Meditation or Exercise for Preventing Acute Respiratory Infection (MEPARI-2)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 413
- 试验地点
- 2
- 主要终点
- Severity-weighted Total Days of ARI Illness
研究概览
简要总结
The primary goal of this project is to determine whether behavioral training in mindfulness meditation or moderate intensity sustained exercise will lead to reductions in acute respiratory infection (ARI) illness, such as common cold and influenza like illness. Specifically, this project aims to:
- Determine whether an 8-week training program in mindfulness meditation, as compared to the control group, will lead to significant reductions in incidence, duration, and severity of ARI illness.
- Determine whether an 8-week training program in moderate intensity sustained exercise, as compared to the control group, will lead to reductions in incidence, duration, and severity of ARI illness.
- Assess whether any observed reductions in ARI illness are accompanied by fewer ARI-related health care visits and less time lost to productive work (reduced absenteeism).
- Compare the potential benefits of mindfulness meditation to those from moderate intensity sustained exercise.
- Discern potential mediating factors and causal pathways that might help explain how these interventions lead to improved ARI illness-related outcomes.
The investigators' 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.
详细描述
Acute respiratory infection (ARI), including common cold and influenza, is a leading cause of morbidity and mortality, and has a major economic impact. Both mental and physical health are linked to ARI burden. For example, people who report more negative emotion and higher stress are more likely to get ARI. Exercise affects the immune system, improves physical and mental health, and may protect against ARI illness. Mindfulness meditation reduces perceived stress, influences the immune system, and may protect against ARI. The investigators' own recent NCCAM-funded trial randomized 154 people to 3 groups: 1) meditation, 2) moderate intensity exercise, or 3) wait-list control. For the 149 people followed to study completion, there were 40 ARI episodes and 453 days of illness in the control group, 27 episodes and 257 days of ARI illness in the meditation group, and 26 episodes and 241 days of ARI illness in the exercise group. Corresponding reductions in ARI-related work days lost to ARI illness were observed. The proposed research will build upon these findings with refined methodology in a larger sample to: A) determine whether these findings are replicable, and B) investigate potential explanatory pathways.
This research will use state-of-the-art randomized controlled trial (RCT) methodology to assess potential effects of meditation or exercise on ARI 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. Participants will be randomized to 1 of 3 groups: 1) an 8-week training program in mindfulness meditation, 2) an attention, duration and location-matched program in progressive exercise, or 3) a non-interventional wait-list control group. Each cohort will be observed for 8 months comprising the annual cold and flu season. Enrollment, randomization and study interventions will begin in September of each year. 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.
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 like illness. The primary outcome will be severity-weighted total days of ARI illness (global severity), calculated as trapezoidal approximation to area under the time severity curve during ARI illness, with severity assessed once daily using self-reports on the validated Wisconsin Upper Respiratory Symptom Survey (WURSS-24).
Computer-assisted weekly monitoring will assure that ARI illness episodes are detected, and will serve to document secondary outcomes, including health care utilization and work or school absenteeism. Visits to health care facilities and time lost from work and school will be documented, then classified as ARI-related (or not) by personnel blinded to allocation. Questionnaire measures assessing perceived stress, self-efficacy, sleep quality, depression, and general mental and physical health will also be analyzed as secondary outcomes. Degree of stress reduction, mindfulness, positive and negative emotion, social support, self-efficacy and sleep quality will be analyzed as potential mediators of effects of interventions on outcomes.
Laboratory assessed objective measures will primarily serve to corroborate self-reports of disease severity, but will also be analyzed as potential mediators of effects of behavioral interventions on ARI illness incidence, duration, and severity. As potential mediators, pro-inflammatory cytokines (CRP, IL-6, IL-8, IP-10) will be assessed as change from baseline to one month after the 8 week behavioral interventions finish. These will serve as indicators of a pro-inflammatory state. Repeating these assays 3 months later will assess whether pro-inflammatory changes from baseline will be sustained. Cytokines from samples taken during ARI illness will be assessed as corroborating biomarkers of disease severity. Identification of viral agents using multiplex PCR will also serve to corroborate ARI self-reports.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 30-69 years at study entry.
