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Developing and Assessing an Innovative Exergaming Technology for Older Adults Living in Long-term Care Homes (MouvMat)

Primary Purpose

Physical Inactivity, Cognitive Decline, Aging

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MouvMat Exergaming
Standard Recreational Programming
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Physical Inactivity focused on measuring nursing homes, long-term care, exergaming, user-centered design, older adult, aging, depression, dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All residents at the participating long-term care homes are eligible if they are 65 years of age or older
  • Ability to communicate and speak English
  • Able to provide informed consent or have a substitute decision maker (SDM) who provides informed consent
  • A family member, friend, or personally-hired caregiver of an older adult residing in one of our participating LTC facilities are eligible to participate if they are 18 years of age or older, can communicate and speak English
  • The LTC resident does not need to be enrolled in or study in order for their family member/friend/caregiver to participate
  • LTC staff are eligible if they can communicate and speak English, are currently working in one of the participating LTC facilities, have at least 6 months experience working with older adults in LTC, providing or supervising physical or recreational activities, or involved with purchasing or directing these activities, and are a member of one of the following professions/positions: physiotherapist, physiotherapy assistant, recreational therapist, or LTC administrator.

Exclusion Criteria:

  • Residents will be ineligible to participate in the study is they cannot communicate or speak English
  • Residents who typically do not participate in recreational activities
  • Residents who have a severe sensory (e.g., deaf, blind) or severe to moderate cognitive impairment AND/OR scores less than 20 on the Mini- Mental Status Examination (MMSE)
  • Family Members who cannot communicate or speak English
  • Family Members who cannot interact with the MouvMat due to sensory limitations (i.e., severe visual or auditory impairment)
  • Family Members who cannot provide verbal feedback

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    MouvMat Exergaming

    Standard Recreational Programming

    Arm Description

    Older adults in the intervention group will participate in a 6-week, 3 times per week, 45 minutes per session exercise program involving use of the MouvMat. Each resident from the intervention group will engage with the exergame supervised by a qualified and trained RA. Each intervention session will involve groups of 4-5 participants, with participants taking turns. An RA blinded to participants' condition will collect the outcome data.

    A control group will meet on a similar schedule as the MouvMat group for standard recreational programming conducted by onsite recreational therapists. The same RA from the experimental group will collect outcome measurements from control group participants.

    Outcomes

    Primary Outcome Measures

    Change in mean mobility scores on the Timed-up-and-Go test
    Completion time in seconds when participant sits in a standard armchair and is instructed to stand up and walk to a line 3 m away at their normal pace, turn around and sit back down in the chair.
    Change in mean mobility scores on the Timed-up-and-Go test
    Completion time in seconds when participant sits in a standard armchair and is instructed to stand up and walk to a line 3 m away at their normal pace, turn around and sit back down in the chair.
    Change in mean mobility scores on the 2-Minute Walk Test
    Distance walked in meters when a participant is instructed to walk at the fastest speed that they can for 2 minutes.
    Change in mean mobility scores on the 2-Minute Walk Test
    Distance walked in meters when a participant is instructed to walk at the fastest speed that they can for 2 minutes.
    Adverse events (e.g. injury) related to exergame use
    Number of adverse events related to use of the exergame in the intervention group
    Feasibility related to adherence rate
    Mean percentage of sessions attended in the intervention group (i.e., number of sessions attended / total scheduled sessions)

