What is the clinical evidence from this study?

Study design: RCT. Population: Cardiac rehabilitation (n=72). Intervention: Virtual reality (VR) walking trails with audio-recorded education vs. Standard of care cardiac rehabilitation. Primary outcome: 6-minute walk test (6MWT) improvement (95% CI -224.14 to 139.52, p=0.64).

March 16, 2021Open Access

Effect of a Virtual Reality–Enhanced Exercise and Education Intervention on Patient Engagement and Learning in Cardiac Rehabilitation: Randomized Controlled Trial

Key Result

A virtual reality-enhanced exercise and education intervention did not significantly improve 6-minute walk test distances compared to standard of care in patients undergoing cardiac rehabilitation.

Study Design

Type

RCT (n=72)

Blinding

Open-label

Randomization

Google random number generator

Multicenter

Structured PICO

Does a virtual reality-enhanced exercise and education intervention improve 6-minute walk test distance and patient engagement in cardiac rehabilitation patients?

Population

72 adult patients undergoing cardiac rehabilitation, capable of independent treadmill use, followed for 18 to 36 treatment sessions.

Intervention

Virtual reality (VR) walking trails (Bionautica Trails) with audio-recorded cardiac education during treadmill exercise (up to 15 minutes per session), added to standard of care cardiac rehabilitation.

Comparator

Standard of care cardiac rehabilitation, including standard treadmill exercise (up to 15 minutes per session) and standard education via handouts, bulletin boards, and group lectures.

Outcome

Improvement in 6-minute walk test (6MWT) distance between prerehabilitation and postrehabilitation.surrogate

The addition of virtual reality walking trails to standard cardiac rehabilitation did not significantly improve 6-minute walk test distance, knowledge retention, or satisfaction, and was associated with lower attendance rates compared to standard care.

Main Result

Absolute Event Rate: 340% vs 298%

p-value: p=0.64

Limitations

44% of patients did not complete a post-6MWT, severely limiting the sample size.
The 6MWT used patient-initiated walking speed rather than the manual speed of the treadmills.
The knowledge retention test was limited to only 5 questions, which may have been too simplistic.
Neither patients nor onsite study staff could be blinded to the study arm.

Abstract

BACKGROUND: Cardiac rehabilitation (CR) is clinically proven to reduce morbidity and mortality; however, many eligible patients do not enroll in treatment. Furthermore, many enrolled patients do not complete their full course of treatment. This is greatly influenced by socioeconomic factors but is also because of patients' lack of understanding of the importance of their care and a lack of motivation to maintain attendance. OBJECTIVE: This study aims to explore the potential benefits of virtual reality (VR) walking trails within CR treatment, specifically with regard to patient knowledge retention, satisfaction with treatment, and the overall attendance of treatment sessions. METHODS: New CR patients were enrolled and randomized on a rolling basis to either the control group or intervention group. Intervention patients completed their time on the treadmill with VR walking trails, which included audio-recorded education, whereas control patients completed the standard of care therapy. Both groups were assisted by nursing staff for all treatment sessions. Primary outcomes were determined by assessing 6-minute walk test improvement. In addition, secondary outcomes of patients' cardiac knowledge and satisfaction were assessed via a computer-based questionnaire; patient adherence to the recommended number of sessions was also monitored. Cardiac knowledge assessment included a prerehabilitation education quiz, and the same quiz was repeated at patients' final visit and again at the 2-month follow-up. The satisfaction questionnaire was completed at the final visit. RESULTS: Between January 2018 and May 2019, 72 patients were enrolled-41 in the intervention group and 31 in the control group. On the basis of the results of the prerehabilitation and postrehabilitation 6-minute walk test, no significant differences were observed between the intervention and control groups (P=.64). No statistical differences were observed between groups in terms of education (P=.86) or satisfaction (P=.32) at any time point. The control group had statistically more favorable rates of attendance, as determined by the risk group comparison (P=.02) and the comparison of the rates for completing the minimum number of sessions (P=.046), but no correlation was observed between the study group and reasons for ending treatment. CONCLUSIONS: Although no improvements were seen in the VR intervention group over the control group, it is worth noting that limitations in the study design may have influenced these outcomes, not the medium itself. Furthermore, the qualitative information suggests that patients may have indeed enjoyed their experience with VR, even though quantitative satisfaction data did not capture this. Further considerations for how and when VR should be applied to CR are suggested in this paper. TRIAL REGISTRATION: ClinicalTrials.gov NCT03945201; https://clinicaltrials.gov/ct2/show/NCT03945201.

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