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OpenTrials
Completed

NCT Number: NCT04467216

VR Motor-cognitive Training for Cognitive Frailty

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.

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pok Oi Hospital Neighbourhood Elderly Centre

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 60 years,
  • 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
  • Cognitive frailty, as defined by co-existence of mild cognitive impairment and physical frailty,
  • Mild cognitive impairment, measured by Montreal Cognitive Assessment (MoCA) ≤ 25 and Clinical Dementia Rating (CDR) = 0.5, and
  • Frailty status from pre-frail to frail, measured by Fried Frailty Phenotype score ≥ 1.

Exclusion criteria

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

Treatment and study plan

Computerised cognitive training using virtual reality

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 systems available in the market for older people are only for non-interactive activities (e.g., watching movies) to provide unusual experiences for disabled older people who cannot travel too far from home.

Primary outcomes

  1. Global cognitive function

    Time frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)

    Montreal Cognitive Assessment (score), scores on the MoCA range from zero to 30.

    With a score of 26 and higher generally considered normal, with 25 to 18 are considered Mild Cognitive Impairment and with score lower then 18 are defined as Alzheimer's disease.

  2. Selective attention

    Time frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)

    Stroop test (score)

  3. Visual-spatial perception

    Time frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)

    Visual Object Space Perception test (score)

Secondary outcomes

  1. Frailty

    Time frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)

    Fried Frailty Phenotype (score)

  2. Walking

    Time frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)

    Timed up and go test (seconds)

  3. Strength

    Time frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)

    Grip strength by dynamometer (kg)

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Virtual Reality Motor-cognitive Training for Older People With Cognitive Frailty: A Pilot Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 10, 2020
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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