Anti-Arrhythmic Effects of Exercise After an Implantable Defibrillator (ICD)

描述(申请人提供)：这项研究的长期目标是设计运动干预措施，以减少使用植入式心律失常除颤器(ICD)的室性心律失常患者的主要不良心脏事件(心脏病发病率和死亡率)和护理成本。本研究的目的是确定在常规护理的基础上进行有氧运动干预是否会显著改善心肺功能、心脏自主神经活动和生活质量，同时减少室性心律失常患者的室性心律失常、炎症和心理痛苦，这些患者患有ICD，可以二级预防心脏骤停(SCA)。众所周知，有氧运动可以增加副交感心血管调节，降低心脏死亡率。在我们的先导性研究中，我们证明了有氧训练可以安全地在这一人群中实施，有氧训练足以改善心肺功能。本研究的具体目的是验证以下假设：1)有氧运动(每周5小时，以60%-80%的V02峰值心率回家步行8周，然后进行16周的运动维持)与常规护理相比，将增加心肺功能(V02峰值)；2)有氧运动将增加心脏自主神经活动(心率变异性(HRV)和与健康相关的生活质量(SF-36和患者关注的问题)，同时减少室性心律失常(ICD休克、VF/VT)、心理困扰(焦虑和抑郁)和炎症(hsCRP、BNP、TNF-α、IL-6)；3)有氧运动通过改善心肺功能对转归产生影响。采用随机临床试验形式，除了常规护理外，还将测试有氧运动计划与单独常规护理的对比。运动干预的目的是在心肺运动测试后在家中进行，使用仔细的电话和极心率监测。治疗8周末心肺功能改善情况为疗效的主要分析指标。该计划的纵向效果将在6个月后进行评估。其次，描述有氧运动对其他结果的影响将被确定。研究结果有望在ICD后制定运动处方的临床上有用，并可推广到患有ICD的复发SCA高危人群。

DESCRIPTION (provided by applicant): The long term goal of this research is to design exercise interventions to reduce major adverse cardiac events (cardiac morbidity and mortality) and costs of care in individuals who have ventricular arrhythmias with an implantable cardioverter defibrillator (ICD). The goal of this study is to determine if an aerobic exercise intervention in addition to usual care, will significantly improve cardiopulmonary function, cardiac autonomic activity, and quality of life while reducing ventricular arrhythmias, inflammation, and psychological distress in patients with ventricular arrhythmias who have an ICD for the secondary prevention of sudden cardiac arrest (SCA). Aerobic exercise is known to increase parasympathetic cardiovascular regulation and reduce cardiac mortality. In our pilot study, we demonstrated that aerobic conditioning, strenuous enough to improve cardiopulmonary function, could be safely implemented in this population. The specific aims of this study are to test the hypotheses that: 1) aerobic exercise (5 hours/week for 8 weeks home walking at 60- 80% of peak V02 HR followed by 16 weeks of exercise maintenance) compared to usual care alone will increase cardiopulmonary function (peak V02), 2) aerobic exercise will increase cardiac autonomic activity (heart rate variability (HRV) and health related quality of life (SF-36 and Patient Concerns), while reducing ventricular arrhythmias (ICD shocks, VF/VT), psychological distress (anxiety and depression), and inflammation (hsCRP, BNP, TNF-alpha, IL-6); and 3) aerobic exercise will mediate effects on outcomes through improvement in cardiopulmonary function. Using a randomized clinical trial format, an aerobic exercise program in addition to usual care will be tested against usual care alone. The exercise intervention is designed to be conducted at home after a cardiopulmonary exercise test, using careful telephone and Polar Heart rate monitoring. The primary analysis for treatment effect is improvement in cardiopulmonary function at the end of 8 weeks. Longitudinal effects of the program will be assessed at 6 months. Secondarily, describing the effects of aerobic exercise on other outcomes will be determined. Study findings are expected to be useful clinically in making exercise prescriptions after an ICD and to be generalizable to populations at risk for recurrent SCA who have an ICD.