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
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
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
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
