Clinical trial NCT04043416: Reminiscence Technology Balance and Mobility
Official title: Using Motivating Reminiscence Technology to Encourage Physical Activity and Improve Balance and Mobility for Residents in Long Term Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adults Living in Long Term Care
Keywords: Long Term Care
Motivating Reminiscence Technology
Feasibility
Lead sponsor: Bruyere Research Institute
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study has 2 six week campaigns with a six week washout in between the 2 campaigns. During the first campaign half of the participants will use the motivating reminiscence technology while receiving the standard fall prevention programming, while the second half will receive just the standard fall prevention programming. During the 6 week washout period all participants will just receive the standard fall prevention programming. After the washout period, there will be the second campaign where the other half of the participants will use the motivating reminiscence technology while receiving the standard fall prevention programming, whereas the remaining participants will just receive the standard fall prevention programming.
Primary purpose: TREATMENT

Brief summary: This study evaluates the feasibility of a larger randomized controlled trial to examine the effect of reminiscence aided physical activity on the balance and mobility of older adults living in long term care. The study uses the jDome BikeAround system, which is a stationary bicycle with a projector screen that runs google earth, as the user bicycles, the map progresses giving the appearance that the user is bicycling through the environment chosen. Half of the participants will use the system during the first 6 week campaign, there will then be a 6 week washout period. Following the washout period, there will be a second 6 week campaign when the other half of the participants will use the jDome BikeAround system.

Detailed description: Physical activity has been shown to have numerous benefits for physical well-being and function. Stationary cycling is one example of physical activity that can provide opportunities for residents who are inactive, living in long term care and are at high risk for falls.

The use of jDome BikeAround provides older adults in long term care an opportunity to engage in a motivating reminiscence activity that is coupled with physical activity. Participants will be divided into two groups, one group will take part in jDome BikeAround sessions 3x per week for 6 weeks in addition to The Glebe Centre's Fall Prevention program, while the second group will just participant in Fall Prevention program. There will be a 6 week wash out, then the second cohort will participant in the jDome Bike Around sessions 3x a week in addition to the Fall Prevention program while the first cohort will just participate in the Fall Prevention Program.

Participants will have their balance, mobility, leg strength, endurance tested as well as a tracking of fall risks at the beginning and end of each of the jDome BikeAround sessions (4 measurement points). Feasibility will be determined by the ability to enroll an adequate number of participants, protocol completion by participants, and the number of adverse events.

Eligibility criteria: Inclusion Criteria:

* Scott fall risk of 2-17 (this is the current range used by the Glebe Centre, there have been 0 falls during transportation to the equipment and during each session of the BikeAround system)
* Sufficient visual abilities to observe images on the domed screen
* Able to comprehend and communicate in English.
* Adequate attentional capacity to remain focused on the pedalling task.
* Minimum height requirement of 5'2" or 157cm in order to successfully fit the BikeAround system's stationary bike.

Exclusion Criteria:

* Physical limitations (as determined by the Glebe Centre healthcare/physiotherapy team) that prevent use of the jDome bike.
* Cognitive impairment (as determined by the Glebe Centre healthcare/physiotherapy team) Inability to sustain attention Inability to follow one-step commands.
* Known behavioural abnormalities (e.g. overly aggressive behavior) that in the opinion of the clinical care team might impede any meaningful participation in the project
* Those who are in the opinion of attending physician or clinical team too unwell to participate in the project
* Fully unable to complete outcome measures indicated (Section 7, Outcomes)

