Clinical trial NCT05381571: Integrating Reminiscence Technology Into Exercise Programs in Subacute Care
Official title: Integrating Reminiscence Technology Into Exercise Programs in Subacute Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rehabilitation
Keywords: Motivating Reminiscence Technology
Feasibility
Exercise Adherence
Lead sponsor: Bruyere Research Institute
Sponsor class: OTHER
Collaborators: name: Bruyere Academic Medical Organization
First posted: 2022-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All recruited participants will use the reminiscence based physical therapy technology, three times weekly for a total of 12 weeks (average admission duration). The expected study enrolment period is 6 months to allow for multiple sets of participants to be recruited from the same medical unit.
Primary purpose: TREATMENT

Brief summary: This study evaluates the feasibility of a randomized controlled trial to evaluate the impact of motivating reminiscence-based therapy on exercise adherence, mood and physical health within a subacute rehabilitation population. The jDome BikeAround technology displays user-specified Google Earth images onto a domed screen as the user pedals on a stationary bike, which fosters the experience of bicycling through that given environment. Participants will use the technology for 12 weeks during their regularly scheduled therapy sessions.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Participant Recruitment
timeFrame: Baseline
measure: Number of participants retained
timeFrame: Week 12
measure: Rate of adverse events
timeFrame: Week 12
measure: Staff Acceptance
timeFrame: Week 12
Secondary outcomes:
measure: Endurance
timeFrame: 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
measure: Mood changes
timeFrame: Weekly after a jDome BikeAround session (for 12 weeks)
measure: Functional Independence Measure (FIM score)
timeFrame: Baseline, week 6, week 12
measure: Satisfaction using jDome BikeAround - Participants
timeFrame: Baseline, week 6, week 12
measure: Satisfaction using jDome BikeAround - Staff
timeFrame: Baseline, week 6, week 12
measure: Emotional Impact
timeFrame: Baseline, week 6, week 12
measure: Impact on overall therapy experience - Participants
timeFrame: Baseline, week 6, week 12
measure: Impact on overall therapy experience - Staff
timeFrame: Baseline, week 6, week 12
measure: Ease of instruction - Participants
timeFrame: Baseline, week 6, week 12
measure: Ease of instruction - Staff
timeFrame: Baseline, week 6, week 12
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Saint-Vincent Hospital
state: Ontario
Study officials:
References:
citation: Hay Group, HCC. Sub-Acute Care Capacity Plan. 2016.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Howe TE, Rochester L, Neil F, Skelton DA, Ballinger C. Exercise for improving balance in older people. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD004963. doi: 10.1002/14651858.CD004963.pub3.
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: American College of Sports Medicine Position Stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 1998 Jun;30(6):992-1008.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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: 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.
citation: 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.
citation: 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.