Virtual Reality-enhanced Exercise and Education in Cardiac Rehabilitation

Sponsor
Thomas Jefferson University (Other)
Overall Status
Completed
CT.gov ID
NCT03945201
Collaborator
(none)
72
1
2
17.9
4

Study Details

Study Description

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
  • Other: Virtual walking trails
  • Other: Standard of care
N/A

Study Design

Study Type:
Interventional
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 :
Jan 29, 2018
Actual Primary Completion Date :
May 31, 2019
Actual Study Completion Date :
Jul 29, 2019

Arms and Interventions

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 Names:
  • Bionautica Trails
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jefferson Health Methodist Cardiac Rehabilitation Program Philadelphia Pennsylvania United States 19145

    Sponsors and Collaborators

    • Thomas Jefferson University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT03945201
    Other Study ID Numbers:
    • 17P.652
    First Posted:
    May 10, 2019
    Last Update Posted:
    Aug 2, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Thomas Jefferson University

    Study Results

    No Results Posted as of Aug 2, 2019