Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Fitness
研究概览
简要总结
Regular exercise in patients who have heart disease is highly beneficial and improves quality of life and survival. Exercise training is considered a core component of cardiac rehabilitation (CR), which is a multicomponent program delivered to patients who have heart disease. However, it is severely underutilized because people simply don't have the time or the resources to travel to a CR centre to attend rehab appointments.
The investigators have developed a novel virtual reality (VR) based CR exercise system (MedBike). This system consists of an exercise bike attached to a VR world; it makes exercise engaging and fun. Furthermore, patients can be monitored during exercise remotely over the internet. The investigators intend to perform a pilot randomized controlled trial in which 10 patients are assigned to the MedBike system and 10 to standard CR. The investigators think that the MedBike system will increase exercise program compliance by providing an enjoyable and engaging exercise experience which can be performed in the comfort of one's own home. The investigators think that this will improve fitness (primary endpoint) in these patients. If the investigators demonstrate that home based exercise is feasible, the investigators plan a larger study to prove that it is something that should be broadly implemented in patients with heart disease.
详细描述
Background Regular exercise, incorporated as part of a comprehensive cardiac rehabilitation (CR) program, improves morbidity and mortality in cardiac patients, especially those with elevated risk profiles. It was reported in a review that exercise decreased all-cause mortality, cardiac mortality, and non-fatal myocardial infarction by 20 to 25%. Of critical importance, CR non-participants exhibit a 30% lower survival rate than those who participate.
Even though exercise training is considered a core component of cardiac rehabilitation it is severely underutilized. The majority of adult patients do not participate in exercise rehabilitation following cardiac events or cardiac surgery; of those eligible, the completion rates are 15% to 30%. Factors associated with poor compliance include greater distance from the hospital, need for transportation (e.g. and parking fees), lack of self motivation, poor social support, low self-esteem, fear of safety and lack of enjoyment. In order to overcome these barriers, researchers and clinicians have been turning toward eHealth solutions to decentralize the CR process, increase accessibility, and potentially increase the comfort and enjoyment derived from exercise. This approach aligns closely with the American Heart Association's recommendation that Internet-based techniques be used to improve the CR experience for both patients and healthcare providers.
The Advanced Man Machine Interface Laboratory (AMMI), University of Alberta has developed a novel virtual reality (VR) enhanced exercise system (MedBIKE) which provides an engaging and enjoyable exercise experience while allowing CR patients to exercise in the comfort of their own home. The system consists of a mountain bike mounted on a wirelessly controlled resistance machine fed directly into a VR console.
This VR console allows for a heightened exercise experience for the patient by allowing them to cycle through a virtual landscape. While exercising, the patients are monitored remotely in real-time by a CR clinician using wireless biometric sensors (electrocardiogram, blood pressure, and pulse oximetry) and a bidirectional audio-video Internet connection. The investigators believe that by enhancing the exercise experience, eliminating distance and transportation issues, and providing ongoing support from key healthcare providers, patient compliance with the CR exercise program will improve. The MedBIKE has not been tested in a clinical trial.
Objective and Hypothesis:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of stable ischemic heart disease
- •received a recent uncomplicated coronary angioplasty or coronary artery bypass graft
- •participants will be required to have a referral for cardiac rehabilitation.
排除标准
- •a history of heart failure
- •a history of cardiac arrhythmia requiring cardioversion
- •an implantable cardiac defibrillator
- •unable to cycle on a bike
研究组 & 干预措施
Control: Standard therapy
Participants in this arm of the study will receive standard therapy.
MedBIKE
Participants in this arm will be using the new MedBIKE system as their method of rehabilitation.
干预措施: MedBIKE (Behavioral)
结局指标
主要结局
Fitness
时间窗: 8 weeks
Change in fitness measured at 8 weeks using Bruce protocol treadmill test performance time as a metric.
Compliance
时间窗: 8 weeks
The investigators will be counting the number of sessions performed in both study arms in their 8 weeks of rehab to determine if there is a difference. This will include scheduled and unscheduled sessions through session documentation and patient self-reporting.
次要结局
- Change in resting blood pressure(8 weeks)
- Change in A1c(8 weeks)
- Smoking status(8 weeks)
- Cholesterol (LDL, HDL, Triglycerides)(8 weeks)
研究者
Peter Wood
Research Associate
University of Alberta