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

NCT05130203 | Recruiting

• 1 other identifier: 00693
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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Residents living in long-term care (LTC) homes spend up to 75% of their day in sedentary, socially withdrawn situations which increases their risk for depression, dementia, decreased functional status and increased care costs.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

Conditions

Physical Inactivity; Cognitive Decline; Aging; Social Isolation

Keywords

nursing homes; long-term care; exergaming; user-centered design; older adult; aging; depression; dementia

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (14)

• Change in mean working memory scores on digit span

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

• Change in mean working memory scores on digit span

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

• Change in mean basic attention/psychomotor speed on the Trail Making Test A

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

• Change in mean basic attention/psychomotor speed on the Trail Making Test A

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

• Change in mean alternating attention scores on the Trail Making Test B

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

Other Outcomes (2)

• Acceptability on a version of the modified Treatment Evaluation Inventory (m-TEI) adapted for exergame use

  Following the completion of the intervention (6 weeks)

• Semi-structured interviews to evaluate the acceptability of the technology, design, usability and enjoyment, potential facilitators and barriers

  Following the completion of the intervention (6 weeks)

Study Arms (2)

MouvMat Exergaming

EXPERIMENTAL

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.

Behavioral: MouvMat Exergaming

Standard Recreational Programming

OTHER

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.

Behavioral: Standard Recreational Programming

Interventions

MouvMat Exergaming BEHAVIORAL

Sessions engaging with exergaming device.

MouvMat Exergaming

Standard Recreational Programming BEHAVIORAL

Conducted by recreational therapists.

Standard Recreational Programming

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• Social Sciences and Humanities Research Council of Canada: collaborator

Study Sites (2)

Chester Village

Toronto, Canada

COMPLETED

Kensington Gardens

Toronto, Canada

RECRUITING

Related Publications (6)

• 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.

  PMID: 23664785 BACKGROUND

• 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.

  PMID: 30325875 BACKGROUND

• 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.

  PMID: 27786518 BACKGROUND

• 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.

  PMID: 27012368 BACKGROUND

• 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.

  PMID: 26520231 BACKGROUND

• 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.

  PMID: 33687337 BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior; Cognitive Dysfunction; Social Isolation; Depression; Dementia

Condition Hierarchy (Ancestors)

Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Social Behavior; Behavioral Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Charlene Chu, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlene Chu, PhD

CONTACT

416-946-0217; charlene.chu@utoronto.ca

Shefali Ram

CONTACT

416-946-8304; s.ram@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 23, 2021
• Study Start: October 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

CA (2)