Primary outcomes:
measure: Number of Participants Recruited
timeFrame: Baseline
measure: Protocol Adherence
timeFrame: Week 18
measure: Number of Participants Who Experience an Adverse Events While Using the jDome BikeAround (System)
timeFrame: Week 18
measure: Performance Oriented Mobility Assessment
timeFrame: Baseline
measure: Performance Oriented Mobility Assessment
timeFrame: Week 6
measure: Performance Oriented Mobility Assessment
timeFrame: Week 12
measure: Performance Oriented Mobility Assessment
timeFrame: Week 18
Secondary outcomes:
measure: 2 Minute Walk Test
timeFrame: Baseline
measure: 2 Minute Walk Test
timeFrame: 6 Week
measure: 2 Minute Walk Test
timeFrame: 12 Week
measure: 2 Minute Walk Test
timeFrame: 18 Week
measure: Knee Range of Motion Test
timeFrame: Baseline
measure: Knee Range of Motion Test
timeFrame: 6 weeks
measure: Knee Range of Motion Test
timeFrame: 12 weeks
measure: Knee Range of Motion Test
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Glebe Centre
state: Ontario
Study officials:
affiliation: Bruyere Continuing Care
name: Mark Campbell, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Vogel T, Brechat PH, Lepretre PM, Kaltenbach G, Berthel M, Lonsdorfer J. Health benefits of physical activity in older patients: a review. Int J Clin Pract. 2009 Feb;63(2):303-20. doi: 10.1111/j.1742-1241.2008.01957.x.
citation: Menne HL, Johnson JD, Whitlatch CJ, Schwartz SM. Activity Preferences of Persons With Dementia. Activities, Adaptation & Aging, 36(3): 195-213, 2012. DOI: 10.1080/01924788.2012.696234
citation: Benjamin K, Edwards N, Ploeg J, Legault F. Barriers to physical activity and restorative care for residents in long-term care: a review of the literature. J Aging Phys Act. 2014 Jan;22(1):154-65. doi: 10.1123/japa.2012-0139. Epub 2013 Feb 20.
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citation: Varela S, Cancela JM, Seijo-Martinez M, Ayan C. Self-Paced Cycling Improves Cognition on Institutionalized Older Adults Without Known Cognitive Impairment: A 15-Month Randomized Controlled Trial. J Aging Phys Act. 2018 Oct 1;26(4):614-623. doi: 10.1123/japa.2017-0135. Epub 2018 Sep 8.
citation: Batcir S, Melzer I. Daily Bicycling in Older Adults May be Effective to Reduce Fall Risks-A Case-Control Study. J Aging Phys Act. 2018 Oct 1;26(4):570-576. doi: 10.1123/japa.2017-0263. Epub 2018 Aug 29.
citation: Harvey S, Rissel C, Pijnappels M. Associations Between Bicycling and Reduced Fall-Related Physical Performance in Older Adults. J Aging Phys Act. 2018 Jul 1;26(3):514-519. doi: 10.1123/japa.2017-0243. Epub 2018 Jun 22.
citation: Macaluso A, Young A, Gibb KS, Rowe DA, De Vito G. Cycling as a novel approach to resistance training increases muscle strength, power, and selected functional abilities in healthy older women. J Appl Physiol (1985). 2003 Dec;95(6):2544-53. doi: 10.1152/japplphysiol.00416.2003. Epub 2003 Aug 22.
citation: Huang HC, Chen YT, Chen PY, Huey-Lan Hu S, Liu F, Kuo YL, Chiu HY. Reminiscence Therapy Improves Cognitive Functions and Reduces Depressive Symptoms in Elderly People With Dementia: A Meta-Analysis of Randomized Controlled Trials. J Am Med Dir Assoc. 2015 Dec;16(12):1087-94. doi: 10.1016/j.jamda.2015.07.010. Epub 2015 Sep 1.
citation: Karssemeijer EGA, Aaronson JA, Bossers WJ, Smits T, Olde Rikkert MGM, Kessels RPC. Positive effects of combined cognitive and physical exercise training on cognitive function in older adults with mild cognitive impairment or dementia: A meta-analysis. Ageing Res Rev. 2017 Nov;40:75-83. doi: 10.1016/j.arr.2017.09.003. Epub 2017 Sep 12.