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 2024/03/04 21:14:26

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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

Email

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


Email

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

Email

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

Open public 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

2025 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



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

2024 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045055


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name