Increasing Physical Activity in COPD Through Rhythmically Enhanced Music

依据：在COPD中，以医院为基础的肺康复可以改善症状、功能状态， 生活质量和减少计划外的医生访问，急诊室访问，住院治疗，并可能， mortality.尽管疗效有据可查，但由于缺乏足够的药物， 获取、接受和可持续性。这引发了人们对家庭康复计划越来越大的兴趣。 然而，参加家庭项目的患者可以低强度运动以避免呼吸困难/疲劳， 限制了运动训练的潜在益处。因此，发展创新的家庭基础设施至关重要。 减少运动引起的呼吸困难和疲劳，同时确保足够的运动强度， 产生持续的生理效益。最近的数据表明，节律性增强刺激（RAS） 利用音乐可以构成这样一种创新策略。音乐可以减轻运动引起的呼吸困难/疲劳 使患者能够忍受更具挑战性的体力活动，并从康复中获得更大的益处。音乐 也可引起运动反应如行走的夹带。因此，我们计划利用 RAS增强的音乐与步态的感觉运动耦合以及音乐对运动诱导的 呼吸困难/疲劳。具体来说，我们建议比较一个为期12周的，以家庭为基础的锻炼计划的疗效 通过患者量身定制的RAS增强型音乐增强12周的传统家庭锻炼计划， COPD患者。假设：（H1）与随机分配至家庭锻炼计划的患者相比 没有音乐（对照组），患者随机分配到一个以家庭为基础的运动计划， 强化音乐（干预组）将证明（H1 a，主要假设）6分钟内 步行距离，（H1b）在恒定负荷跑步机测试方案上步行时间增加更多，（H1 c）减少 在恒定负荷跑步机测试协议期间的呼吸困难，和（H1 d）健康相关质量的更大增加， 生活此外（H2），他们将积累更多的身体活动量（活动记录）和（H3）将更好地 随着时间的推移保持这些好处。最后（探索性目标），我们将评估机械影响 生理和心理表型以及临床因素对康复反应性的影响（持续时间 恒定负荷跑步机试验），同时使用和不使用RAS音乐。方法：建议 研究是一项随机对照临床试验，其中170名患者将被随机分配到一个以家庭为基础， 没有音乐的锻炼计划或用RAS增强的音乐增强的基于家庭的锻炼计划。 患者将接受12周的家庭培训（每周至少三次）， 通过12周的随访来评估我们新干预措施的可持续性。测试将在 基线和第6、12和24周。测试将包括肺功能测试，6分钟步行测试，恒定- 运动负荷试验、体力活动量化、呼吸困难测量、生活质量和客观 量化股四头肌尺寸（超声检查）和强度/疲劳（磁刺激） 股神经）。分析：在主要结局指标（6分钟步行距离）的主要分析中， 将使用混合模型分析，包括治疗、时间和治疗-时间相互作用项。这 模型将自动考虑缺失数据-假设随机缺失。我们将进行 根据混合模型分析的结果进行敏感性分析，以确定其他假设 数据缺失可能会产生不同的结果。敏感性分析的一个组成部分将包括 对基线人口统计学和健康协变量进行调整。线性回归模型和混合模型 将使用ANOVA评估临床混杂因素的影响（探索性目的）。科学 贡献：这些数据将为确定我们康复治疗的生理影响提供坚实的基础 战略这种创新、实用和经济的肺康复策略有可能创造 许多患有COPD的退伍军人无法获得肺康复治疗，这是护理的一个范式转变。

Rationale: In COPD, hospital-based pulmonary rehabilitation can improve symptoms, functional status, and quality of life and decrease unscheduled physician visits, emergency room visits, hospitalizations, and possibly, mortality. Despite the well documented efficacy, hospital-based rehab remains inadequate due to insufficient access, acceptance and sustainability. This has triggered a growing interest in home-based rehab programs. Patients enrolled in home-based programs, however, may exercise at low intensities to avoid dyspnea/fatigue, limiting the potential benefits of exercise training. Accordingly, it is essential to develop innovative home-based programs that decrease exercise-induced dyspnea and fatigue while ensuring sufficient exercise intensity to produce sustainable physiologic benefit. Recent data suggest that rhythmically enhanced stimulation (RAS) using music may constitute such an innovative strategy. Music can diminish exercise-induced dyspnea/fatigue allowing patients to tolerate more challenging physical activity and obtain a greater benefit from rehab. Music also can induce entrainment of motor responses such as walking. We thus plan to capitalize on both the sensorimotor coupling of gait with RAS-enhanced music and the mitigating effect of music over exercise-induced dyspnea/fatigue. Specifically, we propose to compare the efficacy of a 12-week, home-based exercise program augmented by patient-tailored, RAS-enhanced music to a 12-week traditional home-based exercise program in patients with COPD. Hypothesis: (H1) Compared to patients randomized to a home-based, exercise program without music (control group), patients randomized to a home-based, exercise program augmented with RAS- enhanced music (intervention group) will demonstrate (H1a, primary hypothesis) greater increase in 6-minute walk distance, (H1b) greater increase in walking time on a constant-load treadmill test protocol, (H1c) reduced dyspnea during a constant-load treadmill test protocol, and (H1d) greater increases in health-related quality of life. In addition (H2), they will accumulate greater volume of physical activity (actigraphy) and (H3) will better sustain these benefits over time. Lastly (Explorative Objective), we will assess the mechanistic impact physiological and psychological phenotype and clinical factors on responsiveness to rehabilitation (duration constant-load treadmill test) achieved with and without concurrent use of RAS-music. Methods: The proposed study is a randomized, controlled clinical trial in which 170 patients will be randomized into a home-based, exercise program without music or a home-based exercise program augmented with RAS-enhanced music. Patients will receive 12-weeks of home-based training per group assignment (at least three times weekly) followed by 12-weeks of follow-up to assess the sustainability of our novel intervention. Testing will be carried out at baseline and at 6, 12 and 24 weeks. Testing will include pulmonary function test, 6-minute walk tests, constant- load treadmill test, physical activity quantification, measurements of dyspnea, quality of life, and objective quantification of quadriceps dimensions (ultrasonography) and strength/fatigue (magnetic stimulation of the femoral nerve). Analysis: In the principal analysis of the primary outcome measure (6-minute walk distance) we will use a mixed-model analysis that includes treatment, time and treatment-by-time interaction terms. This model will automatically account for missing data—where missing at random is assumed. We will conduct a sensitivity analysis based on the results of the mixed model analysis to determine which other assumptions regarding missing data might produce different results. One component of the sensitivity analysis will include adjustment for baseline demographic and health covariates. A linear regression model and a mixed model ANOVA will be used to assess the impact of clinical confounders (Explorative Objective). Scientific contribution: These data will provide a solid foundation to determine the physiologic impact of our rehab strategy. This innovative, practical and economical pulmonary rehabilitation strategy has the potential to create a paradigm shift in the care of the many veterans with COPD who have no access to pulmonary rehabilitation.