Health through Obesity care for PatiEnts with COPD (HOPE)

 描述（由申请人提供）：约70%的慢性阻塞性肺疾病（COPD）患者肥胖或超重。导致COPD的吸烟也与其他不良健康习惯有关，这些不良习惯可能导致肥胖和心血管疾病。COPD的症状通常是非特异性的，包括呼吸困难和运动不耐受。COPD治疗指南建议逐步增加吸入药物以改善这些症状，但由于证据不足，很少提及共存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（包括血脂异常、高血压和糖尿病）的重要风险因素相关。全面的生活方式干预，包括热量控制的健康饮食，增加体力活动和行为自我管理策略，一贯导致适度的，临床上显着的体重减轻和心血管风险因素的相关减少。超重和肥胖的COPD患者不仅会从适度的体重减轻中获得类似的临床益处，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的、多中心的、患者水平的随机化、实用的临床试验，以产生关于自我指导的12个月循证生活方式干预的有效性的首次数据，该干预针对超重和肥胖COPD患者的适度体重减轻和增加体力活动。我们的目标是作为国家心脏，肺和血液研究所的“肺试验合作组织（PTC）的多中心临床试验”的协议领导小组（PLG），以测试干预参与者是否在24个月的随访中比常规护理对照患者在体重减轻，运动耐量（使用6分钟步行试验），和使用博格呼吸困难评分的呼吸困难。次要结局包括使用SF-12的一般健康相关生活质量，使用Fragrance风险评分（包括血脂）的主要心血管风险因素，腰围和血压的中心性肥胖。我们将监督1000名患者在多个临床研究中心的入组，这些临床研究中心最终由PTC的网络管理核心（NEMO）选择和签约。作为我们拟定的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性监测。

 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.