Meditation and Exercise for Prevention of Acute Respiratory Infection

背景：初步证据表明，冥想和运动可能通过相互作用的心理和生理途径来刺激免疫系统和减少传染病。方法：在本研究中，50岁及以上的女性和男性将被随机分为：1)8周的正念冥想行为训练计划，2)强度，持续时间和地点匹配的8周运动训练计划，或3)健康教育课程注意对照组。样本量为N=333，每组N=111。主要结果将是8个月观察期间急性呼吸道感染（ARI）疾病的严重调整总天数，由威斯康星州上呼吸道症状调查（一种有效的问卷结果测量）自我报告。基于核酸的病毒鉴定将验证感染。在ARI疾病期间，将分析洗鼻的炎症标志物IL-8和鼻中性粒细胞计数。次要结果免疫生物标志物将包括对流感免疫的抗体反应（血清IgG，粘膜IgA）和细胞因子IFN-？和IL-10。评估感知压力、积极和消极情绪、乐观和焦虑的问卷测量将作为免疫调节的潜在介质进行分析。时间框架/后勤：这将是一个为期4年的项目，每年有3个队列（第一年N=75；第二年和第三年N=129）。每年的队列将在1月至8月进行筛选，9月进行短暂的依从性评估磨合试验，然后同意并从10月开始随机接受冥想、锻炼或对照组。三价流感疫苗接种将在11月的第6周进行。将在基线、8周疗程结束时和3个月后再次抽血检测抗体滴度和体外细胞因子。同时用鼻拭子检查IgA。参与者将每两周进行一次电话联系，每月进行问卷调查，并在ARI疾病发作期间进行每日自我评估。分析：基于方差分析的模型评估冥想和运动对免疫标志物和ARI疾病的影响。心理测量将被评估为冥想和运动对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层次线性模型将用于评估纵向效应、相互作用和协变量中介。

DESCRIPTION (provided by applicant): Background: Preliminary evidence suggests that meditation and exercise may work through interacting psychological and physiological pathways to stimulate the immune system and reduce infectious disease. Methods: In this study, women and men aged 50 and older will be randomized to: 1) an 8 week behavioral training program in mindfulness meditation, 2) an intensity, duration and location-matched 8 week exercise training program, or 3) a health education session attention control group. Sample size will be N=333, with N=111 in each group. The primary outcome will be severity-adjusted total days of acute respiratory infection (ARI) illness during 8 months of observation, as self-reported on the Wisconsin Upper Respiratory Symptom Survey, a validated questionnaire outcome measure. Nucleic acid based viral identification will verify infection. Nasal wash during ARI illness will be analyzed for inflammatory markers IL-8 and nasal neutrophil count. Secondary outcome immune biomarkers will include antibody response to influenza immunization (serum IgG, mucosal IgA) and cytokines IFN-? and IL-10 from cultured ex vivo lymphocytes. Questionnaire measures assessing perceived stress, positive and negative affectivity, optimism and anxiety will be analyzed as potential mediators of immunomodulation. Timeframe / logistics: This will be a 4 year project, with 3 annual cohorts (1st year N=75; 2nd and 3rd years N=129 each). Yearly cohorts will be screened from January to August, undergo a short adherence-assessing run-in trial in September, then consent and be randomized to meditation, exercise or control starting in October. Tri-valent influenza vaccination will occur in November on week 6 of behavioral sessions. Blood for antibody titer and ex vivo cytokine assay will be drawn at baseline, at the end of the 8 week session, and once again 3 months later. Nasal swab for IgA will be done at the same time. Participants will be followed with telephone contact every two weeks, with monthly questionnaire instruments, and with daily self-assessments during ARI illness episodes. Analysis: ANOVA-based models assess effects of meditation and exercise on immune markers and ARI illness. Psychological 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 REVELANCE: The overarching goal of this project is to determine whether mind-body practices such as meditation or exercise can reduce the public health burden of acute respiratory infection. A major secondary goal is to determine whether mindfulness meditation or moderately strenuous exercise can enhance immune processes such as antibody response to influenza vaccination (flu shots). Finally, we want to investigate the influence of stress, optimism, anxiety and positive and negative emotion on immunity and resistance to respiratory infection.