VR Motor-cognitive Training for Cognitive Frailty

August 23, 2021 updated by: Dr Rick Kwan, The Hong Kong Polytechnic University

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, Hong Kong
        • Pok Oi Hospital Neighbourhood Elderly Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
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.
No Intervention: Control Group
This arm will be doing existing forms of motor-cognitive training in 30 minutes session, twice a week for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Selective attention
Time Frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Stroop test (score)
Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Visual-spatial perception
Time Frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Visual Object Space Perception test (score)
Change is being assessed: "baseline" and "immediately after the completion" (2 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty
Time Frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Fried Frailty Phenotype (score)
Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Walking
Time Frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Timed up and go test (seconds)
Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Strength
Time Frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Grip strength by dynamometer (kg)
Change is being assessed: "baseline" and "immediately after the completion" (2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Rick Kwan, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2020

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

July 8, 2020

First Posted (Actual)

July 10, 2020

Study Record Updates

Last Update Posted (Actual)

August 27, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZB1H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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