Clinical trial NCT04730817: VR Motor-cognitive Training for Older People With Cognitive Frailty
Official title: Virtual Reality Motor-cognitive Training for Older People With Cognitive Frailty: The Implementation of the Prototype
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Frailty
Physical Function
Keywords: Cognitive Frailty
Motor-Cognitive Training
Virtual Reality
Gamification
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Pok Oi Hospital
First posted: 2021-01-29
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Global cognitive function
timeFrame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
measure: Frailty
timeFrame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Secondary outcomes:
measure: Inhibition of cognitive interference
timeFrame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
measure: Executive function
timeFrame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
measure: Verbal and visuo-spatial short-term memory
timeFrame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
measure: Walking speed
timeFrame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
measure: Hand grip strength
timeFrame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Pok Oi Hospital Chan Shi Sau Memorial Social Service Centre
city: Lai Chi Kok
country: Hong Kong
facility: Pok Oi Hospital Mei Foo Lai Wan Kaifong Association Mr. and Mrs. Leung Chi Chim Elderly Health Support and Learning Centre
city: Lai Chi Kok
country: Hong Kong
facility: Pok Oi Hospital Mr. Kwok Hing Kwan Neighbourhood Elderly Centre
city: Tin Shui Wai
country: Hong Kong
facility: Pok Oi Hospital Chan Ping Memorial Neighbourhood Elderly Centre
city: Tuen Mun
country: Hong Kong
facility: Pok Oi Hospital Wong Muk Fung Memorial Elderly Health Support and Learning Centre
city: Yuen Long
country: Hong Kong
facility: Pok Oi Hospital Mrs. Wong Tung Yuen District Elderly Community Centre
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Rick Kwan, Dr
role: PRINCIPAL_INVESTIGATOR
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