UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051472 |
|---|---|
| Receipt number | R000058716 |
| Scientific Title | Effect of eSports for community-dwelling elderly with mild cognitive impairment -preliminary study- |
| Date of disclosure of the study information | 2023/08/25 |
| Last modified on | 2024/06/28 16:04:31 |
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Basic information
Public title
Effect of eSports for community-dwelling elderly with mild cognitive impairment
Acronym
Effect of eSports for elderly with MCI
Scientific Title
Effect of eSports for community-dwelling elderly with mild cognitive impairment -preliminary study-
Scientific Title:Acronym
Effect of eSports for community-dwelling elderly with MCI
Region
| Japan |
Condition
Condition
mild cognitive impairment
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate whether eSports can improve the cognitive function and psychiatry symptoms in community-dwelling elderly with mild cognitive impairment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will evaluate the cognitive funtion and psychitaric symptoms by using the Montreal Cognitive Assessment(MoCA-J), Trail Making Test A, B(TMT-A, B), Geriatric depression scale 15(GDS-15),
and Starkstein Apathy Scale at before and at 9 weeks after intervention.
Key secondary outcomes
We will evaluate the brain activitiy by using the functional near-infrared spectroscopy at before and at 9 weeks after intervention.
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
eSports in once/ week, 60 minutes for 8 weeks
Interventions/Control_2
daily life as usual
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
a.MoCA-J: 25 points of less
b.almost independent in ADL
c.consent to participate in this study
Key exclusion criteria
a. Those who diagnosed with dementia or take antidementia drugs
b. Those who are visually or hearing impaired
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hayashi |
Organization
Fukushima Medical University School
Division name
Health Sciences
Zip code
960-8516
Address
Department of Occupational Therapy, Fukushima Medical University School of Health Sciences, 10-6 Sakaemachi, Fukushima 960-8516, Japan
TEL
0245815555
hhayashi@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hayashi |
Organization
Fukushima Medical University School
Division name
Health Sciences
Zip code
960-8516
Address
10-6 Sakaemachi, Fukushima 960-8516, Japan
TEL
0245815555
Homepage URL
hhayashi@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University School
Institute
Department
Personal name
Hiroshi Hayashi
Funding Source
Organization
Fukushima Medical University School
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
Fukushima Medical University School
Address
1 Hikarigaoka, Fukushima, 960-1295,Japan
Tel
09019387374
c-kiban@fmu.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
| 2023 | Year | 08 | Month | 25 | 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
No significant differences were found regarding age, sex ratio, education history between the two groups.The total scores of MoCA-J showed improvement in the intervention and control groups , but the group interaction was not significant. TMT-A, B, GDS-15, and SAS showed no significant changes in the two groups.The mean values of the oxy-Hb decreased significantly in the intervention group and increased significantly in the control group.
Results date posted
| 2024 | Year | 06 | Month | 28 | Day |
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
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | 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
| 2023 | Year | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058716
