Virtual Reality-enhanced Exercise and Education in Cardiac Rehabilitation

Not Applicable

Completed

• Conditions: Adherence, Patient; Motivation; Satisfaction
• Interventions: Other: Standard of care; Other: Virtual walking trails

• Registration Number: NCT03945201
• Lead Sponsor: Thomas Jefferson University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-29
• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-10
• Primary Completion: 2019-05-31
• Study Completion: 2019-07-29
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of care	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.
Virtual walking trails	Virtual walking trails	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Jefferson Health Methodist Cardiac Rehabilitation Program; 🇺🇸 Philadelphia, Pennsylvania, United States