima, Mihara-city, Gakuen-cho, 1-1
TEL
090-4693-1232
Homepage URL
taba.t.716@gmail.com
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
Funding Source
Organization
Prefectural University of Hiroshima
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Prefectural University of Hiroshima
Address
Hiroshima, Mihara-city, Gakuen-cho, 1-1
Tel
0848-60-1120
s-nisida@pu-hiroshima.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
| 2018 | Year | 04 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 09 | 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
| 2018 | Year | 03 | Month | 31 | Day |
Last modified on
| 2021 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036000