    Secondary Outcome Measures

    Change in mean working memory scores on digit span
    Total scores for the WAIS-III forward and backward digit span, in which participants are asked to repeat a series of digits that are read by an experimenter in the same order (forward) or reverse order (backward).
    Change in mean working memory scores on digit span
    Total scores for the WAIS-III forward and backward digit span, in which participants are asked to repeat a series of digits that are read by an experimenter in the same order (forward) or reverse order (backward).
    Change in mean basic attention/psychomotor speed on the Trail Making Test A
    Time to completion in seconds on a task requiring connecting numbered dots on a page in order as quickly as possible.
    Change in mean basic attention/psychomotor speed on the Trail Making Test A
    Time to completion in seconds on a task requiring connecting numbered dots on a page in order as quickly as possible.
    Change in mean alternating attention scores on the Trail Making Test B
    Time to completion in seconds on a task requiring switching between connecting numbers and letters in dots on a page as quickly as possible.
    Change in mean alternating attention scores on the Trail Making Test B
    Time to completion in seconds on a task requiring switching between connecting numbers and letters in dots on a page as quickly as possible.
    Change in errors made on an alternating sequences test
    Number of errors made on a task requiring alternating between drawing two designs. This test is sensitive to cognitive problems with executive functions including inhibition and perseveration.
    Change in errors made on an alternating sequences test
    Number of errors made on a task requiring alternating between drawing two designs. This test is sensitive to cognitive problems with executive functions including inhibition and perseveration.
    Change in mean verbal fluency scores
    Number of words generated in one minute given a letter cue
    Change in mean verbal fluency scores
    Number of words generated in one minute given a letter cue
    Change in mean scores for social isolation assessed by UCLA Loneliness Scale 3
    Total score on a 20-item questionnaire that assesses how often a person feels lonely and isolated from others.
    Change in mean scores for social isolation assessed by UCLA Loneliness Scale 3
    Total score on a 20-item questionnaire that assesses how often a person feels lonely and isolated from others.
    Change in mean scores on the Cornell Scale for Depression in Dementia
    Total scores on a measure based on interviews on 19 items related to depression.
    Change in mean scores on the Cornell Scale for Depression in Dementia
    Total scores on a measure based on interviews on 19 items related to depression.

    Full Information

    First Posted
    November 10, 2021
    Last Updated
    November 10, 2021
    Sponsor
    University of Toronto
    Collaborators
    Social Sciences and Humanities Research Council of Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05130203
    Brief Title
    Developing and Assessing an Innovative Exergaming Technology for Older Adults Living in Long-term Care Homes
    Acronym
    MouvMat
    Official Title
    Developing and Assessing an Innovative Exergaming Technology for Older Adults Living in Long-term Care Homes With a User-centered Design Approach
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2022 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Toronto
    Collaborators
    Social Sciences and Humanities Research Council of Canada

