Improving cardiac rehabilitation outcomes with evidence-based obesity treatment.

项目摘要 冠心病(CHD)造成了巨大的身体、社会和经济负担，而这种负担 估计有620万且迅速增长的冠心病患者肥胖，可能会加剧这种情况。 心脏康复计划有可能显著降低冠心病的发病率和死亡率 病人。然而，以运动为基础的心脏康复对提高运动能力和 冠心病合并肥胖患者的冠心病危险因素被钝化。因此，这些患者中有很大一部分不是 在目前的护理标准下，体验最佳治疗将带来好处。心脏康复计划是 目前受持续时间较短(3个月)的限制，对肥胖治疗的关注不足(营养与热量 摄入量)，无法产生有意义的体重减轻(&lt；3%)。虽然有多条证据表明 减少热量摄入以减轻体重和脂肪等策略将改善冠心病患者的预后 对于肥胖，一项权威的随机临床试验使用循证方法在 需要心脏康复设置。这项研究的主要目标是检验主要假设 增加了一种新的为期6个月的行为减肥干预措施(即，限制卡路里的饮食和膳食替代) 以运动为基础的心脏康复将使运动能力、动脉功能、 身体成分和脂肪分布、生活质量、冠心病危险因素和炎症。我们还将检查 通过在干预12个月后重新评估结果来确定短期效益是否长期持续 完成并探索在3.5年随访期内对心血管事件和死亡率的影响。至 为了实现这一目标，我们将随机选择120名肥胖成年人(体重指数≥为30公斤/平方米或腰围为102厘米 男性和女性88厘米)，年龄55-75岁，患有冠心病，至单独接受心脏康复(Rehab)6个月或 到心脏康复加行为减肥干预(Rehab+WL)，导致身体脂肪减少。这个 具体目的是确定康复+WL与单独康复对运动能力的影响，通过 步行6分钟(主要目标)；动脉波反射指数(主动脉增大指数、反射 幅度、收缩晚期负荷)、动脉僵硬(颈动脉-股动脉脉搏波速度)、峰值有氧能力 (VO2峰值)、生活质量(SF-36)、身体成分(DXA)、体脂分布(CT)、冠心病危险因素 (血脂、血糖、血压)和炎症(次要目标)；以及包括所有- 在长达3.5年的随访中导致死亡和心血管事件(探索性目标)。确定 旨在促进有意义的减肥和持续的行为改变的新干预措施 可改善冠心病肥胖症患者的预后和远期预后有明显潜力 推进这一领域，并为以肥胖为重点的医疗保健政策变化提供更多支持。确认 我们的假设将为在心脏康复中增加正式的减肥计划提供强大的推动力 指导和实施冠心病肥胖患者的护理新模式。

Project Summary Coronary heart disease (CHD) presents an enormous physical, social and economic burden, and this burden may be exacerbated in the estimated 6.2 million and rapidly growing number of CHD patients who are obese. Cardiac rehabilitation programs have the potential to significantly reduce morbidity and mortality in CHD patients. However, the efficacy of exercise-based cardiac rehabilitation for improving exercise capacity and CHD risk factors is blunted in CHD patients with obesity. As such, a large proportion of these patients are not experiencing optimal treatment benefits with the current standard of care. Cardiac rehabilitation programs are currently limited by their short duration (3 months), inadequate focus on obesity treatment (nutrient vs. caloric intake), and inability to produce meaningful weight loss (<3%). While multiple lines of evidence suggest that a strategy such as caloric restriction that produces weight and fat loss will improve outcomes in CHD patients with obesity, a definitive randomized clinical trial using evidence-based approaches to weight loss in the cardiac rehabilitation setting is needed. The primary goal of this study is to test the main hypothesis that adding a novel 6-month behavioral weight loss intervention (i.e., calorie-restricted diet with meal replacements) to exercise-based cardiac rehabilitation will lead to greater improvements in exercise capacity, arterial function, body composition and fat distribution, quality of life, CHD risk factors, and inflammation. We will also examine whether short-term benefits are sustained long-term by reassessing outcomes 12 months after intervention completion and exploring effects on cardiovascular events and mortality during a 3.5 year follow-up period. To accomplish this goal, we will randomize 120 obese adults (BMI ≥30 kg/m2 or waist circumference >102 cm in men and >88 cm in women) aged 55-75 years with CHD to 6 months of cardiac rehabilitation (Rehab) alone or to cardiac rehabilitation plus a behavioral weight loss intervention (Rehab+WL) that elicits body fat loss. The specific aims are to determine the effects of Rehab+WL vs. Rehab alone on exercise capacity as measured by the 6-minute walk (primary aim); indices of arterial wave reflection (aortic augmentation index, reflection magnitude, late systolic load), arterial stiffness (carotid-femoral pulse wave velocity), peak aerobic capacity (VO2 peak), quality of life (SF-36), body composition (by DXA), body fat distribution (by CT), CHD risk factors (lipids, glucose, blood pressure), and inflammation (secondary aims); and a composite endpoint including all- cause mortality and cardiovascular events during up to 3.5 years of follow up (exploratory aim). Determining whether novel interventions designed to promote meaningful weight loss and sustained behavioral changes can improve outcomes and long-term prognosis in CHD patients with obesity has the potential to significantly advance the field and lend additional support for health care policy changes focused on obesity. Confirmation of our hypothesis will provide strong impetus for adding a formal weight loss program to cardiac rehabilitation guidelines and implementing new models of care for CHD patients with obesity.