VR Motor-cognitive Training for Cognitive Frailty
Primary Purpose
Cognitive Frailty
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Computerised cognitive training using virtual reality
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Frailty focused on measuring Cognitive frailty, Motor-cognitive training, Virtual reality, Gamification
Eligibility Criteria
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
Sites / Locations
- Pok Oi Hospital Neighbourhood Elderly Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control Group
Arm Description
This arm will undertake VR simultaneous motor-cognitive training in 30 minutes session, twice a week for 8 weeks
This arm will be doing existing forms of motor-cognitive training in 30 minutes session, twice a week for 8 weeks
Outcomes
Primary Outcome Measures
Global cognitive function
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.
Selective attention
Stroop test (score)
Visual-spatial perception
Visual Object Space Perception test (score)
Secondary Outcome Measures
Frailty
Fried Frailty Phenotype (score)
Walking
Timed up and go test (seconds)
Strength
Grip strength by dynamometer (kg)
Full Information
NCT ID
NCT04467216
First Posted
June 11, 2020
Last Updated
August 23, 2021
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT04467216
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Frailty
Keywords
Cognitive frailty, Motor-cognitive training, Virtual reality, Gamification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Outcomes Assessor
Masking Description
Outcome assessors at both pre- and post-observations will be blinded to the group label
Allocation
Non-Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
This arm will undertake VR simultaneous motor-cognitive training in 30 minutes session, twice a week for 8 weeks
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This arm will be doing existing forms of motor-cognitive training in 30 minutes session, twice a week for 8 weeks
Intervention Type
Device
Intervention Name(s)
Computerised cognitive training using virtual reality
Intervention Description
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 Outcome Measure Information:
Title
Global cognitive function
Description
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.
Time Frame
Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Title
Selective attention
Description
Stroop test (score)
Time Frame
Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Title
Visual-spatial perception
Description
Visual Object Space Perception test (score)
Time Frame
Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Secondary Outcome Measure Information:
Title
Frailty
Description
Fried Frailty Phenotype (score)
Time Frame
Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Title
Walking
Description
Timed up and go test (seconds)
Time Frame
Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Title
Strength
Description
Grip strength by dynamometer (kg)
Time Frame
Change is being assessed: "baseline" and "immediately after the completion" (2 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rick Kwan
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Study Chair
Facility Information:
Facility Name
Pok Oi Hospital Neighbourhood Elderly Centre
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Citation
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VR Motor-cognitive Training for Cognitive Frailty
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