UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042129 |
|---|---|
| Receipt number | 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 16:07:45 |
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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
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
drkim4100@gmail.com
Sponsor or person
Institute
Pusan National University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048084
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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