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: 10492727
• 负责人: Jacquelyn P Kulinski
• 金额: $ 33.14万
• 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/10492727
• 关键词: Adverse event; Affective; Age; Arthritis; Arts; Attitude; Behavior; Biofeedback; Biological; Biological Markers; Cardiac; Cardiac rehabilitation; Cardiovascular Diseases; Cardiovascular system; Chronic Obstructive Pulmonary 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; 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; chronic respiratory disease; 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) 每年夺去的生命比癌症和慢性呼吸道疾病还要多 参与心脏康复 (CR) 可以降低死亡率和重大心血管事件的风险。 在二级预防人群中，包括老年人，参与 CR 的可能性较小。 该人群的合并症，包括关节炎和慢性阻塞性肺病，使得参与 唱歌是一项涉及迷走神经成分的身体活动，表现为变化。 与体育锻炼不同，唱歌对心血管健康的影响并不大。 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。 我们的假设是老年 CVD 患者的心血管状况将得到有利的改善 唱歌 30 分钟后的生物标志物，包括内皮功能和心率变异性 (HRV)。 我们的飞行员 23 名受试者的数据提供了原理证明，外周血管有微小但显着的改善 该初步研究显示了唱歌 10 分钟后的内皮功能（通过外周动脉张力测定法测量）。 帮助我们优化了该提案的临床试验设计，其中将包括更有针对性的人群， 结合个人音乐偏好、增加歌唱持续时间、包括音乐治疗师和 测量肱动脉血流介导的扩张 (FMD)，这是血管测量的“金标准” 内皮功能，作为我们的主要成果，旨在创建、优化和测试两种不同的结果。 根据一项随机研究，该研究将包括三个组。 单盲、交叉、假程序控制设计，总共 65 名参与者将每人进行 3 次访问。 在三个不同的场合进行以下干预：(1) 30 分钟的指导歌唱时间 个人音乐治疗师，(2) 30 分钟的一段时间，跟着教授的教学视频唱歌 声音和“缺乏经验、年龄较大的歌唱学生”以及 (3) 30 分钟的休息时间，无需任何干预。 将使用生物反馈（目标心率和感知用力的 BORG 评级）来帮助受试者优化 该提案的（2 年）R61 阶段将评估音乐干预对心血管的影响。 执行拟议研究设计（目标 1）的可行性（实施、实用性和可接受性）。 预计 R33 阶段将需要 3 年时间才能完成，R61/R33 合并阶段将受到密切监控。 有能力评估 FMD 和 HRV 的变化（主要和次要结果，目标 2a 和 2b）。 目标 3 中的替代机制将通过测量来探索唱歌对心理健康和福祉的影响 唾液皮质醇和细胞因子，并使用经过验证的视觉情绪评分来评估表演艺术 我们将确定哪种歌唱干预（如果有）优于另一种 – 因为这对于指导该领域更长期、更大规模的临床试验非常重要。 该提案将提高我们对歌唱行为生物学机制的理解，因为它与心血管疾病有关。