Clinical trial NCT03945201: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence, Patient
Motivation
Satisfaction
Keywords: cardiac rehabilitation
virtual reality
VR
treadmill
education retention
patient education
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Comparison of Participant 6-minute Walk Test Improvement Between Control and Intervention Groups
timeFrame: From date of enrollment through study completion, an average of 12 weeks
Secondary outcomes:
measure: Participant Satisfaction with Cardiac Rehab Treatment
timeFrame: At completion of cardiac rehab treatment, an average of 12 weeks
measure: Participant Cardiac Education Retention
timeFrame: At enrollment; at date of treatment completion, average of 12 weeks; two months following treatment completion
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Jefferson Health Methodist Cardiac Rehabilitation Program
state: Pennsylvania
Study officials:
References:
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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.
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.
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.
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.
citation: 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.