The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD

描述(由申请人提供)： 慢性阻塞性肺疾病(COPD)是全球发病率的主要原因，预计到2020年将成为世界第三大死亡原因。在退伍军人中，患病率很高；在2012财年的VISN1，9%的门诊退伍军人被诊断为ICD-9慢性阻塞性肺病。在慢性阻塞性肺疾病中，呼吸短促会导致缺乏运动和严重残疾。越来越多的知识发现，体力活动和锻炼是一个可改变的因素，可能会影响COPD相关的发病率和死亡率。流行病学和横断面研究表明，身体活动较多的慢性阻塞性肺病患者的功能状况较好，住院和死亡的可能性较小。每日较高的步数，当直接测量时，与COPD急性加重(AEs)和死亡率的较低风险相关，与肺功能无关。尽管有潜在的好处，但几乎没有干预措施来增加COPD患者的步行。尽管有监督的肺康复计划提高了运动能力，但并不是所有可以从中受益的人都能获得这些计划，而且遵守率很低。需要新的干预措施，纳入行为改变战略，并且是可获得的、个性化的和持续的，以促进受COPD限制的人的体力活动。在RR&D CDA-2(Moy博士)的资助下，我们开发并试验了一种新的运动干预措施，将网站与计步器相结合，以促进COPD患者的步行。该计划名为ESC(ESC)，可准确监测步行情况，提供迭代反馈和个性化目标设定，并提供教育和激励。我们提出了一项双臂随机对照试验，以研究ESC与常规护理(口头和书面锻炼说明)相比，在改善COPD患者运动能力方面的有效性。主要目的：确定ESC干预对增加6分钟步行试验(6MWT)距离的效果。次要目标：评估ESC干预对以下方面的影响：(A)圣乔治呼吸问卷(SGRQ)测量的与健康相关的生活质量(HRQL)；(B)呼吸困难；(C)炎症生物标志物C-反应蛋白(CRP)和白介素6(IL-6)；(D)急性呼吸综合征和慢性阻塞性肺病相关住院的风险；以及(E)每日步数测量的体力活动参与度。185名受试者将入选，为期12个月，干预阶段为6个月，随后是6个月的观察阶段。受试者将被随机(1：1的比例)分为两组：(1)口头和书面的在家锻炼指导(通常的护理)或(2)通常的护理加上计步器和互联网介导的步行计划。受试者将在基线、3个月、6个月和12个月进行6次MWTs，完成问卷调查，并在临床就诊时抽血。电话联系将在9个月后进行。将在每次接触时评估AE病史和每日步数。方差分析将在6个月时比较干预组和常规护理组的6MWT距离。多元回归模型将评估6MWT距离作为治疗组的函数，根据基线6MWT距离、学习地点、注册季节和任何不平衡的基线特征进行调整。我们假设，与常规护理组的患者相比，随机接受ESC的患者在6个月时有更大的6MWT距离。我们还假设，与对照组相比，随机接受ESC治疗的患者在HRQL、呼吸困难、每日步数方面将有更大的改善，炎症生物标志物水平以及与AEs和COPD相关的住院风险将有更大的下降。我们的干预措施有可能(1)为绝大多数不能接受医院肺康复计划的COPD患者提供锻炼计划，(2)通过持续长期锻炼来提高现有康复计划的有效性，以及(3)成为COPD自我管理计划有效和不可或缺的一部分。最终，干预可以降低住院风险、不良反应和COPD相关的发病率和死亡率。

DESCRIPTION (provided by applicant): Chronic obstructive pulmonary disease (COPD) is a major cause of global morbidity and is projected to become the third leading cause of death in the world by 2020. In Veterans, the prevalence is high; in VISN1 in FY 2012, 9% of outpatient Veterans had the ICD-9 diagnosis of COPD. In COPD, shortness of breath leads to physical inactivity and significant disability. A growing body of knowledge has identified physical activity and exercise as a modifiable factor that may impact COPD-related morbidity and mortality. Epidemiological and cross-sectional studies have shown that persons with COPD who are more physically active have better functional status and are less likely to be hospitalized and to die. A higher daily step count, when directly measured, is associated with lower risk of acute exacerbations (AEs) and mortality in COPD, independent of lung function. Despite the potential benefits, there have been few interventions to increase walking in persons with COPD. Although supervised pulmonary rehabilitation programs improve exercise capacity, they are not accessible to all who could benefit from them and have low adherence rates. Novel interventions that incorporate strategies for behavioral change and that are accessible, individualized, and sustained are needed to promote physical activity in persons limited by COPD. Funded by a RR&D CDA-2 (Dr. Moy), we have developed and piloted a novel exercise intervention that combines a website with a pedometer to promote walking in persons with COPD. The program, Every Step Counts (ESC) for Lung Health, accurately monitors walking, provides iterative feedback and individualized goal-setting, and delivers education and motivation. We propose a 2-arm randomized, controlled trial to study the efficacy of ESC to improve exercise capacity in persons with COPD, compared to usual care (verbal and written instructions to exercise). Primary Aim: Determine the efficacy of the ESC intervention to increase 6-minute walk test (6MWT) distance. Secondary Aims: Estimate the effect of the ESC intervention on (a) health-related quality of life (HRQL), as measured by the St. George's Respiratory Questionnaire (SGRQ), (b) dyspnea, (c) inflammatory biomarkers C-reactive protein (CRP) and interleukin-6 (IL-6), (d) risk for AEs and COPD-related hospitalizations, and (e) engagement in physical activity as measured by daily step count. 185 subjects will be enrolled for a total of 12 months, with the interventional phase being 6 months followed by an observational phase of 6 months. Subjects will be randomized (1:1 ratio) to one of 2 arms: (1) verbal and written instructions to exercise at home (usual care) or (2) usual care plus pedometer and Internet- mediated walking program. Subjects will perform 6MWTs, complete questionnaires, and have blood drawn at clinic visits at baseline, 3, 6, and 12 months. Telephone contact will occur at 9 months. AE history and daily step count will be assessed at each contact. Analysis of variance will compare 6MWT distance in the intervention and usual care group at 6 months. Multivariate regression models will assess 6MWT distance as a function of treatment group, adjusting for baseline 6MWT distance, study site, season of enrollment, and any unbalanced baseline characteristics. We hypothesize that persons randomized to ESC will have greater 6MWT distance at 6 months, compared to persons in the usual care group. We also hypothesize that persons randomized to ESC will have greater improvements in HRQL, dyspnea, daily step counts, and greater decreases in levels of inflammatory biomarker and risk for AEs and COPD-related hospitalizations, compared to control. Our intervention has the potential to (1) bring an exercise program to the vast majority of persons with COPD who cannot go to a hospital-based pulmonary rehabilitation program, (2) improve the effectiveness of current rehabilitation programs by sustaining long-term exercise, and (3) become an effective and integral part of COPD self-management programs. Ultimately, the intervention could decrease risk of hospitalizations, AEs, and COPD-related morbidity and mortality.