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
• Sponsor: Thomas Jefferson University
• Information provided by (Responsible Party): Thomas Jefferson University

Tracking Information

• First Submitted Date: May 8, 2019
• First Posted Date: May 10, 2019
• Last Update Posted Date: August 2, 2019
• Actual Study Start Date: January 29, 2018
• Actual Primary Completion Date: May 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Virtual Reality-enhanced Exercise and Education in Cardiac Rehabilitation
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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

• Adherence, Patient
• Motivation
• Satisfaction

Intervention

• 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

• 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 *

• Ades PA, Keteyian SJ, Wright JS, Hamm LF, Lui K, Newlin K, Shepard DS, Thomas RJ. Increasing Cardiac Rehabilitation Participation From 20% to 70%: A Road Map From the Million Hearts Cardiac Rehabilitation Collaborative. Mayo Clin Proc. 2017 Feb;92(2):234-242. doi: 10.1016/j.mayocp.2016.10.014. Epub 2016 Nov 15.
• Davies P, Taylor F, Beswick A, Wise F, Moxham T, Rees K, Ebrahim S. Promoting patient uptake and adherence in cardiac rehabilitation. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD007131. doi: 10.1002/14651858.CD007131.pub2.
• Kerins M, McKee G, Bennett K. Contributing factors to patient non-attendance at and non-completion of Phase III cardiac rehabilitation. Eur J Cardiovasc Nurs. 2011 Mar;10(1):31-6. doi: 10.1016/j.ejcnurse.2010.03.006. Epub 2010 May 10.
• Mikkelsen T, Korsgaard Thomsen K, Tchijevitch O. Non-attendance and drop-out in cardiac rehabilitation among patients with ischaemic heart disease. Dan Med J. 2014 Oct;61(10):A4919.
• Vieira A, Gabriel J, Melo C, Machado J. Kinect system in home-based cardiovascular rehabilitation. Proc Inst Mech Eng H. 2017 Jan;231(1):40-47. doi: 10.1177/0954411916679201. Epub 2016 Dec 19.
• Dithmer M, Rasmussen JO, Gronvall E, Spindler H, Hansen J, Nielsen G, Sorensen SB, Dinesen B. "The Heart Game": Using Gamification as Part of a Telerehabilitation Program for Heart Patients. Games Health J. 2016 Feb;5(1):27-33. doi: 10.1089/g4h.2015.0001. Epub 2015 Nov 18.
• Lynggaard V, Nielsen CV, Zwisler AD, Taylor RS, May O. The patient education - Learning and Coping Strategies - improves adherence in cardiac rehabilitation (LC-REHAB): A randomised controlled trial. Int J Cardiol. 2017 Jun 1;236:65-70. doi: 10.1016/j.ijcard.2017.02.051. Epub 2017 Feb 21.
• Dankner R, Drory Y, Geulayov G, Ziv A, Novikov I, Zlotnick AY, Moshkovitz Y, Elami A, Schwammenthal E, Goldbourt U. A controlled intervention to increase participation in cardiac rehabilitation. Eur J Prev Cardiol. 2015 Sep;22(9):1121-8. doi: 10.1177/2047487314548815. Epub 2014 Sep 2.
• Shema SR, Brozgol M, Dorfman M, Maidan I, Sharaby-Yeshayahu L, Malik-Kozuch H, Wachsler Yannai O, Giladi N, Hausdorff JM, Mirelman A. Clinical experience using a 5-week treadmill training program with virtual reality to enhance gait in an ambulatory physical therapy service. Phys Ther. 2014 Sep;94(9):1319-26. doi: 10.2522/ptj.20130305. Epub 2014 May 1.
• Sloot LH, van der Krogt MM, Harlaar J. Effects of adding a virtual reality environment to different modes of treadmill walking. Gait Posture. 2014 Mar;39(3):939-45. doi: 10.1016/j.gaitpost.2013.12.005. Epub 2013 Dec 18.
• Meng K, Seekatz B, Haug G, Mosler G, Schwaab B, Worringen U, Faller H. Evaluation of a standardized patient education program for inpatient cardiac rehabilitation: impact on illness knowledge and self-management behaviors up to 1 year. Health Educ Res. 2014 Apr;29(2):235-46. doi: 10.1093/her/cyt107. Epub 2014 Jan 7.
• Gulick V, Graves D, Ames S, Krishnamani PP. Effect of a Virtual Reality-Enhanced Exercise and Education Intervention on Patient Engagement and Learning in Cardiac Rehabilitation: Randomized Controlled Trial. J Med Internet Res. 2021 Apr 15;23(4):e23882. doi: 10.2196/23882.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 8, 2019): 72
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: July 29, 2019
• Actual Primary Completion Date: May 31, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03945201
• Other Study ID Numbers: 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

• 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.

• Current Responsible Party: Thomas Jefferson University
• Original Responsible Party: Same as current
• Current Study Sponsor: Thomas Jefferson University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Thomas Jefferson University
• Verification Date: August 2019