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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028663
Receipt No. R000032812
Scientific Title Effects of multicomponent exercise including home exercise program on cerebral blood flow in older adults with mild cognitive impairment: a single-center, non-randomized controlled trial
Date of disclosure of the study information 2017/09/01
Last modified on 2019/02/16

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Basic information
Public title Effects of multicomponent exercise including home exercise program on cerebral blood flow in older adults with mild cognitive impairment: a single-center, non-randomized controlled trial
Acronym Effects of multicomponent exercise on cerebral blood flow in older adults with mild cognitive impairment
Scientific Title Effects of multicomponent exercise including home exercise program on cerebral blood flow in older adults with mild cognitive impairment: a single-center, non-randomized controlled trial
Scientific Title:Acronym Effects of multicomponent exercise on cerebral blood flow in older adults with mild cognitive impairment
Region
Japan

Condition
Condition Amnestic mild cognitive impairment
Classification by specialty
Neurology Geriatrics Psychiatry
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of multicomponent exercise including home exercise program in older adults with mild cognitive impairment on cerebral image findings and cognitive function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cerebral blood flow
Key secondary outcomes Cognitive function, Physical function, Brain atrophy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 multicomponent exercise included home exercise education
Interventions/Control_2 Control group
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 A score of 0.5 in the Clinical Dementia Rating Scale Japanese
Diagnosis of amnestic mild cognitive impairment
The subject who has consent of principal or substitute person for research participation
Key exclusion criteria Mini-Mental State Examination is less than 24 points
Diagnosis of dementia
The subject who have painful exerciser disease, cardiovascular disease and metabolic disease difficult to participate in class
Diagnosis of non-amnestic mild cognitive impairment
History of cerebrovascular disease
The subject who is in care residence
Target sample size 56

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yota Kunieda
Organization Tokyo saiseikai central hospital
Division name Dementia center
Zip code
Address 1-4-17, Mita, Minato-ku, Tokyo
TEL 03-3451-8211
Email kunieda.999@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yota Kunieda
Organization Tokyo saiseikai central hospital
Division name Dementia center
Zip code
Address 1-4-17, Mita, Minato-ku, Tokyo
TEL 03-3451-8211
Homepage URL
Email kunieda.999@gmail.com

Sponsor
Institute Tokyo saiseikai central hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 09 Month 01 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 No longer recruiting
Date of protocol fixation
2017 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 08 Month 31 Day
Date trial data considered complete
2019 Year 08 Month 31 Day
Date analysis concluded
2019 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 15 Day
Last modified on
2019 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032812

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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