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

植入式除颤器 (ICD) 后运动的抗心律失常作用

• 批准号: 7257583
• 负责人: CYNTHIA M DOUGHERTY
• 金额: $ 72.23万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7257583
• 关键词: Aerobic; Aerobic Exercise; Affect; Age; Age Factors; Anti-Arrhythmia Agents; Anxiety; Arrhythmia; Autonomic nervous system; Belief; Cardiac; Cardiopulmonary; Cardiovascular Diseases; Cardiovascular system; Caring; Cessation of life; Clinical Trials Design; Defibrillators; Development; Distress; EFRAC; Event; Exercise; Exercise stress test; Future; Gender; Goals; Health; Health Personnel; Heart Arrest; Heart Diseases; Heart Rate; Home environment; Hour; Implant; Implantable Defibrillators; Individual; Inflammation; Interleukin-6; Intervention; K-Series Research Career Programs; Life; Maintenance; Mediating; Mental Depression; Modeling; Monitor; Morbidity - disease rate; Numbers; Outcome; Outcome Study; Parasympathetic Nervous System; Patients; Personal Satisfaction; Persons; Pilot Projects; Population; Populations at Risk; Predisposition; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Recurrence; Regulation; Research; Research Personnel; Resuscitation; Risk; Role; SF-36; Sampling; Secondary Prevention; Shock; Symptoms; Telephone; Testing; Theoretical model; Time; Training; Tumor Necrosis Factor-alpha; Ventricular; Ventricular Arrhythmia; Ventricular Fibrillation; Ventricular Tachycardia; Walking; Week; conditioning; cost; cysteine rich protein; design; health related quality of life; human TNF protein; improved; innovation; mortality; prescription document; prescription procedure; prevent; programs; psychological distress; psychosocial; treatment effect

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.

描述（由申请人提供）：本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转复除颤器 (ICD) 的室性心律失常患者的主要不良心脏事件（心脏发病率和死亡率）和护理费用。本研究的目的是确定除了常规护理之外，有氧运动干预是否会显着改善心肺功能、心脏自主活动和生活质量，同时减少患有室性心律失常的室性心律失常患者的室性心律失常、炎症和心理困扰。用于心脏骤停 (SCA) 二级预防的 ICD。众所周知，有氧运动可以增加副交感心血管调节并降低心脏死亡率。在我们的试点研究中，我们证明了足以改善心肺功能的有氧运动可以在这一人群中安全实施。本研究的具体目的是检验以下假设：1) 与单独常规护理相比，有氧运动（每周 5 小时，持续 8 周，以峰值 V02 HR 的 60-80% 在家步行，然后进行 16 周的运动维持）将增加心肺功能（峰值 V02），2）有氧运动将增加心脏自主活动（心率变异性 (HRV) 和健康相关的生活质量（SF-36 和患者）担忧），同时减少室性心律失常（ICD 电击、心室颤动 (VF/VT)）、心理困扰（焦虑和抑郁）和炎症（hsCRP、BNP、TNF-α、IL-6）；3) 有氧运动将调节对结果的影响；通过改善心肺功能。采用随机临床试验的形式，将常规护理之外的有氧运动计划与单独的常规护理进行比较。运动干预旨在在心肺运动测试后在家中进行，使用仔细的电话和 Polar 心率监测。治疗效果的主要分析是8周结束时心肺功能的改善。该计划的纵向影响将在 6 个月后进行评估。其次，将确定描述有氧运动对其他结果的影响。研究结果预计将在临床上用于 ICD 后制定运动处方，并可推广到装有 ICD 的有复发性 SCA 风险的人群。