UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039518 |
|---|---|
| Receipt number | R000045055 |
| Scientific Title | Effects of various program interventions using non-drug therapy on cognitive function, activities of daily living, quality of life, and physical pain in very elderly people aged 90 years or older with Alzheimer's type dementia: Targeting residents of geriatric health services facility. |
| Date of disclosure of the study information | 2020/02/22 |
| Last modified on | 2025/02/15 13:14:53 |
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Basic information
Public title
Effects of various program interventions using non-drug therapy on cognitive function, activities of daily living, quality of life, and physical pain in very elderly people aged 90 years or older with Alzheimer's type dementia: Targeting residents of geriatric health services facility.
Acronym
NRCT
Scientific Title
Effects of various program interventions using non-drug therapy on cognitive function, activities of daily living, quality of life, and physical pain in very elderly people aged 90 years or older with Alzheimer's type dementia: Targeting residents of geriatric health services facility.
Scientific Title:Acronym
NRCT
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study I would like to confirm whether various interventions such as rehabilitation,learning therapy,music therapy and dog therapy so on are beneficial or not on Alzheimer's disease .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
I would like to assess the beneficial effects on cognitive functions, activities of daily living and QOL using various programs such as rehabilitation, learning therapy, music therapy, dog therapy for patients with Alzheimer's disease.
Key secondary outcomes
We check HDS-R,MMSE,FAB,
BI,FIM,QOL,MOBID-2 before the elderly enters the facility and after about 3 months they spends the facility. We check the value of every checking items and then compare the values.These Various interventions will lead the elderly people
to go back their own home .
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Rehabilitation
Individual rehabiritation takes place three times a week for 20~40 minutes per time.
Interventions/Control_2
Learning therapy
Individual or 1:2 learning therapy takes place three times a week for 20~30 minutes per time.
Interventions/Control_3
Music therapy
Group therapy takes place three times a week for 30 minutes per time and individual one takes place a few times a week for 15~30 minutes per time
Interventions/Control_4
Dog therapy
Group therapy takes place almost everyday for 30~60 minutes per time and individual one takes place once a week for 30 minuues per time.
Interventions/Control_5
School curriculum system
There are 3 classes a day ( 30 minutes a class) except Sunday.
After school activities also take place everyday except Sunday for 30 minutes a time.
Interventions/Control_6
Elective after school activities take place once a month. Patients can choose one of the activities which they may request before. These activities make them independent.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 90 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We choose 20 patients over 90-years old. These patients are diagnosed with Alzheimer's disease by their general practitioners or neurologists.
Key exclusion criteria
1,Patients who are taking drugs that affect cognitive function(Benzodiazepine,Antideoressant,
Central nervous system drugs)
2,Before and after the intervention period, or no intervention period, patients can not join checking items.
3,Patients who are currently join another trial or have joined some within 3 months.
4,Patients who have experienced some interventions when they were at home.
5, Patients who have an animal allergy.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ryuta |
| Middle name | |
| Last name | Kawashima |
Organization
Touhoku University
Aging Institute
Division name
Brain science
Zip code
980-8575
Address
4-1 Seryou Aoba Sendai
TEL
022-717-7988
ryuta.kawashima.a6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Mori |
Organization
Tohoku University Aging Institute
Division name
Brain sc
Zip code
980-8575
Address
ience
TEL
022-717-7988
Homepage URL
vs901loveyuko@gmail.com
Sponsor or person
Institute
Tohoku University Aging Institute
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Rehabilitation Facility For The Elderly Okayama Adult school
Name of secondary funder(s)
Special Elderly Nursing Home
Keiryuso
IRB Contact (For public release)
Organization
Tohoku University Aging Institute
Address
4-1 Seiryo Aoba Sendai
Tel
022-717-7988
vs901loveyuko@gmail.com
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
岡山県津山市日本原352
介護老人保健施設おとなの学校岡山校
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 22 | 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
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
During my research, I had a health problem so I had to stop my research for a while. However, I am going to continue to research.
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 | 12 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 05 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 05 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 05 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 05 | Day |
Other
Other related information
During my research I had a health problem, but I am going to continue my research .
Management information
Registered date
| 2020 | Year | 02 | Month | 17 | Day |
Last modified on
| 2025 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045055
