UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033694
Receipt number R000038414
Scientific Title Study on the efficacy of a system for alleviating cognitive impairment in mild cognitive impairment or mild dementia
Date of disclosure of the study information 2018/08/09
Last modified on 2020/08/11 09:39:43

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Basic information

Public title

Study on the efficacy of a system for alleviating cognitive impairment in mild cognitive impairment or mild dementia

Acronym

Efficacy of a system for alleviating cognitive impairment

Scientific Title

Study on the efficacy of a system for alleviating cognitive impairment in mild cognitive impairment or mild dementia

Scientific Title:Acronym

Efficacy of a system for alleviating cognitive impairment

Region

Japan


Condition

Condition

mild cognitive impairment, mild dementia

Classification by specialty

Geriatrics Psychiatry Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigated the efficacy of a combined exercise and cognitive training system for alleviating cognitive impairment and behavioral and psychological symptoms, improvement of ADL, and alleviating caregiver burden in adults with mild cognitive impairment or mild dementia.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in the scores of the Mini Mental State Examination (MMSE) during the period from immediately before the intervention to 3 months after the intervention.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment Other

Interventions/Control_1

Intervention group: exercise and cognitive training at a frequency of at least once a week, 5 minutes each time, 3 months

Interventions/Control_2

Control group: exercise only at a frequency of at least once a week, 5 minutes each time, 3 months

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


Not applicable

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

Subject with mild cognitive impairment or mild dementia
1. with Clinical Dementia Rating (CDR) = 0.5 or 1.
2. withe Mini-Mental State Examination (MMSE) score >= 20.
3. who are age less than 90 years old.
4. who are living at home and living with caregivers.
5. who can pedal an arm ergometer.
6. for whom consent is obtained from the
subjects or their family in writing.

Caregivers
1. who are living with the subjects and provide care mainly.
2. for whom consent is obtained in writing.

Key exclusion criteria

Subject with mild cognitive impairment or
mild dementia
1. who need a management of a medical risk required because of heart disease.
2. who has orthopedic disease or pain in shoulder, elbow, or wrist joint.
3. whom a principal investigator judges unsuitable for participating in the present study.

Caregivers
1. whom a principal investigator judges unsuitable for participating in the present
study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hitoshi Okamura

Organization

Hiroshima University

Division name

Graduate School of Biomedical & Health Sciences

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima

TEL

082-257-5450

Email

hokamura@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hitoshi Okamura

Organization

Hiroshima University

Division name

Graduate School of Biomedical & Health Sciences

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima

TEL

082-257-5450

Homepage URL


Email

hokamura@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 08 Month 09 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


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

2018 Year 06 Month 22 Day

Date of IRB

2018 Year 08 Month 08 Day

Anticipated trial start date

2018 Year 08 Month 09 Day

Last follow-up date

2020 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

2018 Year 08 Month 09 Day

Last modified on

2020 Year 08 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038414


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name