Adherence, Patient, Motivation, Satisfaction
Conditions
Keywords
cardiac rehabilitation, virtual reality, VR, treadmill, education retention, patient education
Brief summary
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.
Interventions
OTHERVirtual walking trails
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.
OTHERStandard of care
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.
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Consent and enrollment process does not mention virtual reality to maintain blinding between control and intervention arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Participant 6-minute Walk Test Improvement Between Control and Intervention Groups | From date of enrollment through study completion, an average of 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction with Cardiac Rehab Treatment | At completion of cardiac rehab treatment, an average of 12 weeks | 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. |
| Participant Cardiac Education Retention | At enrollment; at date of treatment completion, average of 12 weeks; two months following treatment completion | 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. |
Countries
United States
Outcome results
None listed