- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05381571
Integrating Reminiscence Technology Into Exercise Programs in Subacute Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adherence to physical activity in older adults and those in a low-intensity rehabilitation program is important with respect to achieving the demonstrated benefits in mobility, physical function and overall health maintenance. Physical activities that incorporate motivational strategies can improve long-term adherence to therapy programs. The jDome BikeAround technology is one example, as it involves reminiscence therapy coupled with stationary bicycling. Participant's are able to visit any familiar locations or places they have wished to visit, thus providing a positive and interactive experience as they engage in physical activity.
Participants will be enrolled for a total of 12 weeks. They will have three 10 minute weekly sessions with the jDome BikeAround during their regularly scheduled therapy sessions. Feasibility will be evaluated by participant recruitment, program completion, rate of adverse events and staff acceptance.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1R 7A5
- Recruiting
- Saint-Vincent Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Admitted to the LIR (Low-intensity rehabilitation) or CMP (complex medical program) unit/floor where the research study is being conducted. Of note, both units receive low intensity rehabilitation services at baseline.
- Participants capable of providing informed consent or have a SDM capable of providing consent on their behalf
- Sufficient visual abilities to observe images on the domed screen
- Able to comprehend and communicate in English or French
- 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 SVH healthcare/physiotherapy team) that prevent use of the jDome BikeAround. This includes:
- 1) Inability to coordinate/move lower limbs effectively to complete pedaling task
- 2) The pedaling exercise causes discomfort/pain greater than expected with physical activity
- 3) Medical treatment prevents usage of the system (i.e. continuous ventilatory needs for patients admitted within the CMP unit)
- Cognitive impairment (as determined by the SVH healthcare/physiotherapy team) that prevent use of the jDome BikeAround, such as:
- 1) Inability to sustain attention to focus on pedaling task
- 2) Inability to follow one-step commands.
- Known behavioral 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, the attending physician or clinical team, too unwell to participate in the project
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reminiscence-based physical therapy
Participants will use the reminiscence-based technology (jDome BikeAround) for 10-minute sessions for three times per week during the 12 week study enrolment period.
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The jDome BikeAround system involves participants using a stationary bike while their selected location is displayed in front of them on a domed projector screen using Google Street View.
Using pedals on the bike they can propel themselves down the street, steer and change direction as they wish.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant Recruitment
Time Frame: Baseline
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Determine the feasibility of a future randomized controlled trial to evaluate the impact of the jDome BikeAround system on exercise adherence, mood and physical health within a subacute rehabilitation population.
Feasibility will be determined by the ability to recruit 60 participants (based on the average number of patients admitted to the rehab units).
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Baseline
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Number of participants retained
Time Frame: Week 12
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Determine the feasibility of a future randomized controlled trial to evaluate the impact of the jDome BikeAround system on exercise adherence, mood and physical health within a subacute rehabilitation population.
Feasibility will be determined by the number of sessions participants attended, out of the total number of sessions offered.
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Week 12
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Rate of adverse events
Time Frame: Week 12
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The number of adverse events experienced by participants related to the use of the jDome BikeAround will be monitored to evaluate the feasibility of a future randomized controlled trial using this technology.
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Week 12
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Staff Acceptance
Time Frame: Week 12
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Staff Acceptance will be determined by measuring the number of sessions staff assign participants to use the jDome BikeAround, out of their total number of therapy sessions (I.e. total sessions assigned to use jDome BikeAround out of total therapy sessions which is 3 weekly sessions x 12 weeks).
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Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endurance
Time Frame: Total distance (meters) will be measured after each participant session (10 minutes) using the jDome BikeAround. This will occur 3 times per week throughout study duration for 12 weeks
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Total distance (meters) travelled during each jDome BikeAround therapy bike session.
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Total distance (meters) will be measured after each participant session (10 minutes) using the jDome BikeAround. This will occur 3 times per week throughout study duration for 12 weeks
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Mood changes
Time Frame: Weekly after a jDome BikeAround session (for 12 weeks)
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Participant mood changes will be measured following their jDome BikeAround session using The Face Scale developed by Lorish and Maisiak (1986)
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Weekly after a jDome BikeAround session (for 12 weeks)
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Functional Independence Measure (FIM score)
Time Frame: Baseline, week 6, week 12
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Standardized measure of disability used in rehabilitation populations.
Measure evaluating 18 functional tasks on a scale of 1 (total care) to 7 (independent).
Maximum 126 (best) and minimum is 18 (worst).
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Baseline, week 6, week 12
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Satisfaction using jDome BikeAround - Participants
Time Frame: Baseline, week 6, week 12
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This measure will be assessed using semi-structured interviews
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Baseline, week 6, week 12
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Satisfaction using jDome BikeAround - Staff
Time Frame: Baseline, week 6, week 12
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This measure will be assessed using online surveys for rehabilitation staff.
5-point scale from "strongly disagree, disagree, neutral, agree, strongly agree"
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Baseline, week 6, week 12
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Emotional Impact
Time Frame: Baseline, week 6, week 12
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This measure will be assessed using semi-structured interviews with participants.
This will assessed depending on participant verbal responses, not using any particular scale.
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Baseline, week 6, week 12
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Impact on overall therapy experience - Participants
Time Frame: Baseline, week 6, week 12
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This measure will be assessed using semi-structured interviews with participants
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Baseline, week 6, week 12
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Impact on overall therapy experience - Staff
Time Frame: Baseline, week 6, week 12
|
This measure will be assessed using online surveys for rehabilitation staff.
