UMIN-CTR Clinical Trial

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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