    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
    Residents living in long-term care (LTC) homes spend up to 75% of their day in sedentary, socially withdrawn situations which increases their risk for depression, dementia, decreased functional status and increased care costs. Physical activity is an accepted intervention to improve the physical health, cognition, and well-being of older adults. Moreover, systematic reviews have found that exergaming (i.e. physical activity gamified with technology) offers physical, cognitive, and social benefits by means of dual-task activities that engage both motor and cognitive abilities. The effect of exergaming for older adults in LTC is less clear, as this population has greater health needs related to physical health conditions, cognitive impairment, and functional dependence. Given the increased global demand for LTC, there is a need to develop and assess innovative exergaming technologies that can support the physical and cognitive health of LTC residents. MouvMat is an exergaming technology intervention with an interactive digital gaming surface designed for older adults (OA) in LTC settings. They can play familiar games, like Simon or Bingo, by stepping on or tapping the surface with an assistive pointing device. Games can be played individually or with multiple players. LED lights on the surface provide an adaptive digital display and embedded pressure sensors respond to players' input. The investigators collaboratively designed a preliminary prototype with OA aged 65 and older in a pilot project. The overall objective of this proposal is to conduct a pilot RCT of the Mouvmat to evaluate the feasibility, acceptability and efficacy of the exergaming technology to improve the primary outcome of mobility, and the secondary outcomes of cognitive function and social isolation compared to a usual care control group receiving standard recreational programming by recreational therapists.
    Detailed Description
    Our sample size calculation was completed based on an effect size of 0.65 (power = 0.80; 2-tailed; α= 0.05). Assuming a 10% attrition rate, we will recruit a total of 60 residents (30 people in a control group and 30 people in the intervention group). A block randomization design with sequentially numbered, opaque, sealed envelopes to conceal the randomization sequence will be used to assign participants to groups. We will attempt to recruit equal numbers of men and women with a range of mobility requirements (i.e., ambulate independently, using gait aids such as canes or walkers). In addition, a mix of approximately 6-10 LTC staff and resident family members will be recruited at the end of the trial to conduct semi-structured interviews to understand the acceptability of the technology, design, usability and enjoyment, potential facilitators and barriers to exergame technology.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Physical Inactivity, Cognitive Decline, Aging, Social Isolation
    Keywords
    nursing homes, long-term care, exergaming, user-centered design, older adult, aging, depression, dementia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MouvMat Exergaming
    Arm Type
    Experimental
    Arm Description
    Older adults in the intervention group will participate in a 6-week, 3 times per week, 45 minutes per session exercise program involving use of the MouvMat. Each resident from the intervention group will engage with the exergame supervised by a qualified and trained RA. Each intervention session will involve groups of 4-5 participants, with participants taking turns. An RA blinded to participants' condition will collect the outcome data.
    Arm Title
    Standard Recreational Programming
    Arm Type
    Other
    Arm Description
    A control group will meet on a similar schedule as the MouvMat group for standard recreational programming conducted by onsite recreational therapists. The same RA from the experimental group will collect outcome measurements from control group participants.
    Intervention Type
    Behavioral
    Intervention Name(s)
    MouvMat Exergaming
    Intervention Description
    Sessions engaging with exergaming device.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard Recreational Programming
    Intervention Description
    Conducted by recreational therapists.
    Primary Outcome Measure Information:
    Title
    Change in mean mobility scores on the Timed-up-and-Go test
    Description
    Completion time in seconds when participant sits in a standard armchair and is instructed to stand up and walk to a line 3 m away at their normal pace, turn around and sit back down in the chair.
    Time Frame
    Baseline and mid-point of the intervention (3 weeks)
    Title
    Change in mean mobility scores on the Timed-up-and-Go test
    Description
    Completion time in seconds when participant sits in a standard armchair and is instructed to stand up and walk to a line 3 m away at their normal pace, turn around and sit back down in the chair.
    Time Frame
    Baseline and following the completion of the intervention (6 weeks)
    Title
    Change in mean mobility scores on the 2-Minute Walk Test
    Description
    Distance walked in meters when a participant is instructed to walk at the fastest speed that they can for 2 minutes.
    Time Frame
    Baseline and mid-point of the intervention (3 weeks)
