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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05381571
Other study ID # Bruyere
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 2023
Est. completion date April 2024

Study information

Verified date February 2023
Source Bruyere Research Institute
Contact Mark Campbell, MD, MSc
Phone 613-562-6262
Email tcampbell@bruyere.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Motivating reminiscence physical therapy
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.

Locations

Country Name City State
Canada Saint-Vincent Hospital Ottawa Ontario

Sponsors (2)

Lead Sponsor Collaborator
Bruyere Research Institute Bruyere Academic Medical Organization

Country where clinical trial is conducted

Canada, 

References & Publications (20)

American College of Sports Medicine Position Stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 1998 Jun;30(6):992-1008. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Hay Group, HCC. Sub-Acute Care Capacity Plan. 2016.

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. — 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

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 20 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Participant Recruitment 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). Baseline
Primary Number of participants retained 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. Week 12
Primary Rate of adverse events 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. Week 12
Primary Staff Acceptance 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). Week 12
Secondary Endurance Total distance (meters) travelled during each jDome BikeAround therapy bike session. 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
Secondary Mood changes Participant mood changes will be measured following their jDome BikeAround session using The Face Scale developed by Lorish and Maisiak (1986) Weekly after a jDome BikeAround session (for 12 weeks)
Secondary Functional Independence Measure (FIM score) 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). Baseline, week 6, week 12
Secondary Satisfaction using jDome BikeAround - Participants This measure will be assessed using semi-structured interviews Baseline, week 6, week 12
Secondary Satisfaction using jDome BikeAround - Staff This measure will be assessed using online surveys for rehabilitation staff. 5-point scale from "strongly disagree, disagree, neutral, agree, strongly agree" Baseline, week 6, week 12
Secondary Emotional Impact This measure will be assessed using semi-structured interviews with participants. This will assessed depending on participant verbal responses, not using any particular scale. Baseline, week 6, week 12
Secondary Impact on overall therapy experience - Participants This measure will be assessed using semi-structured interviews with participants Baseline, week 6, week 12
Secondary Impact on overall therapy experience - Staff This measure will be assessed using online surveys for rehabilitation staff. 5-point scale from "strongly disagree, disagree, neutral, agree, strongly agree" Baseline, week 6, week 12
Secondary Ease of instruction - Participants This measure will be assessed using semi-structured interviews with participants Baseline, week 6, week 12
Secondary Ease of instruction - Staff 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" Baseline, week 6, week 12
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