UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037568 |
|---|---|
| Receipt number | R000042804 |
| Scientific Title | Improving cognitive function of elderly people by flower arrangement with cognitive task |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2021/01/31 20:38:52 |
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Basic information
Public title
Effects of flower arrangement on frontal blood flow in elderly people with dementia
Acronym
Effects of flower arrangement on frontal blood flow in elderly people with dementia
Scientific Title
Improving cognitive function of elderly people by flower arrangement with cognitive task
Scientific Title:Acronym
Improving cognitive function of elderly people by flower arrangement with cognitive task
Region
| Japan |
Condition
Condition
Dementia excluding frontotemporal lobar degeneration, cerebrovascular dementia, Lewy body dementia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether flower arrangement is effective as a means to increase blood flow in the frontal lobe of elderly people with dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Temporal blood flow change in frontal lobe
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
flower arrangement(About 10 minutes once a day, onece a day)
Interventions/Control_2
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
1. An elderly person aged 65 or over who is in a nursing home for the elderly
2. A person who has been diagnosed by the attending physician with dementia other than frontotemporal lobe degeneration, cerebrovascular dementia and Lewy body dementia and is permitted to participate in the experiment
3. HDS-R score below 20
4. A person who explained the research content and obtained written consent from the target person or his / her family
5. Right-handed person
Key exclusion criteria
1. Those who do not meet the eligibility standard.
2. If you are in a serious behavior or mental state.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Hayashi |
Organization
Kindai University
Division name
Agricultural production science
Zip code
631-8505
Address
3327-204 Nakamachi,Nara City,Nara,JAPAN
TEL
0742-43-1511
thayashi@nara.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Hayashi |
Organization
Kindai University
Division name
Agricultural production science
Zip code
631-8505
Address
3327-204 Nakamachi,Nara City,Nara,JAPAN
TEL
0742-43-1511
Homepage URL
thayashi@nara.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
None
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
Kindai University
Address
3327-204 Nakamachi,Nara city,Nara,JAPAN
Tel
0742431894
syomu-info@nara.kindai.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
| 2019 | Year | 08 | 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
20
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
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2019 | Year | 08 | Month | 01 | Day |
Last modified on
| 2021 | 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=R000042804
