Evaluating the Impact of Singing Interventions on Markers of Cardiovascular Health in Older Patients with Cardiovascular Disease

评估歌唱干预对老年心血管疾病患者心血管健康指标的影响

• 批准号: 10462121
• 负责人: Jacquelyn P Kulinski
• 金额: $ 32.92万
• 依托单位: MEDICAL COLLEGE OF WISCONSIN
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10462121
• 关键词: Adverse event; Affective; Age; Arthritis; Arts; Attitude; Behavior; Biofeedback; Biological; Biological Markers; Cardiac; Cardiac rehabilitation; Cardiovascular Diseases; Cardiovascular system; Chronic; Chronic Obstructive Airway Disease; Chronic lung disease; Clinical; Clinical Trials; Clinical Trials Design; Complex; Coronary Arteriosclerosis; Data; Dropout; Elderly; Endothelium; Enrollment; Event; Exertion; Future; Gold; Heart; Heart Rate; Hormones; Hydrocortisone; Inflammatory; Instruction; Intervention; Knowledge; Lung diseases; Malignant Neoplasms; Measurement; Measures; Mediating; Mental Health; Microcirculation; Moods; Morbidity - disease rate; Music; Nerve; Participant; Patient Self-Report; Perception; Peripheral; Personal Satisfaction; Persons; Phase; Physical Exercise; Physical Rehabilitation; Physical activity; Pilot Projects; Population; Procedures; Process; Psyche structure; Randomized; Recording of previous events; Regulation; Research; Research Design; Resources; Rest; Risk; Salivary; Secondary Prevention; Single-Blind Study; Sinoatrial Node; Sinus; Stress; Students; Study Subject; Target Populations; Testing; Translating; Vascular Endothelium; Visit; Visual; Voice; aging population; arm; arterial tonometry; biobehavior; brachial artery; burden of illness; cardiovascular health; cardiovascular stress test; comorbidity; cytokine; design; experience; health care settings; heart rate variability; hemodynamics; improved; innovation; mortality; mortality risk; older patient; performing art; preference; prevent; primary outcome; professor; programs; respiratory; saliva sample; salivary assay; secondary outcome; stressor

Project Abstract Cardiovascular disease (CVD) claims more lives each year than cancer and chronic respiratory disease combined. Participation in cardiac rehabilitation (CR) reduces mortality and risk of a major cardiovascular event in secondary prevention populations, including older adults. Older adults are less likely to participate in CR, as comorbidities in this population, including arthritis and chronic obstructive pulmonary disease, make participation difficult. Singing is a physical activity that involves components of the vagal nerves manifested as changes in cardiac autonomic regulation. Unlike physical exercise, the effects of singing on cardiovascular health has not been well-studied. To our knowledge, no studies have evaluated the impact of singing on important cardiac biomarkers. Our hypothesis is that older patients with CVD will have favorable improvement in cardiovascular biomarkers, including, endothelial function and heart rate variability (HRV), after 30 minutes of singing. Our pilot data in 23 subjects provides proof of principle, with a small, but significant, improvement in peripheral vascular endothelial function (measured by peripheral arterial tonometry) after 10 minutes of singing. This pilot study has helped us optimize the clinical trial design for this proposal, which will include a more targeted population, incorporation of personal music preferences, increased duration of singing, inclusion of a music therapist and measurement of brachial artery flow-mediated dilation (FMD), the “gold standard” measurement for vascular endothelial function, as our primary outcome. Our proposal seeks to create, optimize and test two different singing interventions in older patients with CVD. The study will consist of three arms, according to a randomized, single-blind, crossover, sham procedure-controlled design. Sixty-five total participants will each have three visits on three different occasions for the following interventions: (1) a 30-minute period of guided singing from an in- person music therapist, (2) a 30-minute period of singing along to an instructional video including a professor of voice and “inexperienced, older singing student” and (3) a 30-minute rest period without any intervention. We will use biofeedback (target heart rate and BORG Rating of Perceived Exertion) to help subjects optimize the cardiovascular impact of the music interventions. The (2-year) R61 phase of this proposal will assess the feasibility (implementation, practicality, and acceptability) of executing the proposed study design (Aim 1). We anticipate that the R33 phase will take 3 years to complete. The combined R61/R33 phases will be statistically powered to assess changes in FMD and HRV (primary and secondary outcomes, Aims 2a and 2b). An alternative mechanism in Aim 3 will explore the impact of singing on mental health and well-being by measuring salivary cortisol and cytokines and by using a validated visual mood score designed to evaluate performing arts activities in healthcare settings. We will determine which singing intervention, if any, is superior to the other – as this would be important to guide longer and larger clinical trials in the field. Knowledge gained from this proposal will improve our understanding of biologic mechanisms of singing behaviors, as it relates to CVD.

项目摘要 心血管疾病（CVD）比癌症和慢性呼吸道疾病拥有更多的生命 合并。参加心脏康复（CR）降低了重大心血管事件的死亡率和风险 在包括老年人在内的二级预防人群中。老年人不太可能参加CR，因为 该人群的合并症，包括关节炎和慢性阻塞性肺部疾病，使参与 难的。唱歌是一种体育锻炼，涉及迷走神经的组成部分，表现为变化 心脏自主法规。与体育锻炼不同，唱歌对心血管健康的影响尚未 经过充分研究。据我们所知，没有研究评估唱歌对重要心脏的影响 生物标志物。 我们的假设是，患有CVD的老年患者的心血管有利 唱歌30分钟后，包括内皮功能和心率变异性（HRV），包括内皮功能和心率变异性（HRV）。 我们的飞行员 23个受试者的数据提供了原理证明，其周围血管的较小但显着改善 唱歌10分钟后，内皮功能（通过周围动脉刺激法测量）。该试点研究有 帮助我们优化该提案的临床试验设计，其中将包括一个更具针对性的人群 纳入个人音乐偏好，唱歌持续时间，包括音乐治疗师和 臂动脉流介导的词典（FMD）的测量，血管的“金标准”测量 内皮功能，作为我们的主要结果。我们的建议旨在创建，优化和测试两个不同的 CVD患者的老年患者的唱歌干预措施。根据一个随机，该研究将由三个臂组成 单盲，跨界，假手术控制的设计。共六十五个参与者将分别进行三次访问 在以下干预措施的三个不同情况下 人音乐治疗师，（2）与教学视频一起演唱了30分钟的时期 声音和“经验不足，年长的唱歌学生”和（3）30分钟的休息时间没有任何干预。我们 将使用生物反馈（目标心率和感知劳累的Borg评级）来帮助受试者优化 音乐干预的心血管影响。该提案的（2年）R61阶段将评估 执行拟议的研究设计的可行性（实施，实用性和可接受性）（AIM 1）。我们 预计R33阶段将需要3年才能完成。合并的R61/R33阶段将在统计上是 有动力评估FMD和HRV的变化（主要和次要结果，AIMS 2A和2B）。一个 AIM 3中的替代机制将通过衡量唱歌对心理健康和福祉的影响 唾液皮质醇和细胞因子，并使用旨在评估表演艺术的经过验证的视觉情绪评分 医疗机构的活动。我们将确定哪种唱歌干预（如果有的话）优于另一个 - 因为这对于指导该领域的更长和更大的临床试验非常重要。从中获得的知识 提案将提高我们对与CVD有关的唱歌行为的生物学机制的理解。