Primary Care Research Unit of Bizkaia, Basque Health Service-Osakidetza, CAIBER, Bilbao, Spain.
BMC Public Health. 2010 Jan 25;10:33. doi: 10.1186/1471-2458-10-33.
Quality of life (QoL) decreases as heart failure worsens, which is one of the greatest worries of these patients. Physical exercise has been shown to be safe for people with heart failure. Previous studies have tested heterogeneous exercise programs using different QoL instruments and reported inconsistent effects on QoL. The aim of this study is to evaluate the effectiveness of a new exercise program for people with heart failure (EFICAR), additional to the recommended optimal treatment in primary care, to improve QoL, functional capacity and control of cardiovascular risk factors.
METHODS/DESIGN: Multicenter clinical trial in which 600 patients with heart failure in NYHA class II-IV will be randomized to two parallel groups: EFICAR and control. After being recruited, through the reference cardiology services, in six health centres from the Spanish Primary Care Prevention and Health Promotion Research Network (redIAPP), patients are followed for 1 year after the beginning of the intervention. Both groups receive the optimized treatment according to the European Society of Cardiology guidelines. In addition, the EFICAR group performs a 3 month supervised progressive exercise program with an aerobic (high-intensity intervals) and a strength component; and the programme continues linked with community resources for 9 months. The main outcome measure is the change in health-related QoL measured by the SF-36 and the Minnesota Living with Heart Failure Questionnaires at baseline, 3, 6 and 12 months. Secondary outcomes considered are changes in functional capacity measured by the 6-Minute Walking Test, cardiac structure (B-type natriuretic peptides), muscle strength and body composition. Both groups will be compared on an intention to treat basis, using multi-level longitudinal mixed models. Sex, age, social class, co-morbidity and cardiovascular risk factors will be considered as potential confounding and predictor variables.
A key challenges of this study is to guarantee the safety of the patients; however, the current scientific evidence supports the notion of there being no increase in the risk of decompensation, cardiac events, hospitalizations and deaths associated with exercise, but rather the opposite. Safety assurance will be based on an optimized standardised pharmacological therapy and health education for all the participants.
Clinical Trials.gov Identifier: NCT01033591.
随着心力衰竭的恶化，生活质量（QoL）下降，这是这些患者最担心的问题之一。运动已被证明对心力衰竭患者是安全的。先前的研究使用不同的 QoL 工具测试了异质运动方案，并报告了对 QoL 的不一致影响。本研究旨在评估一种新的心力衰竭患者运动方案（EFICAR）的有效性，该方案除了在初级保健中推荐的最佳治疗外，还可以提高生活质量、功能能力和控制心血管危险因素。
方法/设计：这是一项多中心临床试验，将 600 名纽约心脏协会（NYHA）II-IV 级心力衰竭患者随机分为两组：EFICAR 组和对照组。通过参考心脏病学服务，在西班牙初级保健预防和健康促进研究网络（redIAPP）的六个卫生中心招募患者后，在干预开始后 1 年内对患者进行随访。两组均根据欧洲心脏病学会指南接受最佳治疗。此外，EFICAR 组进行为期 3 个月的监督性渐进运动计划，包括有氧运动（高强度间歇训练）和力量训练；并在 9 个月内继续与社区资源联系。主要结局测量指标是 SF-36 和明尼苏达州心力衰竭生活质量问卷在基线、3、6 和 12 个月时健康相关生活质量的变化。考虑的次要结局是 6 分钟步行试验测量的功能能力变化、心脏结构（B 型利钠肽）、肌肉力量和身体成分的变化。将使用多层次纵向混合模型对两组进行意向治疗比较。性别、年龄、社会阶层、合并症和心血管危险因素将被视为潜在的混杂和预测变量。
这项研究的一个关键挑战是保证患者的安全；然而，目前的科学证据支持运动不会增加失代偿、心脏事件、住院和死亡的风险，而是相反的观点。安全性保证将基于所有参与者的优化标准化药物治疗和健康教育。
ClinicalTrials.gov 标识符：NCT01033591。
