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Virtual Reality-enhanced Exercise and Education in Cardiac Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03945201
Recruitment Status : Completed
First Posted : May 10, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adherence, Patient Motivation Satisfaction Other: Virtual walking trails Other: Standard of care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Consent and enrollment process does not mention virtual reality to maintain blinding between control and intervention arms.
Primary Purpose: Other
Official Title: Effect of a Virtual Reality-enhanced Exercise and Education Intervention on Patient Engagement and Learning in Cardiac Rehabilitation
Actual Study Start Date : January 29, 2018
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : July 29, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Other: Standard 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.
Experimental: 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.
 Other: Virtual 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.
Other Name: Bionautica Trails


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of Participant 6-minute Walk Test Improvement Between Control and Intervention Groups [ Time Frame: 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 :
  1. Participant Satisfaction with Cardiac Rehab Treatment [ Time Frame: 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.

  2. Participant Cardiac Education Retention [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945201


Locations
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United States, Pennsylvania
Jefferson Health Methodist Cardiac Rehabilitation Program
Philadelphia, Pennsylvania, United States, 19145
Sponsors and Collaborators
Thomas Jefferson University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03945201    
Other Study ID Numbers: 17P.652
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified participant data will be made available for all gathered data, including primary and secondary outcomes, by request.
Supporting Materials: Study Protocol
Time Frame: Data will be available by request indefinitely.
Access Criteria: Data will be available by request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Jefferson University:
cardiac rehabilitation
virtual reality
VR
 treadmill
education retention
patient education