Adults Living in Long Term CareNCT04043416
Reminiscence Technology Balance and Mobility
A study testing Motivating reminiscence technology in people with Adults Living in Long Term Care, run by Bruyère Health Research Institute. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adults Living in Long Term Care
- What is being tested?
- Motivating reminiscence technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 13 May 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Motivating Reminiscence Technology to Encourage Physical Activity and Improve Balance and Mobility for Residents in Long Term Care
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.
Read the 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.
- Conditions
- Adults Living in Long Term Care
- Being tested
- Motivating reminiscence technology
- Keywords
- Long Term Care, Motivating Reminiscence Technology, Feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivating reminiscence technologyOther
Also called jDome BikeAround System
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.
| Study group | Role | What they receive |
|---|---|---|
| System + Fall Prevention First, then Fall Prevention | Experimental | 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. Receives: Other: Motivating reminiscence technology |
| Fall Prevention first, then System +Fall Prevention | Experimental | 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. Receives: Other: Motivating reminiscence technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
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.
Measured: Week 18
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.
Measured: Week 18
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.
Measured: Baseline
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.
Measured: Week 6
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.
Measured: Week 12
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.
Measured: Week 18
Secondary outcomes (8)
2 Minute Walk Test
Distance participant can walk without assistance for 2 minutes measured from the starting position.
Measured: Baseline
2 Minute Walk Test
Distance participant can walk without assistance for 2 minutes measured from the starting position.
Measured: 6 Week
2 Minute Walk Test
Distance participant can walk without assistance for 2 minutes measured from the starting position.
Measured: 12 Week
2 Minute Walk Test
Distance participant can walk without assistance for 2 minutes measured from the starting position.
Measured: 18 Week
Knee Range of Motion Test
Test that asses the range of motion of a participant's knee
Measured: Baseline
Knee Range of Motion Test
Test that asses the range of motion of a participant's knee
Measured: 6 weeks
Knee Range of Motion Test
Test that asses the range of motion of a participant's knee
Measured: 12 weeks
Knee Range of Motion Test
Test that asses the range of motion of a participant's knee
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start13 May 2019
- Primary completion18 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Adults Living in Long Term CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruyère Health Research Institute.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Campbell, Bruyère Health Research Institute.
- Investigators
- Mark Campbell, MD, MSc, Principal investigator, Bruyere Continuing Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043416
- Sponsor's protocol ID
- M16-19-012
- Status last verified
- Jul 2020
- First submitted
- 30 Jul 2019
- Last updated
- 7 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be making IPD available to other researchers.
Publications
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.
PubMed 20556547Vogel 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.
PubMed 19196369Menne 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.
PubMed 23434919de 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.
PubMed 29755934Varela 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.
PubMed 29431549Batcir 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.
PubMed 29345533Harvey 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.
PubMed 29182418Macaluso 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.
PubMed 12937026Huang 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.
PubMed 26341034Karssemeijer 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.
PubMed 28912076
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Motivating Reminiscence Technology to Encourage Physical Activity and Improve Balance and Mobility for Residents in Long Term Care
- ClinicalTrials.gov ID
- NCT04043416
- Acronym / sponsor ID
- M16-19-012
- Conditions
- Adults Living in Long Term Care
- Keywords
- Long Term Care, Motivating Reminiscence Technology, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Bruyère Health Research Institute.University, hospital or other
- Study start
- 13 May 2019 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Posted 21 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| System + Fall Prevention First, then Fall Prevention | Experimental | Other: Motivating reminiscence technologyParticipants 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. |
| Fall Prevention first, then System +Fall Prevention | Experimental | Other: Motivating reminiscence technologyParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivating reminiscence technologyAlso: jDome BikeAround SystemThe 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 | Fall Prevention first, then System +Fall Prevention, System + Fall Prevention First, then Fall Prevention |
Primary outcome
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).
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.
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.
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.
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.
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.
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.
8 secondary outcomes
2 Minute Walk Test
Time frame: Baseline
2 Minute Walk Test
Time frame: 6 Week
2 Minute Walk Test
Time frame: 12 Week
2 Minute Walk Test
Time frame: 18 Week
Knee Range of Motion Test
Time frame: Baseline
Knee Range of Motion Test
Time frame: 6 weeks
Knee Range of Motion Test
Time frame: 12 weeks
Knee Range of Motion Test
Time frame: 18 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20556547Lautenschlager 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.
- Background: PubMed 19196369Vogel 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.
- BackgroundMenne 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
- Background: PubMed 23434919Benjamin 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.
- Background: PubMed 29755934de 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.
- Background: PubMed 29431549Varela 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.
- Background: PubMed 29345533Batcir 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.
- Background: PubMed 29182418Harvey 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.
- Background: PubMed 12937026Macaluso 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.
- Background: PubMed 26341034Huang 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.
- Background: PubMed 28912076Karssemeijer 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.
- Individual participant dataSharing planned: No. We will not be making IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Campbell, MD, MSc principal investigator
Bruyere Continuing Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivating reminiscence technology in people with Adults Living in Long Term Care, run by Bruyère Health Research Institute. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Recruited (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04043416, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.