Sustainability of Rehabilitation Gains in COPD

慢性阻塞性肺病康复成果的可持续性

• 批准号: 9038788
• 负责人: Eileen G Collins
• 金额: --
• 依托单位: EDWARD HINES JR VA HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-10-01 至 2018-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9038788
• 关键词: Adherence; Affect; Anxiety; Breathing; Breathing Exercises; Cause of Death; Chronic; Chronic Obstructive Airway Disease; Clinical; Development; Diagnosis; Dimensions; Dyspnea; Effectiveness; Enrollment; Ensure; Exercise; Exercise Tolerance; Exhalation; Fatigue; General Population; Health; Health Care Costs; Home environment; Hospitalization; Impairment; Intention; Intervention; Laboratories; Linear Regressions; Maintenance; Measurement; Measures; Mental Depression; Methods; Modeling; Muscle function; Outcome Measure; Participant; Patients; Pattern; Physical activity; Physicians; Physiological; Psychological Factors; Pulmonary function tests; Qualifying; Quality of life; Randomized; Randomized Controlled Clinical Trials; Rehabilitation therapy; Reporting; Research; Respiratory Muscles; Risk; Sampling; Self Efficacy; Severities; Study Subject; Symptoms; Tail; Techniques; Testing; Time; Training; Treadmill Tests; Ultrasonography; United States; Veterans; Visit; Walking; Work; airway obstruction; base; clinical phenotype; design; disability; exercise program; exercise training; follow-up; functional decline; functional status; health administration; improved; interest; intervention program; mortality; motivational enhancement therapy; muscle strength; novel; primary outcome; programs; psychologic; pulmonary rehabilitation; quadriceps muscle; respiratory; study characteristics; treadmill

DESCRIPTION (provided by applicant): Rationale: Development of dynamic hyperinflation is a primary limiting factor of exercise tolerance in chronic obstructive pulmonary disease (COPD). To lessen the development of dynamic hyperinflation, and to improve exercise tolerance in COPD patients, we have developed a breathing- retraining technique to be used during pulmonary rehabilitation. This breathing-retraining technique is designed to decrease respiratory rate and prolong exhalation. We demonstrated that, in the short- term, hyperinflation and exercise duration improved more with breathing-retraining plus exercise- training than with exercise-training alone. Because a crucial aspect of pulmonary rehabilitation is the maintenance its short-term benefits over the long-term, we now propose to test whether short- term benefits of breathing-retraining plus exercise followed by an adherence-intervention program are sustainable over the long-term Primary Hypothesis: (H1) In COPD patients, improvements in exercise duration on a constant- load treadmill test will be greater after 12 weeks of breathing- retraining plus exercise-training followed by a 42-week adherence-intervention program (1 yr. total) than after 12 weeks of exercise-training alone followed by a 42-week adherence-intervention program (1 yr. total). Secondary Hypotheses: One year after randomization, exercise-induced dynamic hyperinflation will be less during a constant-load treadmill test (H2), 6-minute walking distance will be longer (H3), and mastery over breathing will be greater (H4) in the breathing- retraining plus exercise-training group than in the exercise-alone group. Lastly (exploratory objective), we will assess the effect of the patient's physiologic, psychologic and clinical phenotype on short-term and long-term responsiveness to pulmonary rehabilitation. Methods: The proposed study is a randomized, controlled clinical trial in which 250 patients with moderate-to-severe COPD will be enrolled. One hundred forty of these patients are expected to qualify for randomization into the breathing-retraining plus exercise-training group or the exercise-training alone group. Patients will receive 12-weeks of supervised training according to group assignment (three times weekly) followed by an adherence-intervention program (weekly phone motivational interviews, home-exercise program, and monthly laboratory booster sessions). Follow-up testing will be completed at 12 weeks, and at 6 and 12 months. Testing will include pulmonary function test, incremental-load and constant-load treadmill tests, 6-minute walk test, measurements of dyspnea, assessment of respiratory and quadriceps muscle strength and endurance and quadriceps ultrasonography. Analysis: In the principal analysis of the primary outcome measure (exercise duration; H1) we will compare changes in exercise duration (constant work-rate treadmill test) from baseline to end of study using 2-sample t-test (two-tailed �=.05). The primary analysis will be based on intention-to-treat principles. Multiple imputation will be used for study subjects missing the 12-month measurement. This imputation model will be based on baseline characteristics of study participants. Several secondary analyses of the primary outcome measure will be performed (H2-H4). Linear regression will be used to determine whether the observed treatment benefits persist after adjustment for baseline covariates and measures of adherence to treatment. Since several measurements will be taken on each patient, mixed-models analysis will be used to compare the changes on the constant- load treadmill test over time between the two groups.

描述（由申请人提供）： 理由：动态过度充电的发展是慢性阻塞性肺疾病（COPD）运动耐受性的主要限制因素。为了减少动态性过度充电的发展，为了提高COPD患者的运动耐受性，我们开发了一种在肺部康复过程中使用的呼吸呼吸技术。这种呼吸的技术旨在降低呼吸频率和延长呼气。我们证明，在短期内，过度通货膨胀和运动持续时间与单独的锻炼训练相比，随着呼吸训练以及运动训练加运动训练的改善。由于肺部康复的关键方面是维持其短期的长期益处，我们现在建议测试长期的依从性干预计划在长期的主要假设中是否可持续的短期收益，在长期的主要假设中是可持续的：（H1）在COPD患者中，在不断的锻炼后，在持续的跑步训练中会在不断的锻炼中进行锻炼。仅在单独进行12周的运动训练之后，与42周的依从性干预计划（总计1年），然后是一个为期42周的依从性干预计划（总计1年）。次要假设：在随机化后一年，在恒定负载跑步机测试（H2）期间，运动引起的动态过度充电将较小，步行距离为6分钟（H3），而对呼吸的呼吸训练组则比运动组的运动组更大（H4）。最后（探索目标），我们将评估 患者的生理，心理和临床表型对肺部康复的短期和长期反应性的影响。方法：拟议的研究是一项随机，对照临床试验，其中250例中度至重度COPD患者被招募。这些患者中有140名有资格随机分解呼吸呼吸加上运动训练组或单独运动训练组。患者将根据小组任务（每周三次）接受12周的监督培训，然后进行依从性干预计划（每周电话励志访谈，家庭运动计划和每月的实验室助推器会议）。随访测试将在12周以及6和12个月的时间完成。测试将包括肺功能测试，增量负载和恒定跑步机测试，6分钟的步行测试，呼吸困难的测量，呼吸道和股四头肌的肌肉力量和耐力以及股四头肌超摄影的评估。分析：在对主要结局度量（运动持续时间; H1）的主要分析中，我们将使用2个样本t检验（两尾= .05）比较从基线到研究结束的运动持续时间（恒定工作率跑步机测试）的变化。主要分析将基于意向性治疗原则。多个插补将用于缺少12个月测量的研究对象。该插补模型将基于研究参与者的基线特征。将对主要结局测量进行几个次要分析（H2-H4）。线性回归将用于确定在调整基线协变量和遵守治疗的措施后，观察到的治疗益处是否持续存在。由于将对每位患者进行多次测量，因此将使用混合模型分析来比较两组之间恒定载荷跑步机测试的变化。