Virtual Reality-enhanced Exercise and Education in Cardiac Rehabilitation

Study Overview
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Brief Summary
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This study incorporates a virtual reality (VR) simulated walking environment, with audio component of patient education, into the treadmill portion of outpatient cardiac rehabilitation (CR). The VR program was developed by Plas.MD and is named Bionautica Trails.

Official Title
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Effect of a Virtual Reality-enhanced Exercise and Education Intervention on Patient Engagement and Learning in Cardiac Rehabilitation

Conditions
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Adherence, Patient, Motivation, Satisfaction

Intervention / Treatment
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* Other: Virtual walking trails
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must independently choose or be referred to Jefferson Health Methodist Cardiac Rehabilitation Program for outpatient cardiac rehabilitation. Participants must have a referring cardiac condition requiring cardiac rehabilitation therapy. Exclusion Criteria: Physical inability to use treadmill Medically unsafe to use a treadmill for 15 minutes Inability to understand English Unable to provide consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>Participants receive normal cardiac rehabilitation according to approved standard of care. They use multiple pieces of exercise equipment at each session for increasing amounts of time and at incrementally increasing levels of difficulty. After establishing a baseline, participants are allowed to use the treadmill for up to 15 minutes at each session. | Other: Standard of care<br>* Participants receive normal standard of care cardiac rehabilitation, completing multiple pieces of exercise equipment at increasing intervals according to the Jefferson Methodist Cardiac Rehabilitation program's protocols. Participants are given the option to use the treadmill for up to 15 minutes.<br>|
| Experimental: Virtual walking trails<br>Participants use multiple pieces of exercise equipment at each session for increasing amounts of time and at incrementally increasing levels of difficulty. After establishing a baseline, participants are allowed to use the treadmill for up to 15 minutes at each session. The treadmill is positioned in front of a vertically oriented high definition television screen showing Bionautica Trails, virtual walking trails created by Plas.md. | Other: Virtual walking trails<br>* During time on the treadmill, participants walk in front of Bionautica Trails, the virtual walking trails created by Plas.md. Participants can select between seven trails including various nature themed trails and a space setting. While walking, participants wear wireless headphones that provide audio of cardiac rehabilitation education at random intervals. These education pieces cover six categories of information: Understanding Your Heart Condition, Diet, Exercise, Medication, Managing Risk Factors, and Emotional Health.<br>* Other names: Bionautica Trails;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Participant 6-minute Walk Test Improvement Between Control and Intervention Groups | Each participant will complete a 6MWT at both their first and last cardiac rehab treatment sessions. Distance improvement between first and last treatment session is expected for all participants. Average distance improvement (measured in feet) between study arms will be compared to evaluate effectiveness of interventions. | From date of enrollment through study completion, an average of 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Satisfaction with Cardiac Rehab Treatment | All participants are asked to complete a satisfaction survey, utilizing likert scales and location specific questions to evaluate their satisfaction with treatment. Questions delineate the differences between experiences part of standard of care and those specific to the trial. | At completion of cardiac rehab treatment, an average of 12 weeks | 
| Participant Cardiac Education Retention | Participants will complete a brief, 5-question, education quiz at several times throughout their rehabilitation treatment. The quiz will be administered to establish a baseline of their cardiac knowledge prior to treatment, at the end of their treatment to evaluate primary comprehension, and again after treatment to evaluate longterm retention of information. Quiz scores and trends will be compared between study arms. | At enrollment; at date of treatment completion, average of 12 weeks; two months following treatment completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac rehabilitation, virtual reality, VR, treadmill, education retention, patient education