UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047821 |
|---|---|
| Receipt number | R000054508 |
| Scientific Title | Study on the effect of art work on cognitive and living functions of the elderly |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2024/03/29 15:59:38 |
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Basic information
Public title
Study on the effect of art work on cognitive and living functions of the elderly
Acronym
Study on the effect of art work on cognitive and living functions of the elderly
Scientific Title
Study on the effect of art work on cognitive and living functions of the elderly
Scientific Title:Acronym
Study on the effect of art work on cognitive and living functions of the elderly
Region
| Japan |
Condition
Condition
Late-stage elderly requiring outpatient care
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine whether to improve cognitive function, motivation, motor / living function, and psychological well-being before and after art work, compared with the group that does not add art work to a normal recreation program.
It also aims to compare the results of volumetric morphological analysis of brain MRI and examine the mechanism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Revised Hasegawa's Dementia scale (HDS-R) (Changes before, 6 weeks, and 12 weeks after the start of art work)
Key secondary outcomes
Grip / pinch strength, Barthel index, Lawton's IADL rating scale, vitality index, geriatric depression scale, Lawton's psychological well-being scale (Changes before, 6 weeks, and 12 weeks after the start of art work)
Brain MRI morphology evaluation analysis before and after art work
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants in the art group (intervention group) will do art work once for 30 minutes, twice a week for 12 weeks, in addition to the usual recreation program.
Interventions/Control_2
The control group will do a normal recreation program for 12 weeks.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Late-stage elderly over 75 years old
2) Long-term care, support, and rehabilitation are required for mild dementia, cerebrovascular diseases, and trauma.
3) It is expected that they will be able to go to outpatient care for 2 days or more every week and continue art work for 3 months or more.
4) Even if there is cognitive dysfunction, it is possible to understand and perform the outline of art work.
5) They can tear off the masking tape with their finger and stick it.
Key exclusion criteria
1) Elderly people who have severe dementia, psychiatric symptoms, and upper limb movement disorders and cannot perform art work using masking tape.
2) Elderly people who are expected to be unable to continue or complete art work due to a serious underlying disease (cancer or disease with a poor prognosis).
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Tani |
Organization
Tokushima University Hospital
Division name
General Medicine and Primary Care
Zip code
770-8503
Address
50 Kuramoto-cho 2, Tokushima
TEL
088-633-9656
taniken@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Harutaka |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of General Medicine
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9656
Homepage URL
yharutaka@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
none
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
Clinical Research Review Board of Tokushima University
Address
50 Kuramoto-cho 2, Tokushima
Tel
088-633-7958
brinshoshienk@tokushima-u.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
| 2022 | Year | 06 | 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
42
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
| 2022 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 05 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054508
