Integrating Reminiscence Technology Into Exercise Programs in Subacute Care

Rehabilitation Clinical Trial

Official title:

Integrating Reminiscence Technology Into Exercise Programs in Subacute Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05381571
• Other study ID #: Bruyere
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Rehabilitation

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)

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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

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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

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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

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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

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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

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* Note: There are 20 references in all — Click 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