Effects of Virtual Reality-Based Cardiac Rehabilitation in Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Cardiac Rehabilitation Adherence
研究概览
简要总结
This randomized controlled study will evaluate whether adding immersive virtual reality (VR) to cardiac rehabilitation can improve participation in rehabilitation and other health outcomes in patients who have recently undergone cardiac surgery.
Cardiac rehabilitation is recommended after cardiac surgery to support recovery, improve physical function and quality of life, and reduce complications related to physical inactivity. However, some patients have difficulty completing the recommended rehabilitation program. Immersive VR may make exercise sessions more engaging and may help patients participate more consistently in their rehabilitation.
The study will enroll 46 adult patients who have undergone cardiac surgery within the previous 30 days, are clinically stable, and have an indication for cardiac rehabilitation. Participants will be randomly assigned in a 1:1 ratio to either an immersive VR group or a standard cardiac rehabilitation group.
Participants in both groups will complete the same supervised cardiac rehabilitation program, consisting of eight moderate-intensity exercise sessions performed on a treadmill or stationary bicycle. Each session will last approximately 30 minutes and will be performed twice a week for four weeks.
Participants assigned to the VR group will perform their rehabilitation sessions while wearing an immersive VR headset. The headset will provide natural audiovisual environments designed to create an immersive experience during exercise. A trained healthcare professional will assist participants with the technology and supervise them throughout each session. Participants will be able to stop the VR experience at any time if needed. Participants assigned to the control group will complete the same rehabilitation program without VR.
The primary outcome of the study is adherence to cardiac rehabilitation, measured as the percentage of scheduled rehabilitation sessions completed.
Secondary outcomes will assess changes from baseline to the end of the rehabilitation program in functional capacity using the 6-minute walk test, perceived exertion using the Borg scale, angina severity, cardiopulmonary exercise test parameters, heart rate, blood pressure, oxygen saturation, and health-related quality of life using the Kansas City Cardiomyopathy Questionnaire.
In the VR group, symptoms potentially related to VR exposure, known as cybersickness, will be assessed after each session using the Virtual Reality Symptom Questionnaire. At the end of the program, participants in the VR group will also be invited to take part in a semi-structured interview about their experience with virtual reality.
The study aims to determine whether immersive VR can be a useful approach to support participation in cardiac rehabilitation after cardiac surgery while also evaluating its effects on physical, clinical, and patient-reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 years;
- •a clinically stable cardiovascular diagnosis.
排除标准
- •conditions precluding physical exercise (e.g., bone fractures);
- •conditions precluding the use of virtual reality (e.g., blindness and deafness);
- •severe cognitive impairment, documented by a score of 0 to 4 on the Six-Item Screener;
- •end-stage renal disease requiring dialysis;
- •established advanced pulmonary disease;
- •active malignancies;
- •rheumatic diseases.
结局指标
主要结局
Cardiac Rehabilitation Adherence
时间窗: At completion of the 4-week cardiac rehabilitation program (after the eighth session)
Cardiac rehabilitation adherence will be measured as the percentage of scheduled rehabilitation sessions completed by each participant. Adherence will be calculated as the number of completed sessions divided by the total number of eight scheduled sessions, multiplied by 100. Higher percentages indicate greater adherence.
次要结局
- Change from Baseline in Six-Minute Walk Test Distance at 4 Weeks(Baseline and 4 weeks (after the eighth rehabilitation session))
- Change from Baseline in Rating of Perceived Exertion at 4 Weeks(Baseline and 4 weeks (after the eighth rehabilitation session).)
- Change from Baseline in Canadian Cardiovascular Society Angina Class at 4 Weeks(Baseline and 4 weeks (after the eighth rehabilitation session))
- Change from Baseline in Metabolic Equivalents During Cardiopulmonary Exercise Testing at 4 Weeks(Baseline and 4 weeks (after the eighth rehabilitation session).)
- Change from Baseline in Exercise Workload Capacity During Cardiopulmonary Exercise Testing at 4 Weeks(Baseline and 4 weeks (after the eighth rehabilitation session).)
- Occurrence of Exercise-Induced Arrhythmias During Cardiopulmonary Exercise Testing(Baseline and 4 weeks (after the eighth rehabilitation session).)
- Change from Baseline in Heart Rate at 4 Weeks(Baseline and 4 weeks (after the eighth rehabilitation session).)
- Change from Baseline in Peripheral Oxygen Saturation at 4 Weeks(Baseline and 4 weeks (after the eighth rehabilitation session).)
- Change from Baseline in Systolic Blood Pressure at 4 Weeks(Baseline and 4 weeks (after the eighth rehabilitation session).)
- Change from Baseline in Diastolic Blood Pressure at 4 Weeks(Change from Baseline in Diastolic Blood Pressure at 4 Weeks)
- Change from Baseline in Kansas City Cardiomyopathy Questionnaire Score at 4 Weeks(Baseline and 4 weeks (after the eighth rehabilitation session).)
- Virtual Reality-Related Cybersickness(Immediately after each of the eight virtual reality sessions, over 4 weeks.)
研究者
Valentina Micheluzzi
Principal Investigator
Azienda Ospedaliero Universitaria di Sassari