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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017805
Receipt No. R000020632
Scientific Title Effects of Dementia Prevention Class with exercise intervention as well as the addition of social interaction
Date of disclosure of the study information 2015/06/04
Last modified on 2019/12/10

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Basic information
Public title Effects of Dementia Prevention Class with exercise intervention as well as the addition of social interaction
Acronym Effects of Dementia Prevention Class with exercise intervention as well as the addition of social interaction
Scientific Title Effects of Dementia Prevention Class with exercise intervention as well as the addition of social interaction
Scientific Title:Acronym Effects of Dementia Prevention Class with exercise intervention as well as the addition of social interaction
Region
Japan

Condition
Condition Elderly people with mild cognitive impairment
Classification by specialty
Psychiatry Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To make clear the effects of the addition of social interaction into exercise-based Dementia Prevention Class
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Japanese version of Montreal Cognitive Assessment(MoCA-J) will be evaluated at time of intervention as well as three months after commencement of intervention, and one year after commencement of intervention
Key secondary outcomes Physical function, the TMIG Index of Competence, a 15-item Geriatric Depression Scale, SF-8 health survey, the japanese version of the abbreviated Lubben Social Network Scale and so on will be evaluated at time of intervention as well as three months after commencement of intervention, and nine months after commencement of intervention

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom Other
Interventions/Control_1 Aerobic, dual-task, and group work once a week for a period of three months, 12 sessions total
Interventions/Control_2
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Elderly people with mild cognitive impairment as well as those without
Key exclusion criteria People who have already been diagnosed with dementia, people living with assistance
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yoshitaka
Middle name
Last name SHIBA
Organization Kitasato University
Division name School of Allied Health Sciences
Zip code 252-0373
Address Kanagawa prefecture, Sagamihara city, Minami ward 1-15-1, 252-0373
TEL 042-778-9693
Email y-shiba@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Yoshitaka
Middle name
Last name SHIBA
Organization Kitasato University
Division name School of Allied Health Sciences
Zip code 252-0373
Address Kanagawa prefecture, Sagamihara city, Minami ward 1-15-1, 252-0373
TEL 042-778-9693
Homepage URL
Email y-shiba@kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Allied Health Sciences
Institute
Department

Funding Source
Organization Sasakawa Sports Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kitasato University School of Allied Health Sciences institutional review board
Address Kanagawa prefecture, Sagamihara city, Minami ward 1-15-1, 252-0373
Tel 042-778-9616
Email matsumi@kitasato-u.ac.jp

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
2015 Year 06 Month 04 Day

Related information
URL releasing protocol https://obirin.repo.nii.ac.jp/?action=repository_uri&item_id=1973&file_id=22&file_no=1
Publication of results Published

Result
URL related to results and publications https://obirin.repo.nii.ac.jp/?action=repository_uri&item_id=1973&file_id=22&file_no=1
Number of participants that the trial has enrolled 33
Results There were no significant differences during the three phases of measurement in cognitive function, social network, and quality of
life. While in physical function, TUG was
significantly lower at post evaluation than follow up evaluation, and walking steps were significantly higher at post evaluation
than pre evaluation.
Results date posted
2019 Year 12 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Elderly people (n=167), excepting individuals who received a diagnosis of dementia and
impaired activities of daily living
Participant flow They screened using the Touch Panel- type
Dementia Assessment Scale (TDAS).
The inclusion criterion for the programs was a TDAS score of 3 to 13. A total of 33
elderly participated in the study.
Adverse events nothing
Outcome measures physical function, MoCA-J, LSNS-6, SF-8
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
2015 Year 05 Month 28 Day
Anticipated trial start date
2015 Year 06 Month 04 Day
Last follow-up date
2017 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 04 Day
Last modified on
2019 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020632

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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