Improving cardiac rehabilitation outcomes with evidence-based obesity treatment.

通过循证肥胖治疗改善心脏康复结果。

• 批准号: 9544372
• 负责人: Tina E Brinkley
• 金额: $ 73.22万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-08 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9544372
• 关键词: Address; Adult; Adverse effects; Aerobic; Affect; Behavioral; Blood Pressure; Body Composition; Body Weight; Body Weight decreased; Body fat; Caloric Restriction; Cardiac; Cardiac rehabilitation; Cardiovascular system; Caring; Clinical; Coronary heart disease; Data; Dual-Energy X-Ray Absorptiometry; Economic Burden; Energy Intake; Ensure; Event; Exercise; Fatty acid glycerol esters; Glucose; Goals; Guidelines; Health Policy; Health Status; Heart failure; Hospital Mortality; Inflammation; Intake; Intervention; Investigation; Lead; Lipids; Long-Term Effects; Maintenance; Measures; Modeling; Morbidity - disease rate; Nutrient; Obesity; Outcome; Patients; Physiologic pulse; Population; Publishing; Quality of life; Randomized; Randomized Clinical Trials; Rehabilitation Outcome; Reporting; Risk; Risk Factors; SF-36; Secondary Prevention; Structure; Survival Rate; Testing; Therapeutic Intervention; Walking; Weight; Woman; Work; aged; arterial stiffness; base; dietary restriction; evidence base; exercise adherence; exercise capacity; exercise prescription; experience; follow-up; high risk population; hospital readmission; improved; improved outcome; indexing; innovation; men; modifiable risk; mortality; novel; obesity treatment; outcome forecast; prognostic; programs; social; standard of care; targeted treatment; therapy design; waist circumference; weight loss intervention

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.

项目概要 冠心病 (CHD) 带来巨大的身体、社会和经济负担，而这种负担 估计有 620 万且数量迅速增加的肥胖先心病患者可能会加剧这种情况。 心脏项目康复有可能显着降低冠心病的发病率和死亡率 然而，基于运动的心脏康复对于提高运动能力和 患有肥胖症的冠心病患者的冠心病危险因素被削弱，因此，这些患者中很大一部分并非如此。 当前护理标准的最佳治疗效果是心脏康复体验计划。 目前由于其持续时间短（3 个月）、对肥胖治疗（营养与热量）关注不足而受到限制 摄入量），并且无法产生有意义的体重减轻（<3%），而多项证据表明 限制热量摄入等可减轻体重和脂肪的策略将改善冠心病患者的预后 针对肥胖症，一项明确的随机临床试验，使用基于证据的减肥方法 需要进行心脏康复设置。本研究的主要目标是检验以下主要假设： 添加新颖的 6 个月行为减肥干预措施（即限制热量饮食和代餐） 以运动为基础的心脏康复将导致运动能力、动脉功能、 我们还将检查身体成分和脂肪分布、生活质量、冠心病危险因素和炎症。 通过在干预后 12 个月重新评估结果来确定短期效益是否能长期维持 完成并探索 3.5 年随访期间对心血管事件和死亡率的影响。 为了实现这一目标，我们将随机抽取 120 名肥胖成年人（BMI ≥30 kg/m2 或腰围 >102 cm） 男性和> 88 厘米的女性）年龄 55-75 岁患有 CHD 单独接受 6 个月的心脏康复 (Rehab) 或 心脏康复加上行为减肥干预（Rehab+WL），以减少身体脂肪。 具体目标是确定康复+WL 与单独康复对运动能力的影响，衡量标准为 6 分钟步行（主要目标）；动脉波反射指数（主动脉增强指数、反射） 幅度、收缩末期负荷）、动脉僵硬度（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（通过 DXA）、身体脂肪分布（通过 CT）、CHD 危险因素 （血脂、血糖、血压）和炎症（次要目标）以及包括所有的复合终点； 在长达 3.5 年的随访期间导致死亡和心血管事件（探索性目标）。 是否有旨在促进有意义的减肥和持续行为改变的新颖干预措施 可以改善肥胖冠心病患者的结局和长期预后，有可能显着改善 推进该领域的发展，并为以肥胖为重点的医疗保健政策变化提供额外支持。 我们的假设将为在心脏康复中添加正式的减肥计划提供强大的推动力 指南并实施针对肥胖先心病患者的新护理模式。