VR Motor-cognitive Training for Cognitive Frailty

NCT04467216 | Completed

• 1 other identifier: ZB1H
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Frailty

Keywords

Cognitive frailty; Motor-cognitive training; Virtual reality; Gamification

Outcome Measures

Primary Outcomes (3)

• 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)

• Selective attention

  Stroop test (score)

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

• Visual-spatial perception

  Visual Object Space Perception test (score)

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

Secondary Outcomes (3)

• Frailty

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

• Walking

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

• Strength

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

Study Arms (2)

Intervention group

EXPERIMENTAL

This arm will undertake VR simultaneous motor-cognitive training in 30 minutes session, twice a week for 8 weeks

Device: Computerised cognitive training using virtual reality

Control Group

NO INTERVENTION

This arm will be doing existing forms of motor-cognitive training in 30 minutes session, twice a week for 8 weeks

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Pok Oi Hospital Neighbourhood Elderly Centre

Hong Kong, Hong Kong

Location

Related Publications (11)

• 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.

  PMID: 25555677 BACKGROUND

• Nasreddine ZS, Phillips NA, Bedirian 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. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 BACKGROUND

• 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.

  PMID: 25125421 BACKGROUND

• 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. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

• 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.

  BACKGROUND

• Kelaiditi E, Cesari M, Canevelli M, van Kan GA, Ousset PJ, Gillette-Guyonnet S, Ritz P, Duveau F, Soto ME, Provencher V, Nourhashemi F, Salva 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.

  PMID: 24154642 BACKGROUND

• Desjardins-Crepeau 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. doi: 10.2147/cia.s115711. eCollection 2016.

  PMID: 27698558 BACKGROUND

• 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.

  PMID: 27431673 BACKGROUND

• 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.

  PMID: 29163146 BACKGROUND

• de Vries AW, Faber G, Jonkers I, Van Dieen JH, Verschueren SMP. Virtual reality balance training for elderly: Similar skiing games elicit different challenges in balance training. Gait Posture. 2018 Jan;59:111-116. doi: 10.1016/j.gaitpost.2017.10.006. Epub 2017 Oct 5.

  PMID: 29028622 BACKGROUND

• Kwan RYC, Liu JYW, Fong KNK, Qin J, Leung PK, Sin OSK, Hon PY, Suen LW, Tse MK, Lai CK. Feasibility and Effects of Virtual Reality Motor-Cognitive Training in Community-Dwelling Older People With Cognitive Frailty: Pilot Randomized Controlled Trial. JMIR Serious Games. 2021 Aug 6;9(3):e28400. doi: 10.2196/28400.

  PMID: 34383662 DERIVED

Study Officials

• Rick Kwan

  The Hong Kong Polytechnic University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors at both pre- and post-observations will be blinded to the group label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: July 10, 2020
• Study Start: July 15, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2020
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)