UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000055778
Receipt number R000063747
Scientific Title Effects of Virtual Reality-Based Smart Multi-Program on Cognitive and Physical Functions in Older Adults
Date of disclosure of the study information 2024/10/30
Last modified on 2024/10/08 12:48:35

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Basic information

Public title

Effects of Virtual Reality-Based Smart Multi-Program on Cognitive and Physical Functions in Older Adults

Acronym

Effects of Virtual Reality-Based Smart Multi-Program on Cognitive and Physical Functions in Older Adults

Scientific Title

Effects of Virtual Reality-Based Smart Multi-Program on Cognitive and Physical Functions in Older Adults

Scientific Title:Acronym

Effects of Virtual Reality-Based Smart Multi-Program on Cognitive and Physical Functions in Older Adults

Region

Asia(except Japan)


Condition

Condition

N/A

Classification by specialty

Geriatrics Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to develop a VR-based combined training program tailored to the characteristics of older adults, implement the program for them, and verify its effectiveness in improving cognitive and physical functions.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

K-MMSE (Korean Mini-Mental State Examination),Grip strength, bio-impedence

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants 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

Other

Interventions/Control_1

The VR-based combined training program will be conducted twice a week, for 30 minutes per session, over a total period of 16 weeks.

Interventions/Control_2

Participants are instructed to maintain their usual daily activities, and a brochure on cognitive and physical function exercises will be provided.

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

Individuals who understand the purpose of this study and have voluntarily provided written consent.

Key exclusion criteria

1) Individuals with untreated severe medical conditions, 2) Individuals with severe musculoskeletal or neurological conditions accompanied by uncontrolled pain, 3) Individuals with difficulty walking independently, 4) Individuals deemed unsuitable for study participation by the researcher due to other reasons (such as cognitive decline, functional impairment).

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Yeong-Ae
Middle name
Last name Yang

Organization

Inje University

Division name

Department of Occupational Therapy, College of Biomedical Science and Engineering

Zip code

50834

Address

197, Inje-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea

TEL

82553203686

Email

otyya62@inje.ac.kr


Public contact

Name of contact person

1st name Duri
Middle name
Last name Kim

Organization

Pusan National University Hospital

Division name

Health Convergence Medicine Laboratory

Zip code

49241

Address

179, Gudeok-ro, Seo-gu, Busan, Republic of Korea

TEL

821022994100

Homepage URL


Email

drkim4100@gmail.com


Sponsor or person

Institute

Inje University

Institute

Department

Personal name



Funding Source

Organization

the National Research Foundation (NRF) funded by the Korean government (MSIT).

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

Inje University

Address

197, Inje-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea

Tel

821022994100

Email

drkim4100@gmail.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

2024 Year 10 Month 30 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

60

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

2023 Year 03 Month 01 Day

Date of IRB

2023 Year 08 Month 22 Day

Anticipated trial start date

2023 Year 09 Month 01 Day

Last follow-up date

2024 Year 10 Month 30 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 10 Month 08 Day

Last modified on

2024 Year 10 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063747


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name