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

体力活动促进对慢性阻塞性肺病短期和长期结果的影响

• 批准号: 9016452
• 负责人: Marilyn L. Moy
• 金额: --
• 依托单位: VA BOSTON HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-01 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9016452
• 关键词: Acute; Address; Adherence; Admission activity; Analysis of Variance; Area; Behavioral; Biological Markers; Blood; C-reactive protein; Cardiovascular Diseases; Caring; Cause of Death; Characteristics; Chronic Obstructive Airway Disease; Clinic; Clinic Visits; Clinical; Counseling; Coupled; Cross-Sectional Studies; Diagnosis; Disabled Persons; Disease; Disease Outcome; Dyspnea; Education; Effectiveness; Enrollment; Epidemiology; Exercise; Exercise stress test; Forced expiratory volume function; Functional disorder; Funding; Future; Goals; Health; Health Personnel; Home environment; Hospitalization; Hospitals; ICD-9; Inflammation; Inflammatory; Instruction; Interleukin-6; Internet; Intervention; Knowledge; Lung; Measures; Mediating; Modeling; Monitor; Morbidity - disease rate; Motivation; Outcome; Outpatients; Patients; Peripheral; Persons; Pharmacological Treatment; Phase; Physical activity; Plasma; Prevalence; Pulmonary Function Test/Forced Expiratory Volume 1; Questionnaires; Randomized; Randomized Controlled Trials; Recording of previous events; Recovery of Function; Rehabilitation therapy; Research; Research Support; Respiratory physiology; Risk; Safety; Seasons; Self Management; Services; Shortness of Breath; Site; Skeletal Muscle; Strategic Planning; Symptoms; Systemic disease; Telephone; Testing; Veterans; Walking; Writing; arm; base; burden of illness; disability; functional disability; functional status; health administration; health related quality of life; improved; individualized feedback; mortality; novel; programs; pulmonary function; pulmonary rehabilitation; research and development; respiratory; success; treatment as usual; web site

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.

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中，有9％的门诊退伍军人对COPD进行了ICD-9诊断。在COPD中，呼吸急促会导致身体不活动和严重的残疾。越来越多的知识将体育活动和锻炼确定为可能影响与COPD相关的发病率和死亡率的一个可修改因素。流行病学和横断面研究表明，患有更为活跃的COPD的人具有更好的功能状态，并且不太可能住院和死亡。直接测量时，每日较高的步骤计数与COPD中急性加重（AES）和死亡率的较低风险有关，而与肺功能无关。尽管有潜在的好处，但很少有干预措施可以增加与COPD的人的步行。尽管受监督的肺康复计划提高了运动能力，但所有可以从中受益并依从性较低的人都无法获得运动能力。需要纳入行为改变策略以及可访问，个性化和持续的新颖干预措施，以促进受COPD限制的人的体育锻炼。由RR＆D CDA-2（Moy博士）资助，我们已经开发并试行了一种新颖的运动干预措施，该锻炼将网站与计步器结合在一起，以促进与COPD的人一起行走。该计划的每一步都计算了肺部健康的（ESC），准确地监视步行，提供迭代反馈和个性化目标，并提供教育和动力。 我们提出了一项2臂随机，对照试验，以研究ESC与通常的护理（言语和书面说明）相比，ESC提高COPD的运动能力的功效。主要目的：确定ESC干预措施增加6分钟步行测试（6MWT）距离的功效。次要目的：估计ESC干预对（a）与健康相关的生活质量（HRQL）的影响，如圣乔治呼吸问卷（SGRQ），（b）呼吸困难，（c）炎症生物标志物C-反应性C-反应性蛋白质（CRP）和白介素6（IL-6），（D）与AES和COPD相关住院的风险，以及（e）通过每日步骤计数衡量的体育活动。 185名受试者将总共招收12个月，介入阶段为6个月，随后观察阶段为6个月。受试者将被随机分配给2个武器之一：（1）在家锻炼的口头和书面说明（通常护理）或（2）通常的护理以及计步器和互联网介导的步行计划。受试者将执行6MWT，完整的问卷调查，并在基线，3、6和12个月的诊所就诊时抽血。电话联系将在9个月发生。 AE历史记录和每日步骤计数将在每个联系人时进行评估。方差分析将比较干预措施中的6MWT距离和6个月的常规护理组。多元回归模型将评估6MWT距离作为治疗组的函数，调整基线6MWT距离，研究地点，入学季节以及任何不平衡的基线特征。我们假设与常规护理组的人相比，随机到ESC的人将在6个月时在6个月的距离更高。我们还假设，与对照相比，与对照相比，随机分配到ESC的人将在HRQL，呼吸困难，每日步骤计数以及与AES和COPD相关的住院的风险方面有更大的改善。我们的干预措施有可能（1）为绝大多数无法参加基于医院的肺部康复计划的COPD的人带来锻炼计划，（2）通过维持长期锻炼，提高当前康复计划的有效性， （3）成为COPD自我管理计划的有效和组成部分。最终，干预可能会降低住院，AES和COPD相关的发病率和死亡率的风险。