ACTION EQOL STUDY

行动情商研究

• 批准号: 6424993
• 负责人: Kevin Alan Schulman
• 金额: $ 48.33万
• 依托单位: DUKE 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/6424993
• 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和 纽约心脏协会 II-IV 级运动训练的有效性 充血性心力衰竭患者除了标准护理与 仅标准护理策略。次要目标是确定 运动相关并发症的发生率和意义、对运动的影响 运动耐力和生活质量，以及成本效益 训练。 演习训练将包括36场设施训练 接下来是家庭锻炼和间歇设施训练。培训将 保持在心率储备的 60-70%。患者随机分配到训练组 将通过步行或自行车测力计进行训练。跑步机或锻炼 协调中心将向培训患者提供自行车，如果 想要的。有效性将被定义为主要综合终点 全因死亡率和全因住院率。 对照组的预期年基线率为 30%。预期的 第一年不遵守和辍学率为 35%，每年为 15% 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策略来改善 训练臂中患者的依从性。使用这些假设，总共 需要 3000 名受试者的样本量才能检测到 20% 的减少 主要结局的 alpha 水平为 0.05，功效大于 80%。如果 第一年不依从率和辍学率下降至 30% 此后每年 12.5%，检测 20% 差异的能力更大 超过90%。主要分析将基于意向治疗。 试验将持续 5 年以上，最初有 6 个月的时间进行规划， 培训和实施；入学3年； 1年随访；和 6 个月的时间用于收尾、分析和演示。