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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.

Virtual Reality-enhanced Exercise and Education in Cardiac Rehabilitation

Clinicaltrials.gov identifier NCT03945201

Recruitment Status Completed

First Posted May 10, 2019

Last update posted August 2, 2019

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:Adherence, Patient
    Motivation
    Satisfaction
  • Intervention/Treatment: Other: Virtual walking trails
    Other: Standard of care
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 72 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • 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 2018
  • Actual Primary Completion Date: May 2019
  • Actual Study Completion Date: July 2019
Arms and interventions
Arm Intervention/treatment
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.
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.
Outcome Measures
  • 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
  • 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
Contacts
Locations

United States, Pennsylvania
Jefferson Health Methodist Cardiac Rehabilitation Program
Philadelphia

Sponsors and Collaborators

Thomas Jefferson University

More Information