Clinical trial NCT05130203: Developing and Assessing an Innovative Exergaming Technology for Older Adults Living in Long-term Care Homes
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
Overall status: RECRUITING
Phase: NA
Conditions: Physical Inactivity
Cognitive Decline
Aging
Social Isolation
Keywords: nursing homes
long-term care
exergaming
user-centered design
older adult
aging
depression
dementia
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Social Sciences and Humanities Research Council of Canada
First posted: 2021-11-23
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Residents living in long-term care (LTC) homes spend up to 75% of their day in sedentary, socially withdrawn situations which increases their risk for depression, dementia, decreased functional status and increased care costs.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

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.

Eligibility criteria: Inclusion Criteria:

* 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.

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

Primary outcomes:
measure: Change in mean mobility scores on the Timed-up-and-Go test
timeFrame: Baseline and mid-point of the intervention (3 weeks)
measure: Change in mean mobility scores on the Timed-up-and-Go test
timeFrame: Baseline and following the completion of the intervention (6 weeks)
measure: Change in mean mobility scores on the 2-Minute Walk Test
timeFrame: Baseline and mid-point of the intervention (3 weeks)
measure: Change in mean mobility scores on the 2-Minute Walk Test
timeFrame: Baseline and following the completion of the intervention (6 weeks)
measure: Adverse events (e.g. injury) related to exergame use
timeFrame: Over the course of the intervention (baseline to 6 weeks)
measure: Feasibility related to adherence rate
timeFrame: Over the course of the intervention (baseline to 6 weeks)
Secondary outcomes:
measure: Change in mean working memory scores on digit span
timeFrame: Baseline and mid-point of the intervention (3 weeks)
measure: Change in mean working memory scores on digit span
timeFrame: Baseline and following the completion of the intervention (6 weeks)
measure: Change in mean basic attention/psychomotor speed on the Trail Making Test A
timeFrame: Baseline and mid-point of the intervention (3 weeks)
measure: Change in mean basic attention/psychomotor speed on the Trail Making Test A
timeFrame: Baseline and following the completion of the intervention (6 weeks)
measure: Change in mean alternating attention scores on the Trail Making Test B
timeFrame: Baseline and mid-point of the intervention (3 weeks)
measure: Change in mean alternating attention scores on the Trail Making Test B
timeFrame: Baseline and following the completion of the intervention (6 weeks)
measure: Change in errors made on an alternating sequences test
timeFrame: Baseline and mid-point of the intervention (3 weeks)
measure: Change in errors made on an alternating sequences test
timeFrame: Baseline and following the completion of the intervention (6 weeks)
measure: Change in mean verbal fluency scores
timeFrame: Baseline and mid-point of the intervention (3 weeks)
measure: Change in mean verbal fluency scores
timeFrame: Baseline and following the completion of the intervention (6 weeks)
measure: Change in mean scores for social isolation assessed by UCLA Loneliness Scale 3
timeFrame: Baseline and mid-point of the intervention (3 weeks)
measure: Change in mean scores for social isolation assessed by UCLA Loneliness Scale 3
timeFrame: Baseline and following the completion of the intervention (6 weeks)
measure: Change in mean scores on the Cornell Scale for Depression in Dementia
timeFrame: Baseline and mid-point of the intervention (3 weeks)
measure: Change in mean scores on the Cornell Scale for Depression in Dementia
timeFrame: Baseline and following the completion of the intervention (6 weeks)
Other outcomes:
measure: Acceptability on a version of the modified Treatment Evaluation Inventory (m-TEI) adapted for exergame use
timeFrame: Following the completion of the intervention (6 weeks)
measure: Semi-structured interviews to evaluate the acceptability of the technology, design, usability and enjoyment, potential facilitators and barriers
timeFrame: Following the completion of the intervention (6 weeks)
Locations:
city: Toronto
country: Canada
facility: Chester Village
city: Toronto
country: Canada
facility: Kensington Gardens
Study officials:
affiliation: University of Toronto
name: Charlene Chu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.