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Improving adherence to rehabilitation for heart failure patients through immersive virtual reality (VIRTUAL-HF): A protocol for a randomized controlled trial

V. Micheluzzi, G. Casu, G. Sanna, A. Canu, P. Iovino, G. Caggianelli, E. Vellone

Contemporary Clinical Trials, 2024

80 participants · 24 citations

Abstract

BACKGROUND

To improve symptoms and reduce poor outcomes related to heart failure (HF), international guidelines recommend cardiac rehabilitation (CR), particularly for those with a reduced ejection fraction. Unfortunately, patient adherence to rehabilitation programs remains suboptimal, with dropouts ranging from 15.4 to 63.3%. An innovative and promising intervention that could improve adherence to rehabilitation is virtual reality (VR). This study aims to evaluate the effects of VR in patients with HF who undergo CR using this technology in terms of adherence (primary outcome), functional capacity, perceived exertion, angina, quality of life, heart rate, oxygen saturation, blood pressure, maximum oxygen uptake, minute ventilation/carbon dioxide production slope, oxygen pulse, blood values of NT-proBNP and HF related rehospitalization rates (secondary outcomes).

METHODS

A randomized controlled trial will be conducted in a sample of 80 patients referred to CR. Participants will be enrolled in a cardiological rehabilitation unit of a large university hospital in Italy and randomized (1:1) to the experimental intervention consisting of CR performed with high-quality immersive VR with PICO 4® Head Mounted Display headset and TREADMILL XR® software (Arm 1) or standard CR (Arm 2). Patients, according to guidelines, will perform 30-min of CR sessions with moderate intensity, twice a week for one month.

RESULTS

Significant improvements in primary and secondary outcomes are expected…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 80 participants or records.

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