UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055350 |
|---|---|
| Receipt number | R000063225 |
| Scientific Title | Development of a new health promotion program for older adults focusing on e-sports |
| Date of disclosure of the study information | 2024/08/27 |
| Last modified on | 2024/08/27 12:10:36 |
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Basic information
Public title
Development of a new health promotion program for older adults focusing on e-sports
Acronym
Development of a new health promotion program for older adults focusing on e-sports
Scientific Title
Development of a new health promotion program for older adults focusing on e-sports
Scientific Title:Acronym
Development of a new health promotion program for older adults focusing on e-sports
Region
| Japan |
Condition
Condition
Older adults without dementia
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Many studies have reported the effectiveness of cognitive training in improving cognitive functions, and brain training games are now widely used in Japan. In recent years, e-sports (competitive computer games) has been focused on as a new long-term care prevention program. However, these efforts have been limited to comparison of before and after groups of interventions, and no previous studies have been reported in the scientific literature. Therefore, the purpose of this study is to conduct an intervention program combining e-sports, exercise, and nutrition for community-dwelling older adults, and to examine the effects of the program on improving the physical and cognitive functions of the older adults.
Basic objectives2
Others
Basic objectives -Others
This will enable the proposal of new activities to those who have not been interested in exercise-centered social group activity and encourage them to participate. E-sports can be used as an entrance for the older adults to promote their health and wellness.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in cognitive function before and 12 weeks after the start of the intervention program. Specific measures included general cognitive function (Mini-Mental State Examination-Japanese: MMSE-J, Japanese version of Montreal Cognitive Assessment: MoCA-J), attention and executive function (Trail Making-Test (TMT), visual memory range, number counting, and Tower of Hanoi.
Key secondary outcomes
Changes in daily living behavior and living conditions before and 12 weeks after the start of the intervention program. Daily living behavior will be measured by having the participants wear a wearable device on the opposite wrist of their dominant hand for one week, and physical activity, sedentary time, and sleep duration will be measured. The living conditions and diet survey will be measured in terms of meal frequency, sleep status, social interaction, and lifestyle awareness.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Participants in the intervention group will be asked to gather at the venue once a week for a 90-minute program (12 sessions in total). The program will consist of 60 minutes of e-sports (competition among participants using rhythm and puzzle games), 15 minutes of warm-up exercises (exercises and light strength training), and 15 minutes of a health lecture (nutrition and oral health lecture).
Interventions/Control_2
The control group will be asked to wait for the intervention group during the period of the program (12 weeks). After the post-intervention measurements and surveys are completed, the e-sports and the health lecture programs will be conducted twice.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Older adults aged 65 years or older who have agreed to the content of this study.
Key exclusion criteria
Those who score 23 or less on the Mini-Mental State Examination-Japanese. Those who are unable to participate in at least 80% of the entire intervention program.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Nemoto |
Organization
Kanagawa University of Human Services
Division name
Graduate School of Health Innovation
Zip code
210-0821
Address
Research Gate Building TONOMACHI 2A 2,3F 3-25-10 Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
044-223-6510
y.nemoto-qx5@kuhs.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Nemoto |
Organization
Kanagawa University of Human Services
Division name
Graduate School of Health Innovation
Zip code
210-0821
Address
Research Gate Building TONOMACHI 2A 2,3F 3-25-10 Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
044-223-6510
Homepage URL
y.nemoto-qx5@kuhs.ac.jp
Sponsor or person
Institute
Kanagawa University of Human Services
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi 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
Kanagawa University of Human Services Graduate School of Health Innovation
Address
Research Gate Building TONOMACHI 2A 2,3F 3-25-10 Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa
Tel
044-589-8100
health-innovation@kuhs.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
| 2024 | Year | 08 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 27 | Day |
Last modified on
| 2024 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063225
