ACTION - A CHF Trial Investigating Outcomes of Exercise

行动 - 调查运动结果的 CHF 试验

• 批准号: 6800021
• 负责人: RAY E. HERSHBERGER
• 金额: $ 15.29万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2007-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6800021
• 关键词: ACE inhibitors; beta antiadrenergic agent; cardiovascular disorder chemotherapy; cardiovascular disorder epidemiology; cardiovascular disorder therapy; clinical research; clinical trials; combination therapy; congestive heart failure; cooperative study; cost effectiveness; digoxin; exercise; hospital utilization; human mortality; human subject; human therapy evaluation; longitudinal human study; medical complication; outcomes research; patient oriented research; quality of life

DESCRIPTION (provided by applicant): The primary aim of the ACTION Trial is to determine the long-term safety and effectiveness of exercise training for New York Heart Association Classes II-IV congestive heart failure patients in addition to standard of care versus a strategy of standard care alone. The secondary objective is to determine the incidence and significance of exercise-related complications, the effect on exercise tolerance and quality of life, and the cost-effectiveness of training. The exercise training will include 36 facility-based training sessions followed by home-based exercise and interval facility sessions. Training will be at 60-70% of heart rate reserve. Patients randomized to the training arm will train by either walking or bicycle ergometers. Treadmills or exercise bicycles will be provided to training patients by the coordinating center, if desired. Effectiveness will be defined as the primary combined endpoint of all-cause mortality and all-cause hospitalizations. The expected annual baseline rate is 30% for the control group. The expected non-adherence and drop-out rate is 35% the first year and 15% annually thereafter, with a cross-over rate of 5% per year. The regional center team and the coordinating center will implement multiple strategies to improve adherence in patients in the training arm. Using these assumptions, a total sample size of 3000 subjects will be required to detect a 20% reduction in the primary outcome with an alpha level of 0.05 and a power greater than 80%. If the non-adherence and drop-out rate decrease to 30% in the first year and 12.5% annually thereafter, the power to detect a 20% difference is greater than 90%. The primary analysis will be based on intent-to-treat. The trial will take place over 5 years with an initial 6 months for planning, training, and implementation; 3 years of enrollment; 1 year of follow-up; and 6 months for close out, analysis, and presentation.

描述(由申请人提供)： 行动试验的主要目的是确定长期安全性和 纽约心脏协会II-IV级运动训练的效果 充血性心力衰竭患者除标准护理外，与 单独进行标准护理的策略。次要目标是确定 运动相关并发症的发生率和意义、对患者的影响 运动耐量和生活质量，以及 训练。 演习训练将包括36次基于设施的训练课程 然后是基于家庭的锻炼和间歇设施会议。培训将会 保持心率储备的60%-70%。患者被随机分配到训练组 将通过步行或自行车测功器进行训练。跑步机或锻炼 如果出现以下情况，协调中心将为培训患者提供自行车 想要。有效性将定义为以下各项的主要组合终点 全因死亡率和全因住院。 对照组的预期年基线率为30%。预期中的 第一年不遵守和辍学率为35%，每年为15% 此后，以每年5%的交叉率。区域中锋队 协调中心将实施多项战略，以改善 患者坚持在训练臂上。使用这些假设，总共 3000名受试者的样本容量将被要求检测到20%的减少 阿尔法水平为0.05且功率大于80%的主要结果。如果 不遵守和辍学率在第一年下降到30%， 每年12.5%之后，检测20%的差异的能力更大 而不是90%。初步分析将基于治疗意图。 试验将在5年内进行，最初的规划时间为6个月， 培训和实施；3年入学；1年后续行动；以及 6个月的收尾、分析和演示时间。