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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042129
Receipt No. R000048084
Scientific Title Effects of ICT-based Multi-Cognition Program on Body Composition and Cognitive Function in Elder Adults: A Randomized Controlled Clinical Study
Date of disclosure of the study information 2020/10/15
Last modified on 2020/10/15

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Basic information
Public title Effects of ICT-based Multi-Cognition Program on Body Composition and Cognitive Function in Elder Adults: A Randomized Controlled Clinical Study
Acronym Multi-cognition program and older adults
Scientific Title Effects of ICT-based Multi-Cognition Program on Body Composition and Cognitive Function in Elder Adults: A Randomized Controlled Clinical Study
Scientific Title:Acronym Multi-cognition program and older adults
Region
Asia(except Japan)

Condition
Condition Finished
Classification by specialty
Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study was conducted to investigate the effects of an information and communication technology (ICT)-based multi-cognition program on body composition and cognitive function in elder adults.
Basic objectives2 Others
Basic objectives -Others cognitive function
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes body composition and cognitive function
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 ICT-based Multi-Cognition Program
multi-cognition program was applied on the exercise group twice per week, once per day for 12 weeks, at 30 min per session
Interventions/Control_2 Control
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
60 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) males and females at least 60 years of age, (2) can read and write, (3) have no limitations that prevent them from performing their activities in daily life, and (4) do not have any regular (i.e., more than twice a week) exercise habits.
Key exclusion criteria (1) other general conditions associated with dementia, such as, but not limited to, hypothyroidism, vitamin B12 or folate deficiency, niacin deficiency, hyperkalemia, neurosyphilis, and human immunodeficiency virus, (2) major psychiatric disorders, such as, but not limited to, schizophrenia, delusional disorders, bipolar disorder, and alcohol and/or substance abuse disorders, as diagnosed according to the DSM-5 diagnostic criteria, (3) difficulties that hamper assessment, e.g., due to visual and hearing impairments, (4) cardiovascular diseases, neurological diseases, unstable medical conditions, and other similar health disorders, and/or (5) ineligibility of the individual to participate in the trial for other reasons, as assessed by the principal investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Jong-Hwan
Middle name
Last name Park
Organization Pusan National University Hospital
Division name Biomedical Research Institute
Zip code 49241
Address 179, Gudeok-Ro, Seo-Gu, Busan, Rep. of Korea
TEL 82-51-240-7071
Email parkj@pusan.ac.kr

Public contact
Name of contact person
1st name Du-Ri
Middle name
Last name Kim
Organization Pusan National University Hospital
Division name Biomedical Research Institute
Zip code 49241
Address 179, Gudeok-Ro, Seo-Gu, Busan, Rep. of Korea
TEL 82-51-240-7071
Homepage URL
Email drkim4100@gmail.com

Sponsor
Institute Pusan National University Hospital
Institute
Department

Funding Source
Organization Pusan National University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Pusan National University Hospital
Address 179, Gudeok-Ro, Seo-Gu, Busan, Rep. of Korea
Tel 82-51-240-7529
Email yalee@pnuh.co.kr

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
2020 Year 10 Month 15 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 20
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
2019 Year 03 Month 01 Day
Date of IRB
2019 Year 06 Month 30 Day
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2020 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 10 Month 15 Day
Last modified on
2020 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048084

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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