UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000052750
Receipt number R000060136
Scientific Title Experiment on the effect of preventing nursing care on elderly people using e-sports
Date of disclosure of the study information 2023/11/09
Last modified on 2023/11/09 19:55:38

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Basic information

Public title

Effects of e-sports on nursing care prevention

Acronym

E-sports on care prevention

Scientific Title

Experiment on the effect of preventing nursing care on elderly people using e-sports

Scientific Title:Acronym

Elderly care prevention through e-sports

Region

Japan


Condition

Condition

Healthy elderly

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of increasing the frequency and number of esports events on cognitive function, etc.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

MOCA-J (Japanese version of Montreal Cognitive Assessment)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

n-of-1

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Play a video game five times a week for one hour each time for five weeks.

Interventions/Control_2


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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Residents of Misato Town, Kumamoto Prefecture, who are independent in their daily lives and have not been diagnosed with dementia, and who consented to this study.

Key exclusion criteria

Those with epilepsy, those who cannot maintain a sitting position, and those with impaired visual or finger function.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Kubo
Middle name
Last name Takaaki

Organization

Kumamoto Health Science University

Division name

Faculty of Health Sciences

Zip code

8615598

Address

325 Izumi-machi, Kita-ku, Kumamoto

TEL

096-275-2111

Email

kubo@kumamoto-hsu.ac.jp


Public contact

Name of contact person

1st name Kubo
Middle name
Last name Takaaki

Organization

Kumamoto Health Science University

Division name

Faculty of Health Sciences

Zip code

8615598

Address

325 Izumi-machi, Kita-ku, Kumamoto

TEL

096-275-2111

Homepage URL


Email

kubo@kumamoto-hsu.ac.jp


Sponsor or person

Institute

Kumamoto Health Science University

Institute

Department

Personal name



Funding Source

Organization

Kumamoto Prefectural Office

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kumamoto University of Health Science Life Science Ethics Review Committee

Address

325 Izumi-machi, Kita-ku, Kumamoto

Tel

0962752112

Email

kikaku@kumamoto-hsu.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 11 Month 09 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

Preinitiation

Date of protocol fixation

2023 Year 11 Month 09 Day

Date of IRB


Anticipated trial start date

2023 Year 11 Month 09 Day

Last follow-up date

2025 Year 03 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 11 Month 09 Day

Last modified on

2023 Year 11 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060136


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name