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

描述（由申请人提供）：初步证据表明，为期8周的冥想和运动训练计划可以减少急性呼吸道感染（ARI）疾病的发病率、持续时间和严重程度。在这个平行的三组试验中，年龄在30到69岁之间的男女将被随机分配到：1)一个为期8周的正念冥想行为训练项目，2)一个强度、持续时间和地点匹配的8周锻炼项目，或3)一个等待名单观察对照组。招募对象将是那些不经常锻炼、没有接受过冥想训练、压力水平等于或高于平均水平的人。主要结局将是严重程度加权的急性呼吸道感染总天数，通过自我报告在经过验证的威斯康星州上呼吸道症状调查（wwurss -24）中进行评估。每周一次的ARI疾病计算机辅助电话监测将由对干预组不知情的人员操作。对于每次急性呼吸道感染，将对鼻腔样本进行多重PCR（聚合酶链反应）检测以确定病毒，并分析中性粒细胞计数、白细胞介素-6和白细胞介素-8浓度。将记录与急性呼吸道感染相关的卫生保健设施就诊情况以及从工作和学习中损失的时间，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、社会支持、睡眠质量和一般身心健康的问卷测量将被分析为导致行为训练干预到ARI疾病结局的因果途径的潜在中介。这将是一个为期5年的项目，每年有4个队列，每个队列n=99，随机分为3组，每组n=33。假设随访损失9%，则最终样本量为n=360名研究参与者，每个对照组n=120名。登记、随机化和研究干预将于9月开始。参与者将通过每周自我报告进行监测，直至5月。萨默斯将负责数据清理、初步分析和招募明年的新员工。零膨胀多元回归模型将评估冥想和运动对急性呼吸道感染疾病、医疗保健利用和旷工的影响。将评估心理社会措施作为冥想和运动对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): 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.