Increasing Physical Activity in COPD Through Rhythmically Enhanced Music

理由：对于慢性阻塞性肺病，以医院为基础的肺康复可以改善症状、功能状态和 生活质量并减少计划外就诊、急诊室就诊、住院治疗，甚至可能， 死亡率。尽管疗效有据可查，但由于缺乏足够的资源，以医院为基础的康复治疗仍然不足。 获取、接受和可持续性。这引发了人们对家庭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锻炼，以避免呼吸困难/疲劳， 限制运动训练的潜在益处。因此，开发创新型家居产品势在必行。 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 让患者能够忍受更具挑战性的身体活动并从康复中获得更大的益处。音乐 也可以诱导运动反应，例如行走。因此，我们计划利用 步态与 RAS 增强音乐的感觉运动耦合以及音乐对运动诱发的缓解作用 呼吸困难/疲劳。具体来说，我们建议比较为期 12 周的家庭锻炼计划的效果 在为期 12 周的传统家庭锻炼计划中加入为患者量身定制的 RAS 增强音乐 慢性阻塞性肺病患者。假设：(H1) 与随机接受家庭锻炼计划的患者相比 在没有音乐的情况下（对照组），患者被随机分配到以家庭为基础的锻炼计划，并辅以 RAS- 增强音乐（干预组）将证明（H1a，主要假设）在 6 分钟内有更大的增加 步行距离，(H1b) 在恒定负载跑步机测试方案中步行时间增加更多，(H1c) 减少 在恒定负载跑步机测试方案中出现呼吸困难，并且 (H1d) 与健康相关的质量有更大的提高 生活。此外（H2），他们将积累更大的身体活动量（体动记录仪）并且（H3）会更好 随着时间的推移维持这些好处。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对康复反应的临床因素（持续时间 恒定负载跑步机测试）在同时使用和不使用 RAS 音乐的情况下实现。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家庭、 无音乐的锻炼计划或添加 RAS 增强音乐的家庭锻炼计划。 患者将接受每组任务为期 12 周的家庭训练（每周至少 3 次） 通过 12 周的随访来评估我们新颖干预措施的可持续性。测试将于 基线以及第 6、12 和 24 周时。测试将包括肺功能测试、6 分钟步行测试、持续- 负荷跑步机测试、体力活动量化、呼吸困难测量、生活质量和目标 股四头肌尺寸的量化（超声检查）和强度/疲劳（股四头肌的磁刺激） 股神经）。分析：在主要结果指标（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、时间和治疗与时间的相互作用项。这个 模型将自动考虑丢失的数据——假设随机丢失。我们将进行一次 敏感性分析基于混合模型分析的结果来确定哪些其他假设 关于缺失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 调整基线人口和健康协变量。线性回归模型和混合模型 方差分析将用于评估临床混杂因素的影响（探索性目标）。科学的 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。这种创新、实用且经济的肺康复策略有潜力创造 这是对许多患有慢性阻塞性肺病但无法接受肺康复的退伍军人的护理模式的转变。

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.