VR Motor-cognitive Training for Older People With Cognitive Frailty

NCT04730817 | Unknown

• 1 other identifier: K-ZB1H
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 6

Brief Summary

Cognitive frailty is a clinical syndrome in which cognitive impairment (e.g., poor memory, visuospatial function) and physical frailty (e.g., slowness, poor muscle strength, physical inactivity) co-exist. It is prevalent in community-dwelling older people. The progressive decline of cognitive and physical functions restricts older people from participating in activities (e.g., social get-togethers). Reduced participation further jeopardizes their life-space mobility (e.g., ability to travel to areas far away from home). Therefore, those with cognitive frailty are at risk of developing dementia and becoming dependent. Simultaneous motor-cognitive training is more effective at promoting optimal functioning in older people than motor or cognitive training alone. Gaming is effective at promoting the motivation to participate. The contents of games in the market are unrelated to the context or daily living of the elderly. Currently, available training is non-simultaneous. This makes the training less transferable to the daily life of the elderly and reduces its effects. Virtual reality (VR) technology can provide a virtual space that mimics the real environment. This allows clients to participate in daily activities in a virtual space. Older people can be trained to improve their cognitive and physical skills in a painless, fun way. However, the effect and feasibility of employing simultaneous motor-cognitive training launching on a VR platform mimicking the daily living environment in older people with cognitive frailty is poorly known. Following the findings from the previous proof-of-concept test (registration number: NCT04467216), we proceed to implement the study to 400 participants from six different elderly centres between the period of March 2021 and December 2022.

Conditions

Cognitive Frailty; Physical Function

Keywords

Cognitive Frailty; Motor-Cognitive Training; Virtual Reality; Gamification

Outcome Measures

Primary Outcomes (2)

• Global cognitive function

  Score on the Montreal Cognitive Assessment Hong Kong Version (HK-MoCA), ranging from 0 to 30.

  Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

• Frailty

  Score on the Fried Frailty Phenotype, ranging from 0 to 5

  Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

Secondary Outcomes (5)

• Inhibition of cognitive interference

  Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

• Executive function

  Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

• Verbal and visuo-spatial short-term memory

  Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

• Walking speed

  Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

• Hand grip strength

  Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

Study Arms (2)

Intervention group

EXPERIMENTAL

This arm will undertake VR simultaneous motor-cognitive training in 30 minutes session, twice a week for 8 weeks.

Device: Virtual Reality Motor-Cognitive Training System

Control group

NO INTERVENTION

This arm will not be given any kind of treatment and will act as a passive control group.

Interventions

Virtual Reality Motor-Cognitive Training System DEVICE

Immersive VR training system tailor-made for the daily living experiences in the Hong Kong context to provide interactive experiences for older people in Hong Kong. The VR training system is designed as a game with 16 progressive levels (anticipating intervention group participants to complete 2 levels per week for 8 weeks) which aim to train their motor and cognitive functions.

Intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 60 years,
• Self-reported or informant-reported cognitive complaints
• Objective cognitive impairment, as defined by a Clinical Dementia Rating of 0.5 and a Montreal Cognitive Assessment (MoCA) score of \<25
• Preservation of one's independence, as defined by the Lawton's Instrumental Activity of Daily Living score of \>14
• No diagnosed dementia, as observed in the medical record
• Physical frailty from being pre-frail to frail, as defined by a Fried Frailty Index (FFI) score of 1-5.

You may not qualify if:

• Participants who have impaired mobility, as defined by Modified Functional Ambulatory Classification (MFAC) \< Category 7 (i.e., Outdoor walker),
• or probable dementia, i.e., MoCA \< 17 or clinical dementia rating ≥ 1.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Pok Oi Hospital: collaborator

Study Sites (6)

Pok Oi Hospital Chan Shi Sau Memorial Social Service Centre

Hong Kong, Hong Kong

RECRUITING

Pok Oi Hospital Mei Foo Lai Wan Kaifong Association Mr. and Mrs. Leung Chi Chim Elderly Health Support and Learning Centre

Lai Chi Kok, Hong Kong

RECRUITING

Pok Oi Hospital Mr. Kwok Hing Kwan Neighbourhood Elderly Centre

Lai Chi Kok, Hong Kong

RECRUITING

Pok Oi Hospital Chan Ping Memorial Neighbourhood Elderly Centre

Tin Shui Wai, Hong Kong

RECRUITING

Pok Oi Hospital Wong Muk Fung Memorial Elderly Health Support and Learning Centre

Tuenmen, Hong Kong

RECRUITING

Pok Oi Hospital Mrs. Wong Tung Yuen District Elderly Community Centre

Yuen Long, Hong Kong

RECRUITING

Related Publications (19)

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  BACKGROUND

• Chau MWR, Chan SP, Wong YW, Lau MYP. Reliability and validity of the Modified Functional Ambulation Classification in patients with hip fracture. Hong Kong Physiotherapy Journal. 2013; 31(1): 41-44.

  BACKGROUND

• Kwan RYC, Liu J, Sin OSK, Fong KNK, Qin J, Wong JCY, Lai C. Effects of Virtual Reality Motor-Cognitive Training for Older People With Cognitive Frailty: Multicentered Randomized Controlled Trial. J Med Internet Res. 2024 Sep 11;26:e57809. doi: 10.2196/57809.

  PMID: 39259959 DERIVED

Study Officials

• Rick Kwan, Dr

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rick Kwan, Dr

CONTACT

(852) 2766; rick.kwan@polyu.edu.hk

Justina Liu, Dr

CONTACT

(852) 2766; justina.liu@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors at both pre- and post-observations will be blinded to the group label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A total of 400 subjects with cognitive frailty will be assigned into 2 groups. Half the participants will be assigned to the intervention group in which they will undertake VR simultaneous motor-cognitive training and others will be assigned to the control group in the form of passive (wait list) control, i.e., they will not be given any kind of treatment. The following dosage will be employed onto the intervention group using the VR simultaneous motor-cognitive training that we proposed. I.e., Course: eight weeks Session duration: 30 minutes Frequency: twice per week

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: March 1, 2021
• Primary Completion: May 31, 2021
• Study Completion: December 1, 2022
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (6)