5-point scale from "strongly disagree, disagree, neutral, agree, strongly agree"
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Baseline, week 6, week 12
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Ease of instruction - Participants
Time Frame: Baseline, week 6, week 12
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This measure will be assessed using semi-structured interviews with participants
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Baseline, week 6, week 12
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Ease of instruction - Staff
Time Frame: Baseline, week 6, week 12
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This measure will be assessed using online surveys for rehabilitation staff.
3 questions graded on a 5-point scale from "strongly disagree, disagree, neutral, agree, strongly agree"
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Baseline, week 6, week 12
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Hay Group, HCC. Sub-Acute Care Capacity Plan. 2016.
- Foley N, McClure JA, Meyer M, Salter K, Bureau Y, Teasell R. Inpatient rehabilitation following stroke: amount of therapy received and associations with functional recovery. Disabil Rehabil. 2012;34(25):2132-8. doi: 10.3109/09638288.2012.676145. Epub 2012 Apr 23.
- Dijkers MP, Zanca JM. Factors complicating treatment sessions in spinal cord injury rehabilitation: nature, frequency, and consequences. Arch Phys Med Rehabil. 2013 Apr;94(4 Suppl):S115-24. doi: 10.1016/j.apmr.2012.11.047. Epub 2013 Mar 7.
- de Souto Barreto P, Rolland Y, Vellas B, Maltais M. Association of Long-term Exercise Training With Risk of Falls, Fractures, Hospitalizations, and Mortality in Older Adults: A Systematic Review and Meta-analysis. JAMA Intern Med. 2019 Mar 1;179(3):394-405. doi: 10.1001/jamainternmed.2018.5406.
- Howe TE, Rochester L, Neil F, Skelton DA, Ballinger C. Exercise for improving balance in older people. Cochrane Database Syst Rev. 2011 Nov 9;(11):CD004963. doi: 10.1002/14651858.CD004963.pub3.
- 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.
- American College of Sports Medicine Position Stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 1998 Jun;30(6):992-1008.
- Ruano-Ravina A, Pena-Gil C, Abu-Assi E, Raposeiras S, van 't Hof A, Meindersma E, Bossano Prescott EI, Gonzalez-Juanatey JR. Participation and adherence to cardiac rehabilitation programs. A systematic review. Int J Cardiol. 2016 Nov 15;223:436-443. doi: 10.1016/j.ijcard.2016.08.120. Epub 2016 Aug 13.
- Bredland EL, Soderstrom S, Vik K. Challenges and motivators to physical activity faced by retired men when ageing: a qualitative study. BMC Public Health. 2018 May 15;18(1):627. doi: 10.1186/s12889-018-5517-3.
- Schutzer KA, Graves BS. Barriers and motivations to exercise in older adults. Prev Med. 2004 Nov;39(5):1056-61. doi: 10.1016/j.ypmed.2004.04.003.
- Bennett JA, Winters-Stone K. Motivating older adults to exercise: what works? Age Ageing. 2011 Mar;40(2):148-9. doi: 10.1093/ageing/afq182. Epub 2011 Jan 20. No abstract available.
- D'Cunha NM, Isbel ST, Frost J, Fearon A, McKune AJ, Naumovski N, Kellett J. Effects of a virtual group cycling experience on people living with dementia: A mixed method pilot study. Dementia (London). 2021 Jul;20(5):1518-1535. doi: 10.1177/1471301220951328. Epub 2020 Aug 21.
- 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.
- Cheng C, Fan W, Liu C, Liu Y, Liu X. Reminiscence therapy-based care program relieves post-stroke cognitive impairment, anxiety, and depression in acute ischemic stroke patients: a randomized, controlled study. Ir J Med Sci. 2021 Feb;190(1):345-355. doi: 10.1007/s11845-020-02273-9. Epub 2020 Jun 23.
- Batchelor-Aselage M, Amella E, Zapka J, Mueller M, Beck C. Research with dementia patients in the nursing home setting: a protocol for informed consent and assent. IRB. 2014 Mar-Apr;36(2):14-20. No abstract available.
- Laddu DR, Lavie CJ, Phillips SA, Arena R. Physical activity for immunity protection: Inoculating populations with healthy living medicine in preparation for the next pandemic. Prog Cardiovasc Dis. 2021 Jan-Feb;64:102-104. doi: 10.1016/j.pcad.2020.04.006. Epub 2020 Apr 9. No abstract available.
- Lin YC, Dai YT, Hwang SL. The effect of reminiscence on the elderly population: a systematic review. Public Health Nurs. 2003 Jul-Aug;20(4):297-306. doi: 10.1046/j.1525-1446.2003.20407.x.
- Rivera-Torres S, Fahey TD, Rivera MA. Adherence to Exercise Programs in Older Adults: Informative Report. Gerontol Geriatr Med. 2019 Jan 22;5:2333721418823604. doi: 10.1177/2333721418823604. eCollection 2019 Jan-Dec.
- Mora JC, Valencia WM. Exercise and Older Adults. Clin Geriatr Med. 2018 Feb;34(1):145-162. doi: 10.1016/j.cger.2017.08.007. Epub 2017 Oct 10.
- Lorish CD, Maisiak R. The Face Scale: a brief, nonverbal method for assessing patient mood. Arthritis Rheum. 1986 Jul;29(7):906-9. doi: 10.1002/art.1780290714.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- Bruyere
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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