    Title
    Change in mean mobility scores on the 2-Minute Walk Test
    Description
    Distance walked in meters when a participant is instructed to walk at the fastest speed that they can for 2 minutes.
    Time Frame
    Baseline and following the completion of the intervention (6 weeks)
    Title
    Adverse events (e.g. injury) related to exergame use
    Description
    Number of adverse events related to use of the exergame in the intervention group
    Time Frame
    Over the course of the intervention (baseline to 6 weeks)
    Title
    Feasibility related to adherence rate
    Description
    Mean percentage of sessions attended in the intervention group (i.e., number of sessions attended / total scheduled sessions)
    Time Frame
    Over the course of the intervention (baseline to 6 weeks)
    Secondary Outcome Measure Information:
    Title
    Change in mean working memory scores on digit span
    Description
    Total scores for the WAIS-III forward and backward digit span, in which participants are asked to repeat a series of digits that are read by an experimenter in the same order (forward) or reverse order (backward).
    Time Frame
    Baseline and mid-point of the intervention (3 weeks)
    Title
    Change in mean working memory scores on digit span
    Description
    Total scores for the WAIS-III forward and backward digit span, in which participants are asked to repeat a series of digits that are read by an experimenter in the same order (forward) or reverse order (backward).
    Time Frame
    Baseline and following the completion of the intervention (6 weeks)
    Title
    Change in mean basic attention/psychomotor speed on the Trail Making Test A
    Description
    Time to completion in seconds on a task requiring connecting numbered dots on a page in order as quickly as possible.
    Time Frame
    Baseline and mid-point of the intervention (3 weeks)
    Title
    Change in mean basic attention/psychomotor speed on the Trail Making Test A
    Description
    Time to completion in seconds on a task requiring connecting numbered dots on a page in order as quickly as possible.
    Time Frame
    Baseline and following the completion of the intervention (6 weeks)
    Title
    Change in mean alternating attention scores on the Trail Making Test B
    Description
    Time to completion in seconds on a task requiring switching between connecting numbers and letters in dots on a page as quickly as possible.
    Time Frame
    Baseline and mid-point of the intervention (3 weeks)
    Title
    Change in mean alternating attention scores on the Trail Making Test B
    Description
    Time to completion in seconds on a task requiring switching between connecting numbers and letters in dots on a page as quickly as possible.
    Time Frame
    Baseline and following the completion of the intervention (6 weeks)
    Title
    Change in errors made on an alternating sequences test
    Description
    Number of errors made on a task requiring alternating between drawing two designs. This test is sensitive to cognitive problems with executive functions including inhibition and perseveration.
    Time Frame
    Baseline and mid-point of the intervention (3 weeks)
    Title
    Change in errors made on an alternating sequences test
    Description
    Number of errors made on a task requiring alternating between drawing two designs. This test is sensitive to cognitive problems with executive functions including inhibition and perseveration.
    Time Frame
    Baseline and following the completion of the intervention (6 weeks)
    Title
    Change in mean verbal fluency scores
    Description
    Number of words generated in one minute given a letter cue
    Time Frame
    Baseline and mid-point of the intervention (3 weeks)
    Title
    Change in mean verbal fluency scores
    Description
    Number of words generated in one minute given a letter cue
    Time Frame
    Baseline and following the completion of the intervention (6 weeks)
    Title
    Change in mean scores for social isolation assessed by UCLA Loneliness Scale 3
    Description
    Total score on a 20-item questionnaire that assesses how often a person feels lonely and isolated from others.
    Time Frame
    Baseline and mid-point of the intervention (3 weeks)
    Title
    Change in mean scores for social isolation assessed by UCLA Loneliness Scale 3
    Description
    Total score on a 20-item questionnaire that assesses how often a person feels lonely and isolated from others.
    Time Frame
    Baseline and following the completion of the intervention (6 weeks)
    Title
    Change in mean scores on the Cornell Scale for Depression in Dementia
    Description
    Total scores on a measure based on interviews on 19 items related to depression.
    Time Frame
    Baseline and mid-point of the intervention (3 weeks)
    Title
    Change in mean scores on the Cornell Scale for Depression in Dementia
    Description
    Total scores on a measure based on interviews on 19 items related to depression.
    Time Frame
    Baseline and following the completion of the intervention (6 weeks)
    Other Pre-specified Outcome Measures:
    Title
    Acceptability on a version of the modified Treatment Evaluation Inventory (m-TEI) adapted for exergame use
    Description
    Mean total score from intervention group participants and family members/staff
