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.

项目摘要 冠心病（CHD）给人们带来了巨大的身体、社会和经济负担， 在估计的620万和迅速增长的肥胖CHD患者中可能会加剧。 心脏康复计划有可能显着降低冠心病的发病率和死亡率 患者然而，基于运动的心脏康复对提高运动能力和 冠心病危险因素在合并肥胖的冠心病患者中减弱。因此，这些患者中有很大一部分不是 在当前的护理标准下体验最佳治疗益处。心脏康复计划是 目前，由于其持续时间短（3个月），对肥胖治疗的关注不足（营养与热量）， 摄入量），以及不能产生有意义的体重减轻（<3%）。虽然多方面的证据表明， 减少体重和脂肪的热量限制等策略将改善CHD患者的结局 肥胖症，一项明确的随机临床试验，使用循证方法减肥， 需要心脏康复设施。本研究的主要目的是检验主要假设， 增加一种新的6个月行为减肥干预（即，热量限制饮食与代餐） 以运动为基础的心脏康复将导致运动能力，动脉功能， 身体成分和脂肪分布、生活质量、CHD危险因素和炎症。我们亦会研究 通过在干预后12个月重新评估结果，短期获益是否可长期维持 在3.5年的随访期内完成并探索对心血管事件和死亡率的影响。到 为了实现这一目标，我们将随机选择120名肥胖成年人（BMI ≥30 kg/m2或腰围>102 cm）， 男性和>88 cm的女性），年龄55-75岁，患有CHD，仅接受6个月的心脏康复（康复），或 心脏康复加行为减肥干预（康复+WL），促进体脂减少。的 具体目标是确定康复+WL与单独康复对运动能力的影响， 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，晚期收缩负荷），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（DXA）、体脂分布（CT）、CHD危险因素 （血脂、血糖、血压）和炎症（次要目的）;以及复合终点，包括所有- 在长达3.5年的随访期间导致死亡和心血管事件（探索性目的）。确定 是否新的干预措施，旨在促进有意义的减肥和持续的行为变化， 可改善冠心病合并肥胖患者的预后和远期预后，具有显著的潜力， 推动该领域的发展，并为以肥胖为重点的卫生保健政策改革提供额外支持。确认 我们的假设将为在心脏康复中加入正式的减肥计划提供强大的动力 指南和实施新的模式，为冠心病患者的肥胖。