AzTrials
AzTrials

Physical InactivityMouvMatNCT05130203

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

A study testing MouvMat Exergaming and Standard Recreational Programming in people with Physical Inactivity and Cognitive Decline, run by University of Toronto at 2 sites in Canada.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial 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Residents living in long-term care (LTC) homes spend up to 75% of their day in sedentary, socially withdrawn situations which increases their risk for depression, dementia, decreased functional status and increased care costs. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Physical Inactivity, Cognitive Decline, Aging
What is being tested?
MouvMat Exergaming and Standard Recreational Programming
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesCanada
Study dates
1 Oct 2022to Jan 2025
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 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All residents at the participating long-term care homes are eligible if they are 55 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Charlene Chu, PhD contact

416-946-0217

charlene.chu@utoronto.ca

Canada2 sites, 1 recruiting
  • Chester Village

    Toronto

    Completed
  • Kensington Gardens

    Toronto

    Charlene

    Recruiting

Other trials in Canada

About this study

Official title: Developing and Assessing an Innovative Exergaming Technology for Older Adults Living in Long-term Care Homes With a User-centered Design Approach

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. Participants 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.

Read the detailed description

The sample size calculation was completed based on an effect size of 0.65 (power = 0.80; 2-tailed; α= 0.05). Assuming a 5% attrition rate, a total of 56 residents (28 people in a control group and 28 people in the intervention group) will be recruited. A block randomization design using a number generator to conceal the randomization sequence will be used to assign participants' units to the intervention or control groups. Block randomization was conducted to comply with COVID-19 restrictions. The investigators 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 5-10 LTC staff and/or residents' 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.

Being tested
MouvMat Exergaming, Standard Recreational Programming
Keywords
nursing homes, long-term care, exergaming, user-centered design, older adult, aging, depression, dementia
Medical subject headings
Sedentary Behavior, Cognitive Dysfunction, Social Isolation, Depression, Dementia

What participants receive

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

  • MouvMat ExergamingBehavioural

    Sessions engaging with exergaming device.

  • Standard Recreational ProgrammingBehavioural

    Conducted by recreational therapists.

Study groups in NCT05130203
Study groupRoleWhat they receive
MouvMat ExergamingExperimentalOlder 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.
Receives: Behavioral: MouvMat Exergaming
Standard Recreational ProgrammingOtherA 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.
Receives: Behavioral: Standard Recreational Programming

What is being measured

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

  1. 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.

    Measured: Baseline and mid-point of the intervention (3 weeks)

  2. 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.

    Measured: Baseline and following the completion of the intervention (6 weeks)

  3. 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.

    Measured: Baseline and mid-point of the intervention (3 weeks)

  4. 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.

    Measured: Baseline and following the completion of the intervention (6 weeks)

  5. Adverse events (e.g. injury) related to exergame use

    Number of adverse events related to use of the exergame in the intervention group

    Measured: Over the course of the intervention (baseline to 6 weeks)

  6. Feasibility related to adherence rate

    Mean percentage of sessions attended in the intervention group (i.e., number of sessions attended / total scheduled sessions)

    Measured: Over the course of the intervention (baseline to 6 weeks)

Secondary outcomes (14)
  1. 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).

    Measured: Baseline and mid-point of the intervention (3 weeks)

  2. 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).

    Measured: Baseline and following the completion of the intervention (6 weeks)

  3. 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.

    Measured: Baseline and mid-point of the intervention (3 weeks)

  4. 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.

    Measured: Baseline and following the completion of the intervention (6 weeks)

  5. 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.

    Measured: Baseline and mid-point of the intervention (3 weeks)

  6. 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.

    Measured: Baseline and following the completion of the intervention (6 weeks)

  7. 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.

    Measured: Baseline and mid-point of the intervention (3 weeks)

  8. 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.

    Measured: Baseline and following the completion of the intervention (6 weeks)

  9. Change in mean verbal fluency scores

    Number of words generated in one minute given a letter cue

    Measured: Baseline and mid-point of the intervention (3 weeks)

  10. Change in mean verbal fluency scores

    Number of words generated in one minute given a letter cue

    Measured: Baseline and following the completion of the intervention (6 weeks)

  11. 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.

    Measured: Baseline and mid-point of the intervention (3 weeks)

  12. 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.

    Measured: Baseline and following the completion of the intervention (6 weeks)

  13. 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.

    Measured: Baseline and mid-point of the intervention (3 weeks)

  14. 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.

    Measured: Baseline and following the completion of the intervention (6 weeks)

Timeline

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

  1. First posted23 Nov 2021
  2. Study start1 Oct 2022
  3. Primary completionJan 2025 (estimated)
  4. Study completionJan 2025 (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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05130203
Sponsor's protocol ID
00693
Acronym
MouvMat
Status last verified
Jun 2024
First submitted
10 Nov 2021
Last updated
13 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 23664785
  • 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.

    PubMed 30325875
  • 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.

    PubMed 27786518
  • 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.

    PubMed 27012368
  • 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.

    PubMed 26520231
  • 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.

    PubMed 33687337

Questions about this trial

What is this clinical trial studying?

A study testing MouvMat Exergaming and Standard Recreational Programming in people with Physical Inactivity and Cognitive Decline, run by University of Toronto at 2 sites in Canada.

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 6 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 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. 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 Charlene Chu, PhD (416-946-0217, charlene.chu@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in mean mobility scores on the Timed-up-and-Go test (time frame: Baseline and mid-point of the intervention (3 weeks)). The study lists 6 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 NCT05130203, which also lists 6 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 13 Jun 2024.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in