- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04043416
Reminiscence Technology Balance and Mobility
Using Motivating Reminiscence Technology to Encourage Physical Activity and Improve Balance and Mobility for Residents in Long Term Care
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1S 5A7
- The Glebe Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: System + Fall Prevention First, then Fall Prevention
Participants in this arm will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the first 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program. Following the 6 week washout period, the participants in this arm will just participate in the Fall Prevention program alone. Fall Prevention Program focuses on reducing the incidence of residents' falls and mitigating risks of falls through a resident focused, team approach which ensures that a resident's environment and social, physical, cognitive and emotional strengths are supported. This is an interdisciplinary program involving nursing and program staff, physician/pharmacist, dietician, physiotherapist, housekeeping staff and the resident/POA. They communicate regarding their planned interventions and evaluation of resident progress and outcomes in falls prevention through documentation. |
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.
Other Names:
|
Experimental: Fall Prevention first, then System +Fall Prevention
Participants in this arm will participate in the Fall Prevention program alone during the first 6 week campaign. Following the 6 week washout period the participants will be invited to use the jDome BikeAround system for up to 30 minute sessions up to 3 times a week during the second 6 week campaign. During this campaign the participants will also participant in the standard fall prevention program Fall Prevention Program focuses on reducing the incidence of residents' falls and mitigating risks of falls through a resident focused, team approach which ensures that a resident's environment and social, physical, cognitive and emotional strengths are supported. This is an interdisciplinary program involving nursing and program staff, physician/pharmacist, dietician, physiotherapist, housekeeping staff and the resident/POA. They communicate regarding their planned interventions and evaluation of resident progress and outcomes in falls prevention through documentation. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Recruited
Time Frame: Baseline
|
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
|
Protocol Adherence
Time Frame: Week 18
|
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
|
Number of Participants Who Experience an Adverse Events While Using the jDome BikeAround (System)
Time Frame: Week 18
|
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
|
Performance Oriented Mobility Assessment
Time Frame: Baseline
|
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
|
Performance Oriented Mobility Assessment
Time Frame: Week 6
|
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
|
Performance Oriented Mobility Assessment
Time Frame: Week 12
|
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
|
Performance Oriented Mobility Assessment
Time Frame: Week 18
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2 Minute Walk Test
Time Frame: Baseline
|
Distance participant can walk without assistance for 2 minutes measured from the starting position.
|
Baseline
|
2 Minute Walk Test
Time Frame: 6 Week
|
Distance participant can walk without assistance for 2 minutes measured from the starting position.
|
6 Week
|
2 Minute Walk Test
Time Frame: 12 Week
|
Distance participant can walk without assistance for 2 minutes measured from the starting position.
|
12 Week
|
2 Minute Walk Test
Time Frame: 18 Week
|
Distance participant can walk without assistance for 2 minutes measured from the starting position.
|
18 Week
|
Knee Range of Motion Test
Time Frame: Baseline
|
Test that asses the range of motion of a participant's knee
|
Baseline
|
Knee Range of Motion Test
Time Frame: 6 weeks
|
Test that asses the range of motion of a participant's knee
|
6 weeks
|
Knee Range of Motion Test
Time Frame: 12 weeks
|
Test that asses the range of motion of a participant's knee
|
12 weeks
|
Knee Range of Motion Test
Time Frame: 18 weeks
|
Test that asses the range of motion of a participant's knee
|
18 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark Campbell, MD, MSc, Bruyere Continuing Care
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- M16-19-012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adults Living in Long Term Care
-
University of the Basque Country (UPV/EHU)CompletedFrailty | Older Adults | Activities of Daily Living | Long Term CareSpain
-
Hospices Civils de LyonCompletedLong-term Parenteral Nutrition (2 Years) in Children and AdultsFrance
-
University of NottinghamCompletedPalliative Care | Long-Term CareUnited Kingdom
-
National Taiwan University HospitalCompletedLong-term CareTaiwan
-
National Taipei University of Nursing and Health...Recruiting
-
Indiana UniversityRecruitingPediatric Cancer | Long-term Effects Secondary to Cancer Therapy in AdultsUnited States
-
Cristina García-VivarInstituto de Salud Carlos IIINot yet recruitingLong-term Effects Secondary to Cancer Therapy in Adults | Long-term Effects of Cancer Treatment
-
Centre Francois BaclesseLigue contre le cancer, FranceRecruitingLong Term Cancer Side Effects | Supportive Care in Cancer | Cancer Survivorship Care Plan | Advanced Nurse Practitioner | Pelvic Gynecological CancerFrance
-
National Taipei University of Nursing and Health...Not yet recruitingGender | Empowerment | Long Term Care
Clinical Trials on Motivating reminiscence technology
-
Bruyere Research InstituteBruyere Academic Medical OrganizationRecruiting
-
Universidad Nacional de RosarioCompleted
-
Alexandria UniversityRecruiting
-
University of WashingtonNational Institute on Minority Health and Health Disparities (NIMHD)Withdrawn
-
Amasya UniversityThe Scientific and Technological Research Council of TurkeyNot yet recruiting
-
National Taipei University of Nursing and Health...Recruiting
-
University of Southern DenmarkVIA University College; Nørrebro Erindringscenter - the Danish Centre for ReminiscenceCompletedConsequences for Nursing Home Residents and Staff of Integrating Reminiscence Into Daily Nursing Care.Denmark
-
Oregon Health and Science UniversityUniversity of California, Davis; National Center for Advancing Translational... and other collaboratorsNot yet recruitingCognitive Decline | Cognitive Impairment, Mild
-
Samsung ElectronicsCompletedAged | Adults | Middle Age | Aged, 80 and OverKorea, Republic of
-
National Cheng-Kung University HospitalNational Science Council, TaiwanCompleted