Virtual Reality-enhanced Exercise and Education in Cardiac Rehabilitation

NCT ID: NCT03945201

Last Updated: 2019-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-29

Study Completion Date

2019-07-29

Brief Summary

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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

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Conditions

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Adherence, Patient Motivation Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Consent and enrollment process does not mention virtual reality to maintain blinding between control and intervention arms.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Virtual walking trails

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Bionautica Trails

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jefferson Health Methodist Cardiac Rehabilitation Program

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27855953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20614453 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20457543 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25283618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27913628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26579590 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28259552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25183694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24786944 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24412269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24399262 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33856355 (View on PubMed)

Other Identifiers

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17P.652

Identifier Type: -

Identifier Source: org_study_id

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