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通过沉浸式虚拟现实(VIRTUAL-HF)提高心力衰竭患者康复治疗的依从性:一项随机对照试验方案。

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

机构信息

Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy; Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy.

Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy; Department of Medicine, and Pharmacy, University of Sassari, Sassari, Italy.

出版信息

Contemp Clin Trials. 2024 Mar;138:107463. doi: 10.1016/j.cct.2024.107463. Epub 2024 Jan 30.

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 in patients in the intervention group.

CONCLUSIONS

If proven to be effective, VR could be an innovative, safe, and easy digital health intervention to improve adherence to CR in patients with HF, as well as important clinical outcomes.

摘要

背景

为改善心力衰竭(HF)相关症状和降低不良预后,国际指南推荐心脏康复(CR),尤其适用于射血分数降低的患者。然而,患者对康复计划的依从性仍然不理想,脱落率为 15.4%至 63.3%。一种创新且有前途的干预措施,即虚拟现实(VR),可能会提高康复的依从性。本研究旨在评估在接受 CR 的 HF 患者中使用该技术进行 VR 的效果,以依从性(主要结局)、功能能力、感知用力、心绞痛、生活质量、心率、血氧饱和度、血压、最大摄氧量、分钟通气量/二氧化碳产生斜率、氧脉冲、NT-proBNP 血液值和 HF 相关再住院率(次要结局)为指标。

方法

将在意大利一家大型大学医院的心血管康复病房中进行一项 80 例患者的随机对照试验。参与者将被纳入研究,并随机(1:1)分配至实验组(接受高质量沉浸式 VR 联合 PICO 4®头显和 TREADMILL XR®软件的 CR,Arm 1)或对照组(标准 CR,Arm 2)。根据指南,患者将在一个月内每周两次,每次进行 30 分钟中等强度的 CR。

结果

预计干预组患者的主要和次要结局将显著改善。

结论

如果被证明有效,VR 可能是一种创新、安全且易于实施的数字健康干预措施,可提高 HF 患者对 CR 的依从性,并改善重要的临床结局。

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