Effects of VIRTUal reALity on Rehabilitation in Patients With Heart Failure: a Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- adherence to cardiac rehabilitation
研究概览
简要总结
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 undergoing CR 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 rehospitalization rates due to HF (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 will receive 30-minute CR sessions 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 years;
- •clinically stable chronic HF diagnosis with left ventricular ejection fraction (LVEF) < 40%
排除标准
- •conditions that exclude exercise training (e.g., bone fractures);
- •conditions that exclude VR use of VR (e.g., blindness and deafness
- •severe cognitive impairment, documented with a score of 0 - 4 on the Six-item Screener;
- •end-stage renal disease requiring dialysis;
- •ascertained advanced pneumopathies;
- •active neoplasms;
- •rheumatic diseases.
结局指标
主要结局
adherence to cardiac rehabilitation
时间窗: after 4 weeks
adherence to cardiac rehabilitation measured as the number of sessions performed, compared to the scheduled sessions expressed as a percentage
次要结局
- NT-probnp(at baseline and after 8 weeks)
- Quality of life of patients with heart failure(at baseline, after 4 and 8 weeks)
- Functional capacity(at baseline, after 4 and 8 weeks)
- Angina(at baseline, after 4 and 8 weeks)
- blood pressure(at baseline, after 4 and 8 weeks)
- Maximal oxygen uptake(at baseline and after 8 weeks)
- HF-related rehospitalization(after 8 weeks from the stard of the study)
- Perceived exertion(at baseline, after 4 and 8 weeks)
- heart rate(at baseline, after 4 and 8 weeks)
- oxygen saturation(at baseline, after 4 and 8 weeks)
- Minute ventilation/carbon dioxide production slope(at baseline and after 8 weeks)
- oxygen pulse(at baseline and after 8 weeks)
研究者
Valentina Micheluzzi
MSN, RN
Azienda Ospedaliero Universitaria di Sassari