    Time Frame
    Following the completion of the intervention (6 weeks)
    Title
    Semi-structured interviews to evaluate the acceptability of the technology, design, usability and enjoyment, potential facilitators and barriers
    Description
    A semi-structured interview will be completed with residents in the intervention group, as well as stakeholders including family members and staff, with questions designed to understand the acceptability of the technology, design, usability and enjoyment, potential facilitators and barriers to exergame technology. The post-intervention interviews will be analyzed using thematic analysis.
    Time Frame
    Following the completion of the intervention (6 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All residents at the participating long-term care homes are eligible if they are 65 years of age or older Ability to communicate and speak English Able to provide informed consent or have a substitute decision maker (SDM) who provides informed consent A family member, friend, or personally-hired caregiver of an older adult residing in one of our participating LTC facilities are eligible to participate if they are 18 years of age or older, can communicate and speak English The LTC resident does not need to be enrolled in or study in order for their family member/friend/caregiver to participate LTC staff are eligible if they can communicate and speak English, are currently working in one of the participating LTC facilities, have at least 6 months experience working with older adults in LTC, providing or supervising physical or recreational activities, or involved with purchasing or directing these activities, and are a member of one of the following professions/positions: physiotherapist, physiotherapy assistant, recreational therapist, or LTC administrator. Exclusion Criteria: Residents will be ineligible to participate in the study is they cannot communicate or speak English Residents who typically do not participate in recreational activities Residents who have a severe sensory (e.g., deaf, blind) or severe to moderate cognitive impairment AND/OR scores less than 20 on the Mini- Mental Status Examination (MMSE) Family Members who cannot communicate or speak English Family Members who cannot interact with the MouvMat due to sensory limitations (i.e., severe visual or auditory impairment) Family Members who cannot provide verbal feedback
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Charlene Chu, PhD
    Phone
    416-946-0217
    Email
    charlene.chu@utoronto.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shefali Ram
    Phone
    416-946-8304
    Email
    s.ram@utoronto.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charlene Chu, PhD
    Organizational Affiliation
    University of Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23664785
    Citation
    Ikezoe T, Asakawa Y, Shima H, Kishibuchi K, Ichihashi N. Daytime physical activity patterns and physical fitness in institutionalized elderly women: an exploratory study. Arch Gerontol Geriatr. 2013 Sep-Oct;57(2):221-5. doi: 10.1016/j.archger.2013.04.004. Epub 2013 May 9.
    Results Reference
    background
    PubMed Identifier
    30325875
    Citation
    Chu CH, Puts M, Brooks D, Parry M, McGilton KS. A Feasibility Study of a Multifaceted Walking Intervention to Maintain the Functional Mobility, Activities of Daily Living, and Quality of Life of Nursing Home Residents With Dementia. Rehabil Nurs. 2020 Jul/Aug;45(4):204-217. doi: 10.1097/rnj.0000000000000186.
    Results Reference
    background
    PubMed Identifier
    27786518
    Citation
    Shankar A, McMunn A, Demakakos P, Hamer M, Steptoe A. Social isolation and loneliness: Prospective associations with functional status in older adults. Health Psychol. 2017 Feb;36(2):179-187. doi: 10.1037/hea0000437. Epub 2016 Oct 27.
    Results Reference
    background
    PubMed Identifier
    27012368
    Citation
    de Souto Barreto P, Morley JE, Chodzko-Zajko W, H Pitkala K, Weening-Djiksterhuis E, Rodriguez-Manas L, Barbagallo M, Rosendahl E, Sinclair A, Landi F, Izquierdo M, Vellas B, Rolland Y; International Association of Gerontology and Geriatrics - Global Aging Research Network (IAGG-GARN) and the IAGG European Region Clinical Section. Recommendations on Physical Activity and Exercise for Older Adults Living in Long-Term Care Facilities: A Taskforce Report. J Am Med Dir Assoc. 2016 May 1;17(5):381-92. doi: 10.1016/j.jamda.2016.01.021. Epub 2016 Mar 21.
    Results Reference
    background
    PubMed Identifier
    26520231
    Citation
    Beard JR, Officer A, de Carvalho IA, Sadana R, Pot AM, Michel JP, Lloyd-Sherlock P, Epping-Jordan JE, Peeters GMEEG, Mahanani WR, Thiyagarajan JA, Chatterji S. The World report on ageing and health: a policy framework for healthy ageing. Lancet. 2016 May 21;387(10033):2145-2154. doi: 10.1016/S0140-6736(15)00516-4. Epub 2015 Oct 29.
    Results Reference
    background
    PubMed Identifier
    33687337
    Citation
    Chu CH, Biss RK, Cooper L, Quan AML, Matulis H. Exergaming Platform for Older Adults Residing in Long-Term Care Homes: User-Centered Design, Development, and Usability Study. JMIR Serious Games. 2021 Mar 9;9(1):e22370. doi: 10.2196/22370.
    Results Reference
    background

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