VR Motor-cognitive Training for Older People With Cognitive Frailty

NCT ID: NCT04730817

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-12-31

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.

Following the findings from the previous proof-of-concept test (registration number: NCT04467216), we proceed to implement the study to 400 participants from six different elderly centres between the period of March 2021 and December 2022.

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, allowing them to simultaneously discuss and share about their gaming experiences.

Conditions

Cognitive Frailty; Physical Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Virtual Reality Motor-Cognitive Training System

Intervention Type: 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 training system is designed as a game with 16 progressive levels (anticipating intervention group participants to complete 2 levels per week for 8 weeks) which aim to train their motor and cognitive functions.

Control group

This arm will not be given any kind of treatment and will act as a passive control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality Motor-Cognitive Training System

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 training system is designed as a game with 16 progressive levels (anticipating intervention group participants to complete 2 levels per week for 8 weeks) which aim to train their motor and cognitive functions.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 60 years,
• Self-reported or informant-reported cognitive complaints
• Objective cognitive impairment, as defined by a Clinical Dementia Rating of 0.5 and a Montreal Cognitive Assessment (MoCA) score of <25
• Preservation of one's independence, as defined by the Lawton's Instrumental Activity of Daily Living score of >14
• No diagnosed dementia, as observed in the medical record
• Physical frailty from being pre-frail to frail, as defined by a Fried Frailty Index (FFI) score of 1-5.

Exclusion Criteria

• Participants who have impaired mobility, as defined by Modified Functional Ambulatory Classification (MFAC) < Category 7 (i.e., Outdoor walker),
• or probable dementia, i.e., MoCA < 17 or clinical dementia rating ≥ 1.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pok Oi Hospital

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr Rick Kwan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rick Kwan, Dr

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

Pok Oi Hospital Chan Shi Sau Memorial Social Service Centre

Hong Kong, , Hong Kong

Site Status: RECRUITING

Pok Oi Hospital Mei Foo Lai Wan Kaifong Association Mr. and Mrs. Leung Chi Chim Elderly Health Support and Learning Centre

Lai Chi Kok, , Hong Kong

Site Status: RECRUITING

Pok Oi Hospital Mr. Kwok Hing Kwan Neighbourhood Elderly Centre

Lai Chi Kok, , Hong Kong

Site Status: RECRUITING

Pok Oi Hospital Chan Ping Memorial Neighbourhood Elderly Centre

Tin Shui Wai, , Hong Kong

Site Status: RECRUITING

Pok Oi Hospital Wong Muk Fung Memorial Elderly Health Support and Learning Centre

Tuenmen, , Hong Kong

Site Status: RECRUITING

Pok Oi Hospital Mrs. Wong Tung Yuen District Elderly Community Centre

Yuen Long, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Rick Kwan, Dr

Role: CONTACT

rick.kwan@polyu.edu.hk

(852) 2766 ext. 6546

Justina Liu, Dr

Role: CONTACT

justina.liu@polyu.edu.hk

(852) 2766 ext. 4097

Facility Contacts

Thomas Tsang

Role: primary

csssm@pokoi.org.hk

29848018

Kaman Chung

Role: primary

lccwsa@pokoi.org.hk

2310 4848

Olive Sin

Role: primary

khkic@pokoi.org.hk

36146402

Mandy Wong

Role: primary

cpaic@pokoi.org.hk

24781930

Shane WL Siauw

Role: primary

wmfswa1@pokoi.org.hk

25650877

Lai Yung Tong

Role: primary

wtysswa1@pokoi.org.hk

2476 2227

References

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.

Reference Type: BACKGROUND

PMID: 25555677 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15817019 (View on PubMed)

Wong A, Xiong YY, Kwan PW, Chan AY, Lam WW, Wang K, Chu WC, Nyenhuis DL, Nasreddine Z, Wong LK, Mok VC. The validity, reliability and clinical utility of the Hong Kong Montreal Cognitive Assessment (HK-MoCA) in patients with cerebral small vessel disease. Dement Geriatr Cogn Disord. 2009;28(1):81-7. doi: 10.1159/000232589. Epub 2009 Aug 11.

Reference Type: BACKGROUND

PMID: 19672065 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25125421 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11253156 (View on PubMed)

Viosca E, Martinez JL, Almagro PL, Gracia A, Gonzalez C. Proposal and validation of a new functional ambulation classification scale for clinical use. Arch Phys Med Rehabil. 2005 Jun;86(6):1234-8. doi: 10.1016/j.apmr.2004.11.016.

Reference Type: BACKGROUND

PMID: 15954065 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24154642 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27698558 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27431673 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29163146 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29028622 (View on PubMed)

Scarpina F, Tagini S. The Stroop Color and Word Test. Front Psychol. 2017 Apr 12;8:557. doi: 10.3389/fpsyg.2017.00557. eCollection 2017.

Reference Type: BACKGROUND

PMID: 28446889 (View on PubMed)

Monaco M, Costa A, Caltagirone C, Carlesimo GA. Forward and backward span for verbal and visuo-spatial data: standardization and normative data from an Italian adult population. Neurol Sci. 2013 May;34(5):749-54. doi: 10.1007/s10072-012-1130-x. Epub 2012 Jun 12.

Reference Type: BACKGROUND

PMID: 22689311 (View on PubMed)

Wei M, Shi J, Li T, Ni J, Zhang X, Li Y, Kang S, Ma F, Xie H, Qin B, Fan D, Zhang L, Wang Y, Tian J. Diagnostic Accuracy of the Chinese Version of the Trail-Making Test for Screening Cognitive Impairment. J Am Geriatr Soc. 2018 Jan;66(1):92-99. doi: 10.1111/jgs.15135. Epub 2017 Nov 14.

Reference Type: BACKGROUND

PMID: 29135021 (View on PubMed)

Freitas S, Simoes MR, Alves L, Santana I. Montreal cognitive assessment: validation study for mild cognitive impairment and Alzheimer disease. Alzheimer Dis Assoc Disord. 2013 Jan-Mar;27(1):37-43. doi: 10.1097/WAD.0b013e3182420bfe.

Reference Type: BACKGROUND

PMID: 22193353 (View on PubMed)

Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.

Reference Type: BACKGROUND

PMID: 5349366 (View on PubMed)

Tong AYC, Man DWK. The Validation of the Hong Kong Chinese Version of the Lawton Instrumental Activities of Daily Living Scale for Institutionalized Elderly Persons. OTJR: Occupation, Participation and Health. 2002; 22(4): 132-142.

Reference Type: BACKGROUND

Chau MWR, 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.

Reference Type: BACKGROUND

Kwan RYC, Liu J, Sin OSK, Fong KNK, Qin J, Wong JCY, Lai C. Effects of Virtual Reality Motor-Cognitive Training for Older People With Cognitive Frailty: Multicentered Randomized Controlled Trial. J Med Internet Res. 2024 Sep 11;26:e57809. doi: 10.2196/57809.

Reference Type: DERIVED

PMID: 39259959 (View on PubMed)

Other Identifiers

K-ZB1H

Identifier Type: -

Identifier Source: org_study_id