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

Aging Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05130203
• Other study ID #: 00693
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: University of Toronto
• Contact: Charlene Chu, PhD
• Phone: 416-946-0217
• Email: charlene.chu[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

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Residents living in long-term care (LTC) homes spend up to 75% of their day in sedentary, socially withdrawn situations which increases their risk for depression, dementia, decreased functional status and increased care costs.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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cognitive Decline
• Cognitive Dysfunction
• Physical Inactivity
• Social Isolation

Intervention

Behavioral:
• MouvMat Exergaming
Sessions engaging with exergaming device.
• Standard Recreational Programming
Conducted by recreational therapists.

Locations

Country	Name	City	State
Canada	Chester Village	Toronto
Canada	Kensington Gardens	Toronto

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Social Sciences and Humanities Research Council of Canada

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability on a version of the modified Treatment Evaluation Inventory (m-TEI) adapted for exergame use	Mean total score from intervention group participants and family members/staff	Following the completion of the intervention (6 weeks)
Other	Semi-structured interviews to evaluate the acceptability of the technology, design, usability and enjoyment, potential facilitators and barriers	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.	Following the completion of the intervention (6 weeks)
Primary	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.	Baseline and mid-point of the intervention (3 weeks)
Primary	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.	Baseline and following the completion of the intervention (6 weeks)
Primary	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.	Baseline and mid-point of the intervention (3 weeks)
Primary	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.	Baseline and following the completion of the intervention (6 weeks)
Primary	Adverse events (e.g. injury) related to exergame use	Number of adverse events related to use of the exergame in the intervention group	Over the course of the intervention (baseline to 6 weeks)
Primary	Feasibility related to adherence rate	Mean percentage of sessions attended in the intervention group (i.e., number of sessions attended / total scheduled sessions)	Over the course of the intervention (baseline to 6 weeks)
Secondary	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).	Baseline and mid-point of the intervention (3 weeks)
Secondary	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).	Baseline and following the completion of the intervention (6 weeks)
Secondary	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.	Baseline and mid-point of the intervention (3 weeks)
Secondary	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.	Baseline and following the completion of the intervention (6 weeks)
Secondary	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.	Baseline and mid-point of the intervention (3 weeks)
Secondary	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.	Baseline and following the completion of the intervention (6 weeks)
Secondary	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.	Baseline and mid-point of the intervention (3 weeks)
Secondary	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.	Baseline and following the completion of the intervention (6 weeks)
Secondary	Change in mean verbal fluency scores	Number of words generated in one minute given a letter cue	Baseline and mid-point of the intervention (3 weeks)
Secondary	Change in mean verbal fluency scores	Number of words generated in one minute given a letter cue	Baseline and following the completion of the intervention (6 weeks)
Secondary	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.	Baseline and mid-point of the intervention (3 weeks)
Secondary	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.	Baseline and following the completion of the intervention (6 weeks)
Secondary	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.	Baseline and mid-point of the intervention (3 weeks)
Secondary	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.	Baseline and following the completion of the intervention (6 weeks)