Increasing Physical Activity in COPD Through Rhythmically Enhanced Music

理论基础：在COPD患者中，以医院为基础的肺康复可以改善症状、功能状态和 提高生活质量，减少计划外医生就诊、急诊室就诊、住院治疗，可能还包括 死亡率。尽管疗效得到了很好的证明，但由于不足，以医院为基础的康复治疗仍然不够 获取、接受和可持续发展。这引发了人们对以家庭为基础的康复计划日益增长的兴趣。 然而，参加家庭计划的患者可能会进行低强度运动，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是至关重要的 减少运动引起的呼吸困难和疲劳的计划，同时确保足够的运动强度 产生可持续的生理效益。最近的数据表明，节律性增强刺激(RAS) 使用音乐可能构成了这样一种创新策略。音乐可以减少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好处。乐谱 也会导致运动反应的缠绕，如行走。因此，我们计划利用这两个 步态与RAS增强音乐的感觉运动耦合及音乐对运动诱导的缓解作用 呼吸困难/疲劳。具体地说，我们建议比较为期12周的居家锻炼计划的效果 在为期12周的传统家庭锻炼计划中增加了患者定制的RAS增强音乐 慢性阻塞性肺疾病患者。假设：(H1)与随机接受基于家庭的锻炼计划的患者进行比较 在没有音乐的情况下(对照组)，患者随机进入以家庭为基础的锻炼计划，并增加RAS- 增强音乐(干预组)将在6分钟内表现出(H1a，主要假设)更大的增长 步行距离，(H1b)在恒定负荷跑步机测试方案中步行时间增加更多，(H1c)减少 在恒定负荷跑步机测试方案期间出现呼吸困难，以及(H1d)健康相关质量的更大提高 生活。另外(H2)，他们会积累更多的体力活动(动作图)，而(H3)会更好 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 生理心理表型和临床因素对康复反应(持续时间)的影响 恒定负荷跑步机测试)在同时使用RAS-MUSIC和不同时使用RAS-MUSIC的情况下实现。方法：建议的 这项研究是一项随机对照临床试验，170名患者将被随机分成一组， 没有音乐的锻炼计划，或者有RAS增强音乐的家庭锻炼计划。 患者将接受为期12周的以家庭为基础的培训，每组分配(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。测试将在以下地点进行 治疗前、治疗后6、12、24周。测试将包括肺功能测试，6分钟步行测试，恒定- 负荷踏车试验、体力活动量化、呼吸困难、生活质量和目标的测量 股四头肌大小的量化(超声检查)和强度/疲劳(磁刺激 股神经)。分析：在主要结果衡量标准(6分钟步行距离)的主要分析中，我们 将使用混合模型分析，其中包括治疗、时间和逐个时间治疗的相互作用术语。这 模型将自动考虑丢失的数据-假设丢失是随机的。我们将进行一项 根据混合模型分析的结果进行敏感性分析，以确定哪些其他假设 对于丢失的数据，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 对基线人口和健康协变量进行调整。一种线性回归模型和一种混合模型 方差分析将用于评估临床混杂因素的影响(探索性目标)。科学 贡献：这些数据将为确定我们康复的生理影响提供坚实的基础 策略。这一创新、实用和经济的肺康复战略有可能创造 许多COPD退伍军人的护理模式发生了转变，这些退伍军人无法获得肺部康复。

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.