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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

Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date August 2, 2019
Actual Study Start Date  ICMJE January 29, 2018
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03945201 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virtual Reality-enhanced Exercise and Education in Cardiac Rehabilitation
Official Title  ICMJE Effect of a Virtual Reality-enhanced Exercise and Education Intervention on Patient Engagement and Learning in Cardiac Rehabilitation
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Adherence, Patient
  • Motivation
  • Satisfaction
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Standard of care
  • 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.
    Intervention: Other: Virtual walking trails
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2019)
72
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 29, 2019
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945201
Other Study ID Numbers  ICMJE 17P.652
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Thomas Jefferson University
Study Sponsor  ICMJE Thomas Jefferson University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Thomas Jefferson University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP