Exercise Training in Patients With Atrial Fibrillation (OPPORTUNITY Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Change in exercise capacity as measured by six-minute walk test distance
研究概览
简要总结
Atrial fibrillation is the most common heart rhythm disorder. The management of atrial fibrillation is of great importance. Despite the presence of exercise intolerance, weight gain, and an associated decline in overall health and well-being in patients living with atrial fibrillation, recommended standard care does not currently include the prescription of exercise to address these significant health issues. Exercise training is a recognized form of treatment of persons with heart disease. An exercise program such as high-intensity interval training when compared to moderate-intensity continuous exercise training may provide a stronger training stimulus for exercise and clinical outcomes; may be more efficient and motivating; and, may help to improve adherence to exercise training in persistent or permanent atrial fibrillation patients. This has been shown in patients with coronary artery disease and heart failure.
The primary objectives of this prospective study are to examine the impact of high-intensity interval training compared to moderate-intensity continuous exercise training in adults with persistent or permanent atrial fibrillation on exercise capacity and quality of life.
详细描述
Atrial fibrillation is the most common heart rhythm disorder. Significant disease and death rates are associated with atrial fibrillation because of stroke risk, the complications of medications, poor quality of life and reduced exercise tolerance. Many patients report they have a lower quality of life because of this condition, so finding new ways of helping patients manage and cope with this health problem may help a great number of people. The management of atrial fibrillation is of great importance. Despite the presence of exercise intolerance, weight gain, and an associated decline in overall health and well-being in patients living with atrial fibrillation, recommended standard care does not currently include the prescription of exercise to address these significant health issues. Exercise training is a recognized form of treatment of persons with heart disease. An exercise program such as high-intensity interval training when compared to moderate-intensity continuous exercise training may provide a stronger training stimulus for exercise and clinical outcomes; may be more efficient and motivating; and, may help to improve adherence to exercise training in persistent or permanent atrial fibrillation patients. This has been shown in patients with coronary artery disease and heart failure.
The primary objectives of this prospective study are to examine the impact of high-intensity interval training compared to moderate-intensity continuous exercise training in adults with persistent or permanent atrial fibrillation on exercise capacity and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •persistent or permanent atrial fibrillation;
- •rate controlled with a resting ventricular rate of equal to or less than 110 bpm;
- •able to perform a symptom-limited exercise test;
- •at least 40 years of age;
- •patient agrees to sign informed consent.
排除标准
- •currently participating in routine exercise training (more than two times per week);
- •unstable angina;
- •uncontrolled diabetes mellitus;
- •diagnosed severe mitral or aortic stenosis;
- •diagnosed hypertrophic obstructive cardiomyopathy with significant obstruction;
- •unable to provide written, informed consent.
结局指标
主要结局
Change in exercise capacity as measured by six-minute walk test distance
时间窗: baseline to 12 weeks
Change in exercise capacity from baseline to 12 weeks as measured by six-minute walk test distance.
Change in quality of life as measured by the Short-Form 36 questionnaire
时间窗: baseline to 12 weeks
Change in quality of life from baseline to 12 weeks as measured by the Short Form-36 questionnaire.
次要结局
- Change in symptom burden measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale(baseline to 12 weeks)
- Insomnia severity index will be measured using the Insomnia Severity Index(baseline to 12 weeks)
- Change in self reported sleep patterns will be measured using a 7-day sleep diary(baseline to 12 weeks)
- Change in heart rate control will be measured using 24-hour Holter ECG recordings and ECG recordings at each cardiopulmonary exercise test (CPET)(baseline to 12 weeks)
- Change in muscular fitness will be measured using standard load tests(baseline to 12 weeks)
- Change in exercise capacity will be measured using a cardiopulmonary exercise test (CPET)(baseline to 12 weeks)
- Change in exercise adherence measured by accelerometer(baseline to 12 weeks)
- Change in activity status measured by the Duke Activity Status Index(baseline to 12 weeks)
- Change in disease specific quality of life will be measured using the University of Toronto Atrial Fibrillation Severity Scale (AFSS)(baseline to 12 weeks)
- Change in symptom frequency and severity measured using the 7-day symptom diary(baseline to 12 weeks)
- Change in anxiety and depressive symptoms will be measured using the Hospital Anxiety and Depression Scale (HADS)(baseline to 12 weeks)
- Change in sleep apnea risk will be measured by the STOP-BANG Sleep Apnea Questionnaire(baseline to 12 weeks)