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Completed

NCT Number: NCT03945201

Virtual Reality-enhanced Exercise and Education in Cardiac Rehabilitation

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.

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Key information

Conditions

Adherence, Patient Behavior Health Behavior Motivation Patient Acceptance of Health Care Patient Compliance Personal Satisfaction Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jefferson Health Methodist Cardiac Rehabilitation Program

Philadelphia, Pennsylvania, 19145, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual walking trails

Other

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

Standard of care

Other

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 10, 2019
Registry last updated
Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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