HEART FAILURE AND A CONTROLLED TRIAL INVESTIGATING OUTCOMES OF EXER TRAINING

心力衰竭和研究运动训练结果的对照试验

• 批准号: 7608099
• 负责人: Udho Thadani
• 金额: $ 0.12万
• 依托单位: UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608099
• 关键词: Address; Canada; Caring; Class; Clinic; Clinical; Community Health Centers; Computer Retrieval of Information on Scientific Projects Database; Consent; Death Rate; EFRAC; Economics; End Point; Exercise; Exercise stress test; Functional disorder; Funding; Gases; Grant; Health; Heart; Heart failure; Home environment; Hospitalization; Institution; International; Intervention; Left; Mental Depression; New York; Outcome; Patients; Quality of life; Randomized; Randomized Controlled Clinical Trials; Recruitment Activity; Registries; Research; Research Personnel; Resources; Source; Specific qualifier value; Standards of Weights and Measures; Symptoms; Telephone; Time; Training; Treatment Protocols; United States National Institutes of Health; Upper arm; Ventricular; follow-up

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Heart Failure and A Controlled Trial Investigating Outcomes of exercise traiNing (HF-ACTION) is a multicenter, international, randomized trial that addresses the primary hypothesis that patients with left ventricular (LV) systolic dysfunction and New York Heart Association (NYHA) class II_IV symptoms who are given exercise training in addition to standard care will have a greater than or equal to 20% lower rate of death and hospitalization over two years than patients who receive usual care alone. Important secondary endpoints include exercise testing parameters, economics, quality of life, and depression. Over three years, regional centers in the US and Canada and their satellite centers will recruit 3,000 consenting patients with heart failure (JF), LC ejection fraction (EF) less than or equal to 35%, and NYHA class II-IV. Once identified and screened, these patients will be randomized in a 1:1 fashion to receive usual care or usual care plus exercise training. Patients in the intervention arm will undergo 36 supervised exercise training sessions before initiating a home exercise training regimen that will be supplemented with occasional supervised review training sessions. All patients will perform gas exchange exercise tests at baseline, 3 months, 12 months, and 24 months of follow up. All randomized patients will receive follow up clinic and telephone calls a pre-specified times. Registries of clinical information will be maintained on eligible patients who decline trial entry. The results of the HP-ACTION trial will have a significant impact on the health and quality of life of millions of patients who now suffer from HF.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 心力衰竭和对锻炼训练结果（HF-ACTION）的对照试验调查是一项多中心，国际，随机试验，它解决了以下主要假设，即患有左心室（LV）收缩功能障碍（NYHA）II_IV级的纽约心脏功能障碍（NYHA）的患者受到同等或相等的治疗率更高，并且在治疗20％的情况下，纽约II_ IIV症状的患者受到了更大的锻炼。 重要的次要终点包括运动测试参数，经济学，生活质量和抑郁症。在三年的时间里，美国和加拿大及其卫星中心将招募3,000名同意患有心力衰竭的患者（JF），LC射血分数（EF）小于或等于35％，以及NYHA II-IV。 一旦确定和筛选，这些患者将以1：1的方式随机分配，以接受通常的护理或通常的护理以及运动训练。 干预部门的患者将在启动家庭锻炼培训方案之前进行36次监督运动培训课程，该方案将接受偶尔有监督的审查培训课程。 所有患者将在基线，3个月，12个月和24个月的随访时进行气体交换运动测试。 所有随机患者都将在预先指定的时间接受后续诊所和电话。 临床信息的注册将对拒绝进入试验的合格患者进行维护。 HP-Action试验的结果将对数百万现在患有HF的患者的健康和生活质量产生重大影响。