ACTION - A CHF Trial Investigating Outcomes of Exercise

行动 - 调查运动结果的 CHF 试验

• 批准号: 6668514
• 负责人: RAY E. HERSHBERGER
• 金额: $ 30.33万
• 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 2006-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6668514
• 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）： ACTION试验的主要目的是确定长期安全性， 运动训练对纽约心脏协会II-IV级患者的有效性 充血性心力衰竭患者除了标准治疗外， 标准护理策略。第二个目标是确定 运动相关并发症的发生率和意义， 运动耐量和生活质量，以及 训练 演习培训将包括36个设施培训课程 随后是家庭锻炼和间歇设施课程。培训将 保持60-70%的心率储备。患者随机分配至训练组 将通过步行或自行车测力计进行训练。跑步机或锻炼 协调中心将为培训患者提供自行车，如果 需要的话有效性将定义为以下主要联合终点： 全因死亡和全因住院。 对照组的预期年基线率为30%。预期 不遵守和辍学率是35%，第一年和15%，每年 此后，每年的交叉率为5%。区域中心团队 协调中心将实施多项战略， 使用这些假设， 需要3000例受试者的样本量才能检测到 主要结局，α水平为0.05，把握度大于80%。如果 第一年的不遵守率和辍学率降至30%， 此后每年12.5%，检测20%差异的把握度更大 超过90%。主要分析将基于意向治疗。 试验将持续5年，最初6个月用于规划， 培训和实施; 3年入组; 1年随访;以及 6个月的收尾、分析和演示。