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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04043416
Other study ID # M16-19-012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 13, 2019
Est. completion date December 31, 2019

Study information

Verified date July 2020
Source Bruyere Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date December 31, 2019
Est. primary completion date November 18, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Motivating reminiscence technology
The jDome BikeAround uses Google Street View, a stationary bike and a domed screen. Residents are seated in front of the screen; their destination is typed into the computer and when loaded the image appears on the screen. Using pedals on the bike they can propel themselves down the street, steer and change direction as they wish.

Locations

Country Name City State
Canada The Glebe Centre Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
Bruyere Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (11)

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. — View 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. Review. — View Citation

de Hollander EL, Proper KI. Physical activity levels of adults with various physical disabilities. Prev Med Rep. 2018 Apr 24;10:370-376. doi: 10.1016/j.pmedr.2018.04.017. eCollection 2018 Jun. — View 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. — View 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. — View 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. Review. — View Citation

Lautenschlager NT, Cox K, Kurz AF. Physical activity and mild cognitive impairment and Alzheimer's disease. Curr Neurol Neurosci Rep. 2010 Sep;10(5):352-8. doi: 10.1007/s11910-010-0121-7. Review. — View 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. Epub 2003 Aug 22. — View 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

Varela S, Cancela JM, Seijo-Martinez M, Ayán 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. — View Citation

Vogel T, Brechat PH, Leprêtre 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. Review. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Recruited Determine the feasibility of a future randomized controlled trial to evaluate the impact on balance and mobility of motivating reminiscence technology using the jDome BikeAround system for adults in long term care. Feasibility will be determined by the ability to recruit 30 residents (based on the LTC population base at The Glebe Centre). Baseline
Primary Protocol Adherence Determine the feasibility of a future randomized controlled trial to evaluate the impact on balance and mobility of motivating reminiscence technology using the jDome BikeAround system for adults in long term care. Feasibility will be determined by the number of residents to complied with the protocol during their respective campaign by using the jDome BikeAround system 3 times a week. Week 18
Primary Number of Participants Who Experience an Adverse Events While Using the jDome BikeAround (System) The number of adverse events while directly interacting with the jDome BikeAround system will be tracked to help determine feasibility of this kind of randomized trial. Week 18
Primary Performance Oriented Mobility Assessment The Performance Oriented Mobility Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks as either 0, 1 or 2 where a score of 0 represents the most impaired while a score of 2 represents independence. The total is calculated by adding the score for each individual activity, the lowest possible score is 0 and the highest possible score is 28. The higher the score the better the more mobile the participant is. This will give us a baseline value for the participants. Baseline
Primary Performance Oriented Mobility Assessment The Performance Oriented Mobility Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks as either 0, 1 or 2 where a score of 0 represents the most impaired while a score of 2 represents independence. The total is calculated by adding the score for each individual activity, the lowest possible score is 0 and the highest possible score is 28. The higher the score the better the more mobile the participant is. This measure will be taken after the first campaign has been completed. Week 6
Primary Performance Oriented Mobility Assessment The Performance Oriented Mobility Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks as either 0, 1 or 2 where a score of 0 represents the most impaired while a score of 2 represents independence. The total is calculated by adding the score for each individual activity, the lowest possible score is 0 and the highest possible score is 28. The higher the score the better the more mobile the participant is. This measure will be taken just before the second campaign is to begin. Week 12
Primary Performance Oriented Mobility Assessment The Performance Oriented Mobility Assessment Tool is a simple, easily administered test that measures a resident's gait and balance. The test is scored on the resident's ability to perform specific tasks as either 0, 1 or 2 where a score of 0 represents the most impaired while a score of 2 represents independence. The total is calculated by adding the score for each individual activity, the lowest possible score is 0 and the highest possible score is 28. The higher the score the better the more mobile the participant is. This measure will be taken after the second campaign has been completed. Week 18
Secondary 2 Minute Walk Test Distance participant can walk without assistance for 2 minutes measured from the starting position. Baseline
Secondary 2 Minute Walk Test Distance participant can walk without assistance for 2 minutes measured from the starting position. 6 Week
Secondary 2 Minute Walk Test Distance participant can walk without assistance for 2 minutes measured from the starting position. 12 Week
Secondary 2 Minute Walk Test Distance participant can walk without assistance for 2 minutes measured from the starting position. 18 Week
Secondary Knee Range of Motion Test Test that asses the range of motion of a participant's knee Baseline
Secondary Knee Range of Motion Test Test that asses the range of motion of a participant's knee 6 weeks
Secondary Knee Range of Motion Test Test that asses the range of motion of a participant's knee 12 weeks
Secondary Knee Range of Motion Test Test that asses the range of motion of a participant's knee 18 weeks