Effects of Virtual Physiotherapy on Exercise Training in Cardiac Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in exercise capacity
研究概览
简要总结
The investigators hypothesize that exercise training program guided by virtual augmented reality glasses or by video from computer screen used at home will improve motivation into exercise training and results in superior adherence to exercise training compared to current practice. The primary objectives of this research project are to study the effects of exercise training guidance by novel technology on 1) exercise capacity, 2) adherence to exercise training, 3) changes in cardiac autonomic function and 4) quality of life in acute coronary syndrome (ACS) patients.
详细描述
The subjects of the study will be recruited from the consecutive series of patients of men and women admitted to Oulu University Hospital due to an acute coronary syndrome (ACS). The study population will be randomized into control group (n=25) and study group (n=25) matched with age and gender. For all subjects, clinical status including quality of life questionnaire, exercise capacity and autonomic function measurements will be performed at baseline and after exercise training. Exercise training program is six months for both groups according to current guidelines. All the patients will have a detailed and personalized training prescription. Study group will have virtual augmented reality glasses or computer with training video to motivate and control exercise training prescription at home.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent (< 1 month) acute coronary syndrome
排除标准
- •New York Heart Association (NYHA) functional classification class IV (heart failure)
- •unstable chest pain (angina pectoris, Canadian Cardiovascular Society grading of angina pectoris class 4)
- •ST-segment elevation myocardial infarction (STEMI)
- •implanted cardioverter defibrillation or pacemaker (or planned)
- •chronic atrial fibrillation
- •musculoskeletal disorder (unable to participate exercise training)
- •participation in competing clinical trial
- •severe peripheral atherosclerosis
- •retinopathy or neuropathy
- •life-expectancy due to other serious disease < 2 years or any other reason why patient is unable or unwilling to provide written informed consent.
研究组 & 干预措施
Current guidelines rehabilitation
Exercise rehabilitation at home according to current guidelines. Training is guided and controlled by diary.
干预措施: Current guidelines rehabilitation (Behavioral)
Mobile device guided rehabilitation
Exercise rehabilitation at home according to current guidelines. Training is guided and controlled by virtual augmented reality glasses or by mobile device.
干预措施: Mobile device guided rehabilitation (Behavioral)
结局指标
主要结局
Change in exercise capacity
时间窗: Six months (baseline and 6 months)
Change in maximal load during exercise stress test (metabolic equivalents)
次要结局
- Adherence to exercise rehabilitation(Weekly from baseline to six months)
- Change in the standard deviation of normal to normal intervals (SDNN) of heart rate variability(Six months (baseline and 6 months))
- Change in very low frequency (VLF) of heart rate variability(Six months (baseline and 6 months))
- Change in low frequency (LF) of heart rate variability(Six months (baseline and 6 months))
- Change in high frequency (HF) of heart rate variability(Six months (baseline and 6 months))
- Change in fractal scaling exponent of heart rate variability(Six months (baseline and 6 months))
- Change in baroreflex sensitivity(Six months (baseline and 6 months))
- Change in quality of life(Six months (baseline and 6 months))