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VR Motor-cognitive Training for Older People With Cognitive Frailty

Primary Purpose

Cognitive Frailty, Physical Function

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Virtual Reality Motor-Cognitive Training System
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pok Oi Hospital Chan Shi Sau Memorial Social Service CentreRecruiting
  • Pok Oi Hospital Mei Foo Lai Wan Kaifong Association Mr. and Mrs. Leung Chi Chim Elderly Health Support and Learning CentreRecruiting
  • Pok Oi Hospital Mr. Kwok Hing Kwan Neighbourhood Elderly CentreRecruiting
  • Pok Oi Hospital Chan Ping Memorial Neighbourhood Elderly CentreRecruiting
  • Pok Oi Hospital Wong Muk Fung Memorial Elderly Health Support and Learning CentreRecruiting
  • Pok Oi Hospital Mrs. Wong Tung Yuen District Elderly Community CentreRecruiting

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

Outcomes

Primary Outcome Measures

Global cognitive function
Score on the Montreal Cognitive Assessment Hong Kong Version (HK-MoCA), ranging from 0 to 30.
Frailty
Score on the Fried Frailty Phenotype, ranging from 0 to 5

Secondary Outcome Measures

Inhibition of cognitive interference
Stroop Color-Word Test (SCWT) Global Index score, calculated by I=CW-((W+C)/2)
Executive function
Time taken to complete the trail making test (TMA & TMB), ranges from 0 to 300 seconds (when maximum time is reached)
Verbal and visuo-spatial short-term memory
Score on the Digit Span Test, ranges from 0 to 9
Walking speed
Timed up and go test (seconds)
Hand grip strength
Hand grip strength by dynamometer (kg)

Full Information

First Posted
January 26, 2021
Last Updated
August 23, 2021
Sponsor
The Hong Kong Polytechnic University
Collaborators
Pok Oi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04730817
Brief Title
VR Motor-cognitive Training for Older People With Cognitive Frailty
Official Title
Virtual Reality Motor-cognitive Training for Older People With Cognitive Frailty: The Implementation of the Prototype
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Pok Oi Hospital

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Frailty, Physical Function
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 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
Outcomes Assessor
Masking Description
Outcome assessors at both pre- and post-observations will be blinded to the group label.
Allocation
Randomized
Enrollment
400 (Anticipated)

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 not be given any kind of treatment and will act as a passive control group.
Intervention Type
Device
Intervention Name(s)
Virtual Reality Motor-Cognitive Training System
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 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.
Primary Outcome Measure Information:
Title
Global cognitive function
Description
Score on the Montreal Cognitive Assessment Hong Kong Version (HK-MoCA), ranging from 0 to 30.
Time Frame
Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Title
Frailty
Description
Score on the Fried Frailty Phenotype, ranging from 0 to 5
Time Frame
Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Secondary Outcome Measure Information:
Title
Inhibition of cognitive interference
Description
Stroop Color-Word Test (SCWT) Global Index score, calculated by I=CW-((W+C)/2)
Time Frame
Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Title
Executive function
Description
Time taken to complete the trail making test (TMA & TMB), ranges from 0 to 300 seconds (when maximum time is reached)
Time Frame
Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Title
Verbal and visuo-spatial short-term memory
Description
Score on the Digit Span Test, ranges from 0 to 9
Time Frame
Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Title
Walking speed
Description
Timed up and go test (seconds)
Time Frame
Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Title
Hand grip strength
Description
Hand grip strength by dynamometer (kg)
Time Frame
Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rick Kwan, Dr
Phone
(852) 2766
Ext
6546
Email
rick.kwan@polyu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Justina Liu, Dr
Phone
(852) 2766
Ext
4097
Email
justina.liu@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rick Kwan, Dr
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pok Oi Hospital Chan Shi Sau Memorial Social Service Centre
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Tsang
Phone
29848018
Email
csssm@pokoi.org.hk
Facility Name
Pok Oi Hospital Mei Foo Lai Wan Kaifong Association Mr. and Mrs. Leung Chi Chim Elderly Health Support and Learning Centre
City
Lai Chi Kok
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaman Chung
Phone
2310 4848
Email
lccwsa@pokoi.org.hk
Facility Name
Pok Oi Hospital Mr. Kwok Hing Kwan Neighbourhood Elderly Centre
City
Lai Chi Kok
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olive Sin
Phone
36146402
Email
khkic@pokoi.org.hk
Facility Name
Pok Oi Hospital Chan Ping Memorial Neighbourhood Elderly Centre
City
Tin Shui Wai
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandy Wong
Phone
24781930
Email
cpaic@pokoi.org.hk
Facility Name
Pok Oi Hospital Wong Muk Fung Memorial Elderly Health Support and Learning Centre
City
Tuen Mun
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shane WL Siauw
Phone
25650877
Email
wmfswa1@pokoi.org.hk
Facility Name
Pok Oi Hospital Mrs. Wong Tung Yuen District Elderly Community Centre
City
Yuen Long
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lai Yung Tong
Phone
2476 2227
Email
wtysswa1@pokoi.org.hk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25555677
Citation
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.
Results Reference
background
PubMed Identifier
15817019
Citation
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. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
Results Reference
background
PubMed Identifier
19672065
Citation
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.
Results Reference
background
PubMed Identifier
25125421
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.
Results Reference
background
PubMed Identifier
11253156
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. doi: 10.1093/gerona/56.3.m146.
Results Reference
background
PubMed Identifier
15954065
Citation
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.
Results Reference
background
PubMed Identifier
24154642
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, 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.
Results Reference
background
PubMed Identifier
27698558
Citation
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.
Results Reference
background
PubMed Identifier
27431673
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.
Results Reference
background
PubMed Identifier
29163146
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.
Results Reference
background
PubMed Identifier
29028622
Citation
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.
Results Reference
background
PubMed Identifier
28446889
Citation
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.
Results Reference
background
PubMed Identifier
22689311
Citation
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. Erratum In: Neurol Sci. 2015 Feb;36(2):345-7.
Results Reference
background
PubMed Identifier
29135021
Citation
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.
Results Reference
background
PubMed Identifier
22193353
Citation
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.
Results Reference
background
PubMed Identifier
5349366
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background

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VR Motor-cognitive Training for Older People With Cognitive Frailty

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