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Cognitive FrailtyNCT04730817

VR Motor-cognitive Training for Older People With Cognitive Frailty

A study testing Virtual Reality Motor-Cognitive Training System in people with Cognitive Frailty and Physical Function, run by The Hong Kong Polytechnic University at 6 sites in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Cognitive Frailty, Physical Function
What is being tested?
Virtual Reality Motor-Cognitive Training System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
6 sitesHong Kong
Study dates
1 Mar 2021to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

Rick Kwan, Dr contact

(852) 2766 ext. 6546

rick.kwan@polyu.edu.hk

Justina Liu, Dr contact

(852) 2766 ext. 4097

justina.liu@polyu.edu.hk

6 sites in 1 country

Hong Kong6 sites, 6 recruiting

  • Pok Oi Hospital Chan Shi Sau Memorial Social Service Centre

    Hong Kong

    Thomas Tsang, 29848018, csssm@pokoi.org.hk

    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

    Kaman Chung, 2310 4848, lccwsa@pokoi.org.hk

    Recruiting

  • Pok Oi Hospital Mr. Kwok Hing Kwan Neighbourhood Elderly Centre

    Lai Chi Kok

    Olive Sin, 36146402, khkic@pokoi.org.hk

    Recruiting

  • Pok Oi Hospital Chan Ping Memorial Neighbourhood Elderly Centre

    Tin Shui Wai

    Mandy Wong, 24781930, cpaic@pokoi.org.hk

    Recruiting

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

    Tuenmen

    Shane WL Siauw, 25650877, wmfswa1@pokoi.org.hk

    Recruiting

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

    Yuen Long

    Lai Yung Tong, 2476 2227, wtysswa1@pokoi.org.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Virtual Reality Motor-cognitive Training for Older People With Cognitive Frailty: The Implementation of the Prototype

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.

Read more

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.

Read the 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.

Being tested
Virtual Reality Motor-Cognitive Training System
Keywords
Cognitive Frailty, Motor-Cognitive Training, Virtual Reality, Gamification

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality Motor-Cognitive Training SystemDevice

    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.

Study groups in NCT04730817
Study groupRoleWhat they receive
Intervention groupExperimentalThis arm will undertake VR simultaneous motor-cognitive training in 30 minutes session, twice a week for 8 weeks.
Receives: Device: Virtual Reality Motor-Cognitive Training System
Control groupNo interventionThis arm will not be given any kind of treatment and will act as a passive control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global cognitive function

    Score on the Montreal Cognitive Assessment Hong Kong Version (HK-MoCA), ranging from 0 to 30.

    Measured: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

  2. Frailty

    Score on the Fried Frailty Phenotype, ranging from 0 to 5

    Measured: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

Secondary outcomes (5)

  1. Inhibition of cognitive interference

    Stroop Color-Word Test (SCWT) Global Index score, calculated by I=CW-((W+C)/2)

    Measured: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

  2. Executive function

    Time taken to complete the trail making test (TMA \& TMB), ranges from 0 to 300 seconds (when maximum time is reached)

    Measured: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

  3. Verbal and visuo-spatial short-term memory

    Score on the Digit Span Test, ranges from 0 to 9

    Measured: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

  4. Walking speed

    Timed up and go test (seconds)

    Measured: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

  5. Hand grip strength

    Hand grip strength by dynamometer (kg)

    Measured: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2021
  2. Study start1 Mar 2021
  3. Primary completion31 May 2021
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A total of 400 subjects with cognitive frailty will be assigned into 2 groups. Half the participants will be assigned to the intervention group in which they will undertake VR simultaneous motor-cognitive training and others will be assigned to the control group in the form of passive (wait list) control, i.e., they will not be given any kind of treatment. The following dosage will be employed onto the intervention group using the VR simultaneous motor-cognitive training that we proposed. I.e., Course: eight weeks Session duration: 30 minutes Frequency: twice per week
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04730817
Sponsor's protocol ID
K-ZB1H
Status last verified
Aug 2021
First submitted
26 Jan 2021
Last updated
27 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25555677

  • 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.

    PubMed 15817019

  • 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.

    PubMed 19672065

  • 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.

    PubMed 25125421

  • 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.

    PubMed 11253156

  • 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.

    PubMed 15954065

  • 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.

    PubMed 24154642

  • 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.

    PubMed 27698558

  • 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.

    PubMed 27431673

  • 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.

    PubMed 29163146

  • 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.

    PubMed 29028622

  • 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.

    PubMed 28446889

  • 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.

    PubMed 22689311

  • 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.

    PubMed 29135021

  • 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.

    PubMed 22193353

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Motor-Cognitive Training System in people with Cognitive Frailty and Physical Function, run by The Hong Kong Polytechnic University at 6 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rick Kwan, Dr ((852) 2766 ext. 6546, rick.kwan@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global cognitive function (time frame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04730817, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.

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