Virtual Reality-enhanced Exercise and Education in Cardiac Rehabilitation

Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945201
• Other study ID #: 17P.652
• Status: Completed
• Phase: N/A
• Start date: January 29, 2018
• Est. completion date: July 29, 2019

Study information

• Verified date: August 2019
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 29, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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.
• 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.

Locations

Country	Name	City	State
United States	Jefferson Health Methodist Cardiac Rehabilitation Program	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. Review. — View Citation

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2014;6:CD007131. — View Citation

Dithmer M, Rasmussen JO, Grönvall E, Spindler H, Hansen J, Nielsen G, Sørensen 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Vieira Á, 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Participant 6-minute Walk Test Improvement Between Control and Intervention Groups	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.	From date of enrollment through study completion, an average of 12 weeks
Secondary	Participant Satisfaction with Cardiac Rehab Treatment	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.	At completion of cardiac rehab treatment, an average of 12 weeks
Secondary	Participant Cardiac Education Retention	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.	At enrollment; at date of treatment completion, average of 12 weeks; two months following treatment completion