Health through Obesity care for PatiEnts with COPD (HOPE)

 描述(申请人提供)：约70%的慢性阻塞性肺疾病(COPD)患者肥胖或超重。导致COPD的吸烟还与其他可能导致肥胖和心血管疾病的不良健康习惯有关。慢性阻塞性肺疾病的症状通常是非特异性的，包括呼吸困难和运动不耐受。COPD治疗指南建议逐步升级吸入药物以改善这些症状，但由于证据不足，几乎没有提到同时存在的肥胖或减肥干预的效果。心血管疾病是COPD患者死亡的主要原因，肥胖与心血管疾病的重要危险因素有关，包括血脂异常、高血压和糖尿病。全面的生活方式干预，包括控制卡路里的健康饮食，增加体力活动，以及行为自我管理策略，始终能够产生适度的、临床上显著的体重减轻和相关的心血管风险因素减少。患有COPD的超重和肥胖患者不仅会从适度的体重减轻中获得类似的临床好处，这是一个直观但未经检验的概念。因此，我们建议进行一项高度有效、多中心、患者水平的随机、务实的临床试验，以首次产生关于自我指导的为期12个月的循证生活方式干预的有效性的数据，该干预旨在为超重和肥胖的COPD患者适度减肥和增加体力活动。我们的目标是作为国家心肺和血液研究所“肺试验合作(PTC)的多点临床试验(PTC)”的礼宾领导小组(PLG)，以测试通过24个月的随访，干预参与者是否在体重减轻、6分钟步行试验的运动耐量和Borg呼吸困难评分的呼吸困难方面比常规护理对照组患者有更好的结果。次要结果包括，使用SF-12的一般健康相关生活质量，以及使用Framingham风险评分(包括血脂)、腰围中心性肥胖和血压的主要心血管风险因素。我们将监督在多个临床地点的1000名患者的登记，最终由PTC的网络管理核心(NEMO)选择和签约。作为我们提议的HOPE试验的PLG，我们将与NEMO合作，并将提供试验监督、数据管理和报告以及安全监测。

 DESCRIPTION (provided by applicant): Approximately 70% of patients with Chronic Obstructive Pulmonary Disease (COPD) are obese or overweight. Tobacco smoking that causes COPD also is associated with other poor health habits that can lead to obesity and cardiovascular disease. Symptoms of COPD are often non-specific and include dyspnea and exercise intolerance. COPD treatment guidelines recommend stepped escalation of inhaled medications to improve these symptoms, but make little mention of the effect of co-existing obesity or weight loss interventions because of insufficient evidence. Cardiovascular disease is a leading cause of mortality among patients with COPD, and obesity is associated with important risk factors for cardiovascular disease including dyslipidemia, hypertension, and diabetes. Comprehensive lifestyle interventions that include calorie-controlled healthy eating, increased physical activity, and behavioral self-management strategies consistently result in modest, clinically significant weight loss and associated reductions in cardiovascular risk factors. That overweight and obese patients with COPD would not only reap similar clinical benefits from modest weight loss is an intuitive - but untested - concept. Therefore, we propose to conduct a highly valid, multicenter, patient-level randomized, pragmatic clinical trial to produce first-ever data on the effectiveness of a self-directed 12-month evidence-based lifestyle intervention targeting modest weight loss and increased physical activity among overweight and obese patients with COPD. We aim to serve as a Protocol Leadership Group (PLG) for the National Heart, Lung, and Blood Institute's "Multi-Site Clinical Trials for the Pulmonary Trials Cooperative (PTC)" in order to test if intervention participants have better outcomes through 24 months of follow-up compared to usual care control patients in terms of weight loss, exercise tolerance using the 6-Minute Walk Test, and dyspnea using the Borg dyspnea score. Secondary outcomes include, generic health-related quality of life using the SF-12, and major cardiovascular risk factors using Framingham risk score (including lipids), central obesity by waist circumference and blood pressure. We will oversee enrollment of 1000 patients at multiple clinical sites eventually chosen and contracted by the PTC's Network Management Core (NEMO). As the PLG for our proposed HOPE trial, we will cooperate with NEMO and will provide trial oversight, data management and reporting, and safety monitoring.