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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033694
Receipt No. R000038414
Official scientific title of the study 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 2018/08/09

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Basic information
Official scientific title of the study Study on the efficacy of a system for alleviating cognitive impairment in mild cognitive impairment or mild dementia
Title of the study (Brief title) 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 Hitoshi Okamura
Organization Hiroshima University
Division name Graduate School of Biomedical & Health Sciences
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5450
Email hokamura@hiroshima-u.ac.jp

Public contact
Name of contact person Hitoshi Okamura
Organization Hiroshima University
Division name Graduate School of Biomedical & Health Sciences
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5450
Homepage URL
Email hokamura@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 22 Day
Anticipated trial start date
2018 Year 08 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 09 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.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


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