UMIN-CTR Clinical Trial

Basic information
Public title	Study for evaluating clinical efficacy of a recreation program to improve cognitive abilities of elderly people in day care center using eye-tracking-based cognitive assessment.
Acronym	Study for evaluating clinical efficacy of a recreation program to improve cognitive abilities of elderly people in day care center using eye-tracking-based cognitive assessment.
Scientific Title	Study for evaluating clinical efficacy of a recreation program to improve cognitive abilities of elderly people in day care center using eye-tracking-based cognitive assessment.
Scientific Title:Acronym	Study for evaluating clinical efficacy of a recreation program to improve cognitive abilities of elderly people in day care center using eye-tracking-based cognitive assessment.
Region	Japan

Condition
Condition	Mild cognitive impairment
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is evaluating clinical efficacy of a recreation program to improve cognitive abilities of elderly people in day care center.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitive score measured by eye-tracking-based cognitive assessment after three months intervention
Key secondary outcomes	Barthel Index after three months intervention Dementia Behavior Disturbance Scale (DBD13) after three months intervention

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Three-month intervention period Motor-cognitive dual task trainig, 1-2 times per week
Interventions/Control_2	Three-month intervention period No intervention
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	People with mild coginitve impairment and at a risk of developing cognitive impairment.
Key exclusion criteria	People with severe hearing or visual impairment are excluded from the study.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Shuko Middle name Last name Takeda
Organization	Osaka university
Division name	Graduate school of medicine
Zip code	565-0871
Address	2-2 Yamada-oka, Suita
TEL	0662108351
Email	takeda@cgt.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Shuko Middle name Last name Takeda
Organization	Osaka university
Division name	Graduate school of medicine
Zip code	565-0871
Address	2-2 Yamada-oka, Suita
TEL	0662108351
Homepage URL
Email	takeda@cgt.med.osaka-u.ac.jp

Sponsor
Institute	Osaka university
Institute
Department

Funding Source
Organization	Solasto Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka university
Address	2-2 Yamada-oka, Suita
Tel	06-6210-8296
Email	handai-nintei@hp-crc.med.osaka-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	2022 Year 01 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	Preinitiation
Date of protocol fixation	2021 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date	2021 Year 12 Month 06 Day
Last follow-up date	2022 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	2021 Year 12 Month 04 Day
Last modified on	2021 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051545