UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049752 |
|---|---|
| Receipt number | R000056667 |
| Scientific Title | virtual reality and cognitive function in middle-aged women |
| Date of disclosure of the study information | 2023/10/07 |
| Last modified on | 2023/10/06 12:29:28 |
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Basic information
Public title
Effect of individual virtual reality cognitive training programs on cognitive function and depression in middle-aged women
Acronym
virtual reality and cognitive function
Scientific Title
virtual reality and cognitive function in middle-aged women
Scientific Title:Acronym
virtual reality and cognitive function in middle-aged women
Region
| Asia(except Japan) |
Condition
Condition
Finished
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aimed to verify the effectiveness of cognitive and depression in virtual reality (VR)-based individual cognitive training programs, which are non-drug treatments, for middle-aged women who are exposed to the risk of cognitive impairment using VR technology
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Korean version of the Montreal Cognitive Assessment (K-MOCA), Digit Span Test (DST), Korean-Color Word Stroop Test (K-CWST), and the Korean version of the Short Form of Geriatric Depression Scale (SGDS-K)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Interventions/The training group underwent a VR-based individual cognitive training program twice a week for 12 weeks, 30 minutes at a time. Before the training, the participants received sufficient explanation and training on how to use the controller and operate the equipment for viewing control and auditory stimulation when wearing the HMD
Interventions/Control_2
Control/Self activity
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
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
Recruitment notice for middle-aged women age
Key exclusion criteria
Mental illnesses such as depression were excluded
Target sample size
60
Research contact person
Name of lead principal investigator
| 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
drkim4100@gmail.com
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
N/A
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Pusan National University Hospital
Address
179, Gudeok-Ro, Seo-Gu, Busan, 49241 Rep. of Korea
Tel
+82-51-240-7529
pnuhirb@naver.com
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
| 2023 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
60
Results
The results of the comparison before and after the VR-based cognitive training programs showed a significant increase in the K-MoCA score, which is a cognitive function evaluation (P<0.01). Moreover, a significant increase was observed in the DST forward and backward scores, which are cognitive function evaluations (P<0.01, P=0.01). Finally, a significant decrease was observed in the SGDS-K score, which is a measure of depression (P<0.01).
Results date posted
| 2022 | Year | 12 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
middle-aged women
Participant flow
N/A
Adverse events
N/A
Outcome measures
The Korean version of the Montreal Cognitive Assessment (K-MOCA), Digit Span Test (DST), Korean-Color Word Stroop Test (K-CWST), and the Korean version of the Short Form of Geriatric Depression Scale (SGDS-K)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | 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
| 2022 | Year | 12 | Month | 12 | Day |
Last modified on
| 2023 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056667
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