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VR Motor-cognitive Training for Older People With Cognitive Frailty

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ClinicalTrials.gov Identifier: NCT04730817
Recruitment Status : Not yet recruiting
First Posted : January 29, 2021
Last Update Posted : January 29, 2021
Sponsor:
Collaborator:
Pok Oi Hospital
Information provided by (Responsible Party):
Dr Rick Kwan, The Hong Kong Polytechnic University

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.


Condition or disease Intervention/treatment Phase
Cognitive Frailty Physical Function Device: Virtual Reality Motor-Cognitive Training System Not Applicable

Detailed Description:
In the intervention, VR will be employed to simulate a daily living environment familiar to older people. Participants will wear a commercially available head-mounted VR system with hand-held controllers to experience the participation of daily activities in a virtual environment. Simultaneous physical and cognitive training will be embedded in the training system to promote optimal function. Participants will attend physical training in a sitting position through cycling on an ergometer and moving the hand-held controllers. Motion sensors built into the VR system and ergometer will track these movements to control everyday tasks in the virtual environment (e.g., moving around the city). Simultaneously, participants will undergo cognitive training by participating in various tasks demanding cognitive functions, such as visual-spatial (e.g., wayfinding) and problem-solving (e.g., wallet loss) functions. Gamification will be employed to promote the motivation to participate. All training activities will be gamified by blending in fun elements, such as difficulty-levelling, competition, and e-tokens. Co-participation is allowed to promote interpersonal interactions. The prototype enables real-time co-viewing among participants. Other elderly centre members and the activity facilitators can share the view of the participants in the game on either a large-screen monitor or a tablet computer, allowing them to simultaneously discuss and share about their gaming experiences.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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

Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessors at both pre- and post-observations will be blinded to the group label.
Primary Purpose: Treatment
Official Title: Virtual Reality Motor-cognitive Training for Older People With Cognitive Frailty: The Implementation of the Prototype
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Intervention group
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
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.

No Intervention: Control group
This arm will not be given any kind of treatment and will act as a passive control group.



Primary Outcome Measures :
  1. Global cognitive function [ Time Frame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart ]
    Score on the Montreal Cognitive Assessment Hong Kong Version (HK-MoCA), ranging from 0 to 30.

  2. Frailty [ Time Frame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart ]
    Score on the Fried Frailty Phenotype, ranging from 0 to 5


Secondary Outcome Measures :
  1. Inhibition of cognitive interference [ Time Frame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart ]
    Stroop Color-Word Test (SCWT) Global Index score, calculated by I=CW-((W+C)/2)

  2. Executive function [ Time Frame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart ]
    Time taken to complete the trail making test (TMA & TMB), ranges from 0 to 300 seconds (when maximum time is reached)

  3. Verbal and visuo-spatial short-term memory [ Time Frame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart ]
    Score on the Digit Span Test, ranges from 0 to 9

  4. Walking speed [ Time Frame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart ]
    Timed up and go test (seconds)

  5. Hand grip strength [ Time Frame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart ]
    Hand grip strength by dynamometer (kg)



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04730817


Contacts
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Contact: Rick Kwan, Dr (852) 2766 ext 6546 rick.kwan@polyu.edu.hk
Contact: Justina Liu, Dr (852) 2766 ext 4097 justina.liu@polyu.edu.hk

Locations
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Hong Kong
Pok Oi Hospital Chan Shi Sau Memorial Social Service Centre
Hong Kong, Hong Kong
Contact: Thomas Tsang    29848018    csssm@pokoi.org.hk   
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
Contact: Kaman Chung    2310 4848    lccwsa@pokoi.org.hk   
Pok Oi Hospital Mr. Kwok Hing Kwan Neighbourhood Elderly Centre
Lai Chi Kok, Hong Kong
Contact: Olive Sin    36146402    khkic@pokoi.org.hk   
Pok Oi Hospital Chan Ping Memorial Neighbourhood Elderly Centre
Tin Shui Wai, Hong Kong
Contact: Mandy Wong    24781930    cpaic@pokoi.org.hk   
Pok Oi Hospital Wong Muk Fung Memorial Elderly Health Support and Learning Centre
Tuen Mun, Hong Kong
Contact: Shane WL Siauw    25650877    wmfswa1@pokoi.org.hk   
Pok Oi Hospital Mrs. Wong Tung Yuen District Elderly Community Centre
Yuen Long, Hong Kong
Contact: Lai Yung Tong    2476 2227    wtysswa1@pokoi.org.hk   
Sponsors and Collaborators
The Hong Kong Polytechnic University
Pok Oi Hospital
Investigators
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Principal Investigator: Rick Kwan, Dr The Hong Kong Polytechnic University
Publications:
Tong AYC, Man DWK. The Validation of the Hong Kong Chinese Version of the Lawton Instrumental Activities of Daily Living Scale for Institutionalized Elderly Persons. OTJR: Occupation, Participation and Health. 2002; 22(4): 132-142.
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.

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Responsible Party: Dr Rick Kwan, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT04730817    
Other Study ID Numbers: K-ZB1H
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Rick Kwan, The Hong Kong Polytechnic University:
Cognitive Frailty
Motor-Cognitive Training
Virtual Reality
Gamification
Additional relevant MeSH terms:
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Frailty
Pathologic Processes