UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042804