VR Motor-cognitive Training for Cognitive Frailty

Cognitive Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04467216
• Other study ID #: ZB1H
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2021
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 31, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Frailty
• Frailty

Intervention

Device:
• Computerised cognitive training using virtual reality
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.

Locations

Country	Name	City	State
Hong Kong	Pok Oi Hospital Neighbourhood Elderly Centre	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (10)

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Desjardins-Crépeau L, Berryman N, Fraser SA, Vu TT, Kergoat MJ, Li KZ, Bosquet L, Bherer L. Effects of combined physical and cognitive training on fitness and neuropsychological outcomes in healthy older adults. Clin Interv Aging. 2016 Sep 19;11:1287-1299. eCollection 2016. — View Citation

Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. — View Citation

Kelaiditi E, Cesari M, Canevelli M, van Kan GA, Ousset PJ, Gillette-Guyonnet S, Ritz P, Duveau F, Soto ME, Provencher V, Nourhashemi F, Salvà A, Robert P, Andrieu S, Rolland Y, Touchon J, Fitten JL, Vellas B; IANA/IAGG. Cognitive frailty: rational and definition from an (I.A.N.A./I.A.G.G.) international consensus group. J Nutr Health Aging. 2013 Sep;17(9):726-34. doi: 10.1007/s12603-013-0367-2. — View Citation

Lauenroth A, Ioannidis AE, Teichmann B. Influence of combined physical and cognitive training on cognition: a systematic review. BMC Geriatr. 2016 Jul 18;16:141. doi: 10.1186/s12877-016-0315-1. Review. — View Citation

Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. Erratum in: J Am Geriatr Soc. 2019 Sep;67(9):1991. — View Citation

Rosanna Chau MW, Chan SP, Wong YW, Lau MYP. Reliability and validity of the Modified Functional Ambulation Classification in patients with hip fracture. Hong Kong Physiotherapy Journal. 2013;31(1):41-44.

Ruan Q, Yu Z, Chen M, Bao Z, Li J, He W. Cognitive frailty, a novel target for the prevention of elderly dependency. Ageing Res Rev. 2015 Mar;20:1-10. doi: 10.1016/j.arr.2014.12.004. Epub 2014 Dec 30. Review. — View Citation

Tait JL, Duckham RL, Milte CM, Main LC, Daly RM. Influence of Sequential vs. Simultaneous Dual-Task Exercise Training on Cognitive Function in Older Adults. Front Aging Neurosci. 2017 Nov 7;9:368. doi: 10.3389/fnagi.2017.00368. eCollection 2017. Review. — View Citation

Yeung PY, Wong LL, Chan CC, Leung JL, Yung CY. A validation study of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) in Chinese older adults in Hong Kong. Hong Kong Med J. 2014 Dec;20(6):504-10. doi: 10.12809/hkmj144219. Epub 2014 Aug 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Primary	Selective attention	Stroop test (score)	Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Primary	Visual-spatial perception	Visual Object Space Perception test (score)	Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Secondary	Frailty	Fried Frailty Phenotype (score)	Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Secondary	Walking	Timed up and go test (seconds)	Change is being assessed: "baseline" and "immediately after the completion" (2 months)
Secondary	Strength	Grip strength by dynamometer (kg)	Change is being assessed: "baseline" and "immediately after the completion" (2 months)