Clinical trial NCT04467216: VR Motor-cognitive Training for Cognitive Frailty
Official title: Virtual Reality Motor-cognitive Training for Older People With Cognitive Frailty: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Frailty
Keywords: Cognitive frailty
Motor-cognitive training
Virtual reality
Gamification
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 17
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 16 subjects with cognitive frailty will be assigned into 2 groups. Eight participants will be assigned to the intervention group in which they will undertake VR simultaneous motor-cognitive training and eight participants will be assigned to the control group in which existing forms of non-VR sequential motor-cognitive training will be provided.

Both intervention and control groups will employ the same intervention dosage including course, session duration and frequency. The following dosage is employed because they are also the same dosage used in 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. This pilot trial aims to examine the preliminary effects on cognitive function and frailty syndrome, as well as examine the feasibility.

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. They can simultaneously talk about and share their gaming experiences.

Eligibility criteria: Inclusion criteria

1. Age ≥ 60 years,
2. Community dwelling, as defined by living at home without staying in long-term care facilities (e.g., nursing home) in the last 12 months, and
3. Cognitive frailty, as defined by co-existence of mild cognitive impairment and physical frailty,

   1. Mild cognitive impairment, measured by Montreal Cognitive Assessment (MoCA) ≤ 25 and Clinical Dementia Rating (CDR) = 0.5, and
   2. Frailty status from pre-frail to frail, measured by Fried Frailty Phenotype score ≥ 1.

Exclusion criteria

1. Diagnosed dementia, according to subjects' medical record, or
2. Probable dementia, as defined by MoCA ≤ 18, or
3. Mobility restriction, as defined by Modified Functional Ambulatory Classification (MFAC) \< Category 7 (i.e., Outdoor walker), or

Primary outcomes:
measure: Global cognitive function
timeFrame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
measure: Selective attention
timeFrame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
measure: Visual-spatial perception
timeFrame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Secondary outcomes:
measure: Frailty
timeFrame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
measure: Walking
timeFrame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
measure: Strength
timeFrame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Pok Oi Hospital Neighbourhood Elderly Centre
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Rick Kwan
role: STUDY_CHAIR
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