UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027792 |
|---|---|
| Receipt number | R000031849 |
| Scientific Title | Development research of Tottori-method dementia prevention program |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2019/01/31 19:12:44 |
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Basic information
Public title
Development research of Tottori-method dementia prevention program
Acronym
Development research of Tottori-method dementia prevention program
Scientific Title
Development research of Tottori-method dementia prevention program
Scientific Title:Acronym
Development research of Tottori-method dementia prevention program
Region
| Japan |
Condition
Condition
Community residents who are suspected of cognitive decline
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate whether dementia prevention program combining exercise, intellectual activity and lecture about dementia can improve the cognitive function in subjects who are suspected of cognitive decline.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The results of Touch Panel-type Dementia Assessment Scale (TDAS) after six months.
Key secondary outcomes
The results of physical function-related evaluation, lifestyle disease-related evaluation and MRI after six months.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
| Other |
Interventions/Control_1
First, dementia prevention program combining exercise, intellectual activity and classroom learning is performed once a week for 120 minutes a day for total of six months. After the intervention, we follow up without intervention for six months.
Interventions/Control_2
We observe without intervention during the first six months. Thereafter, dementia prevention program combining exercise, intellectual activity and classroom learning is performed once a week for 120 minutes a day for total of six months.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects who scored 10-13 points by simple computerized screening test (MSP; NIHON KOHDEN Corp, Tokyo, Japan) which was performed from April 1, 2016 to July 31, 2017 in Houki town.
2) Subjects who has already been diagnosed with dementia requires the consent from proxies.
Key exclusion criteria
1) Subjects who have a serious heart disease and are difficult to perform physical activity.
2) Subjects who cannot rise from sitting position at all.
3) If consent of MRI is obtained, subjects who have instruments and/or magnetic metals in the body.
4) Subjects who are assessed by the principal investigator due to other reasons.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuya Urakami |
Organization
School of Health Science, Faculty of Medicine, Tottori University
Division name
Department of Biological Regulation
Zip code
Address
86 Nishicho, Yonago, Tottori, Japan
TEL
0859-38-6354
kurakami@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Kouzuki |
Organization
School of Health Science, Faculty of Medicine, Tottori University
Division name
Department of Biological Regulation
Zip code
Address
86 Nishicho, Yonago, Tottori, Japan
TEL
0859-38-6358
Homepage URL
kouzuki@med.tottori-u.ac.jp
Sponsor or person
Institute
Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University
Institute
Department
Personal name
Funding Source
Organization
The Nippon Foundation and Tottori prefecture
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 26 | 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
Our results suggest that dementia prevention program combining exercise, intellectual activity and lecture about dementia is beneficial for improving the cognitive function and physical function in subjects who are suspected of cognitive decline.
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
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | 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
| 2017 | Year | 06 | Month | 16 | Day |
Last modified on
| 2019 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031849
