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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037568
Receipt No. 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 2020/01/31

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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
Email 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
Email thayashi@nara.kindai.ac.jp

Sponsor
Institute Kindai University
Institute
Department

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
Email 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 No longer recruiting
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
2020 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042804

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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