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: 9136713
• 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/9136713
• 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; Telephone; 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)： 理论基础：慢性阻塞性肺疾病(COPD)患者运动耐量的一个主要限制因素是发生动态恶性通货膨胀。为了减轻COPD患者动态过度充气的发展，并提高运动耐量，我们开发了一种呼吸再训练技术，用于肺康复。这种呼吸再训练技术旨在降低呼吸频率和延长呼气。我们证明，在短期内，呼吸再训练加运动训练比单独运动训练更能改善恶性通货膨胀和运动持续时间。由于肺康复的一个关键方面是长期维持其短期益处，我们现在建议测试呼吸再训练加上运动，然后是坚持干预计划的短期好处是否在长期基本假设中是可持续的：(H1)在COPD患者中，在12周的呼吸再训练加运动训练然后是42周的坚持干预计划(1年)之后，在恒定负荷跑步机测试中运动持续时间的改善将会更大。总计)比单独运动训练12周后，随后42周的坚持干预计划(1年)要好。总计)。第二个假设：随机化一年后，呼吸再训练加运动训练组在恒定负荷跑步机试验(H2)中运动性过度充气较少，6分钟步行距离(H3)较长，对呼吸的掌握(H4)较单纯运动训练组更大。最后(探索性目标)，我们将评估 患者的生理、心理和临床表型对肺康复短期和长期反应的影响。方法：本研究是一项随机对照临床试验，纳入250例中重度COPD患者。其中140名患者预计有资格随机分为呼吸再训练加运动训练组或单独运动训练组。患者将根据小组分配接受为期12周的监督培训(每周三次)，然后进行坚持干预计划(每周电话激励访谈、家庭锻炼计划和每月的实验室强化会议)。随访测试将在12周、6个月和12个月完成。测试将包括肺功能测试、递增负荷和恒定负荷跑步机测试、6分钟步行测试、呼吸困难测量、呼吸和股四头肌肌肉力量和耐力评估以及股四头肌超声波检查。分析：在主要结果测量(运动持续时间；H1)的主要分析中，我们将使用2样本t检验(双尾�=0.05)比较从基线到研究结束时运动持续时间(恒定工作速度跑步机测试)的变化。初步分析将基于意向治疗原则。对于错过12个月测量的研究对象，将使用多重补偿。这一归责模型将基于研究参与者的基线特征。将对主要结果衡量标准进行若干次级分析(H2-H4)。线性回归将用于确定在对基线协变量和坚持治疗的措施进行调整后，观察到的治疗益处是否持续存在。由于将对每个患者进行几次测量，因此将使用混合模型分析来比较两组之间恒定负荷跑步机测试随时间的变化。