UMIN-CTR Clinical Trial

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
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)

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038414