Meditation and Exercise for Preventing Acute Respiratory Infection (MEPARI-2)

预防急性呼吸道感染的冥想和运动（MEPARI-2）

• 批准号: 8216899
• 负责人: BRUCE P BARRETT
• 金额: $ 75.15万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8216899
• 关键词: Absenteeism; Acute; Acute respiratory infection; Affect; Area Under Curve; Attention; Behavioral; Blinded; Clinical; Common Cold; Computer Assisted; Control Groups; Data; Economics; Educational Intervention; Emotions; Enrollment; Equation; Exercise; Funding; Goals; Health; Health Care Visit; Health care facility; Human; Human Resources; IL8 gene; Illness Days; Immune system; Incidence; Inflammatory; Influenza; Interleukin-6; Interleukin-8; Interleukins; Intervention; Intervention Studies; Knowledge; Lead; Linear Models; Link; Location; Maintenance; Measures; Mediating; Mediation; Mediator of activation protein; Meditation; Mental Health; Methodology; Methods; Modeling; Monitor; Morbidity - disease rate; Nasal Lavage Fluid; National Center for Complementary and Alternative Medicine; Nose; Outcome; Participant; Pathway interactions; Patient Self-Report; Pattern; Policies; Polymerase Chain Reaction; Population; Process; Productivity; Questionnaires; Randomized; Randomized Controlled Trials; Recruitment Activity; Reporting; Research; Respiratory Tract Infections; Sample Size; Sampling; Schools; Seasons; Self Efficacy; Severities; Sleep; Social support; Statistical Models; Stress; Surveys; Symptoms; Telephone; Testing; Time; Training; Training Programs; Translational Research; Virus; Visit; Waiting Lists; Weight; Wisconsin; Woman; Work; aged; arm; burden of illness; clinical practice; cohort; comparative effectiveness; comparison group; cost effectiveness; cytokine; disorder prevention; flu; follow-up; group intervention; health care service utilization; improved; lost work time; men; mindfulness meditation; mortality; neutrophil; physical conditioning; prevent; primary outcome; programs; psychosocial; randomized trial; respiratory; respiratory virus; secondary outcome

DESCRIPTION (provided by applicant): Preliminary evidence suggests that 8-week training programs in meditation and exercise lead to reductions in incidence, duration and severity of acute respiratory infection (ARI) illness. In this parallel 3-group trial, women and men aged 30 to 69 will be randomized to: 1) an 8-week behavioral training program in mindfulness meditation, 2) an intensity, duration and location-matched 8-week exercise program, or 3) a wait-list observational control group. Recruitment will target those who do not exercise regularly, have not had training in meditation, and report levels of stress at or above average population levels. The primary outcome will be severity-weighted total days of ARI illness as assessed by self-reports on the validated Wisconsin Upper Respiratory Symptom Survey (WURSS-24). Weekly computer-assisted telephone monitoring for ARI illness will be operated by personnel blinded to intervention group. For each ARI illness episode, nasal samples will be tested with multiplex PCR (polymerase chain reaction) to identify viruses, and will be analyzed for neutrophil count, interleukin-6, and interleukin-8 concentrations. ARI-related visits to health care facilities and time lost from work and school will be documented, and assessed as secondary outcomes. Questionnaire measures assessing perceived stress, positive and negative emotion, self-efficacy, social support, sleep quality and general mental and physical health will be analyzed as potential mediators of causal pathways leading from behavioral training interventions to ARI illness outcomes. This will be a 5-year project, with 4 yearly cohorts of n=99 per cohort randomized into 3 groups of n=33 each. Assuming 9% loss to follow-up, the final sample size will be n=360 study participants, with n=120 in each comparison group. Enrollment, randomization and study interventions will begin in September. Participants will be monitored by weekly self-report through May. Summers will be used for data cleaning, preliminary analyses, and for recruiting the next year's cohort. Zero-inflated multivariate regression models will assess effects of meditation and exercise on ARI illness, health care utilization, and work absenteeism. Psychosocial measures will be assessed as potential mediators of effects of meditation and exercise on ARI illness. Generalized estimating equations, random-effects pattern-mixture models, and hierarchical linear models will be used to assess longitudinal effects, interactions, and covariate mediation. PUBLIC HEALTH RELEVANCE: The primary goal of this project is to determine whether behavioral training in mindfulness meditation or moderate intensity sustained exercise can lead to reductions in acute respiratory infection (ARI) illness, such as common cold and influenza. Our preliminary findings suggest substantial benefit of these interventions in terms of reduced incidence, duration and severity of ARI illness, with corresponding reductions in days of work lost to illness. If the proposed research confirms these findings, there will be major implications for public and private health-related policy and practice, as well as for scientific knowledge regarding health maintenance and disease prevention.

描述(由申请者提供)：初步证据表明，为期8周的冥想和锻炼训练计划可以减少急性呼吸道感染(ARI)疾病的发生率、持续时间和严重程度。在这项平行的三组试验中，年龄在30岁到69岁之间的女性和男性将被随机分为：1)为期8周的正念冥想行为训练计划，2)强度、持续时间和地点相匹配的8周锻炼计划，或3)等待名单观察控制组。招募对象将是那些不经常锻炼、没有接受过冥想训练、报告压力水平达到或高于平均人口水平的人。主要结果将是根据经过验证的威斯康星州上呼吸道症状调查(WURSS-24)的自我报告评估的严重程度加权的ARI疾病总天数。每周对ARI疾病进行计算机辅助电话监测，由干预组盲人操作。对于每一次ARI疾病发作，将用多重PCR(聚合酶链式反应)检测鼻样以识别病毒，并将分析中性粒细胞计数、白介素6和白介素8浓度。与ARI有关的对卫生保健机构的访问以及从工作和学校损失的时间将被记录下来，并作为次要结果进行评估。评估感知压力、积极和消极情绪、自我效能感、社会支持、睡眠质量以及一般心理和身体健康的问卷测量将被分析为从行为训练干预到ARI疾病结果的因果路径的潜在中介因素。这将是一个为期5年的项目，每年4个队列，每个队列n=99，随机分为3个组，每个组33个。假设随访损失9%，最终样本量为n=360名研究参与者，每个对照组n=120名。登记、随机和研究干预将于9月份开始。参与者将通过每周自我报告的方式进行监测，直至5月。萨默斯将被用于数据清理、初步分析和招募下一年的队列。零膨胀多元回归模型将评估冥想和锻炼对ARI疾病、医疗保健利用和缺勤的影响。心理社会措施将被评估为冥想和锻炼对ARI疾病影响的潜在中介。广义估计方程、随机效应模式混合模型和分层线性模型将用于评估纵向效应、交互作用和协变量中介。 公共卫生相关性：该项目的主要目标是确定正念冥想或中等强度持续运动中的行为训练是否可以减少普通感冒和流感等急性呼吸道感染(ARI)疾病的发生。我们的初步发现表明，这些干预措施在减少ARI疾病的发病率、持续时间和严重程度方面有很大好处，相应地减少了因病失去的工作天数。如果拟议的研究证实了这些发现，将对公共和私人卫生相关的政策和实践以及关于健康维护和疾病预防的科学知识产生重大影响。