- •Must answer "Yes" to either "Have you had at least 2 colds in the last 12 months?" and/or "On average do you get at least 1 cold per year?"
- •Prospective participants must meet the American Heart Association guidelines for suitability for an exercise program. Prospective participants will be advised (but not required) to seek their physicians' advice before enrollment.
- •Self-reported ability and willingness to follow through with either exercise or meditation training, or neither, according to randomized allocation, and to participate in blood draws, nasal wash, self-report questionnaires, and weekly monitoring for 9 months.
- •A score of 14 or lower on the PHQ-9 depression screen, self-reported both at entrance to run-in trial and again just prior to enrollment in the main study.
- •Fluency and literacy in English language sufficient for understanding the study protocol and completing questionnaires.
- •Successful completion of tasks during run-in period, including 2 in-person appointments, 1 phone contact, 1 set of homework questionnaires, and baseline nasal wash and blood draw.
排除标准
- •Current or recent use of meditative practice, or previous meditation training. Assessed by answering "Yes" to any of the following questions: Do you meditate on a regular basis? In the last year, have you meditated at least weekly for 2 or more months in a row? Have you ever been trained in meditation? Have you ever been involved in a mindfulness class or mindfulness practice?
- •Potential participants must not engage in moderate exercise more than twice per week or vigorous exercise more than once per week, as assessed by the following questions adapted from the Behavioral Risk Factor Surveillance System (BRFSS) classification system: On average, how many times per week do you engage in moderate recreational activities such as walking, tennis doubles, ballroom dancing, weight training, or similar activities that last at least 20 minutes per occasion? A) Less than 1 time per week; B) 1 time per week; C) 2 times per week; D) 3 times per week; E) >4 times per week. How many times per week do you engage in vigorous sport and recreational activities such as jogging, swimming, cycling, singles tennis, aerobic dance or other similar activities lasting at least 20 minutes per occasion? A) Less than 1 time per week; B) 1 time per week; C) 2 times per week; D) 3 or more times per week.
- •Women who are pregnant at screening or plan to become pregnant during the course of the study (determined by self-report) will be excluded. Women who become pregnant any time during the course of the trial will not be dropped and will continue to be followed throughout the duration of the study.
- •Physical, medical or mental condition(s) precluding adherence to study protocol. Conditions include: malignant disease (prospective participants' physicians to advise and Dr. Barrett, and/or designee Dr. Rakel or Dr. Muller, to make final decision); and function-impairing psychopathology (prospective participants' psychiatrist or psychologist to advise). Questionable cases will be reviewed by the study physicians.
- •True contraindication for influenza vaccine (flu shots) or refusal to accept influenza vaccine. Subjects will be asked to verify they have a) no known egg allergy, b) no prior reaction to influenza vaccine, and c) never been told they have Guillain-Barre Syndrome.
- •Current use or forecasted need for immunoactive drugs (eg. steroids, immunosuppressants, chemotherapy); nonsteroidal antiinflammatories will be allowed.
- •Immune deficiency or auto-immune disease (eg. HIV/AIDS, lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease). Questionable cases will be reviewed by study physicians.
结局指标
主要结局
Severity-weighted Total Days of ARI Illness
时间窗: 8 months
The primary outcome will be severity-weighted total cumulative days of ARI illness (global severity), calculated as trapezoidal approximation to area under the time severity curve during ARI illness, with severity assessed once daily using self-reports on the validated Wisconsin Upper Respiratory Symptom Survey (WURSS-24). Incidence (number of ARI episodes in each group) and duration (total number of days of ARI illness) are components of the primary outcome, and will be analyzed separately.
次要结局
- Absenteeism(8 months)
- Mindfulness-based Self Efficacy Scale (MSES)(8 months (exit from study))
- SF-12(Baseline and 8 months (exit from study))
- Pittsburgh Sleep Quality Index (PSQI)(Baseline and 8 months (exit from study))
- Health Care Utilization(8 months)
- Pro-Inflammatory Cytokines(Baseline, 4 months post-intervention (December) and 8 months post-intervention (March).)
- Perceived Stress Scale (PSS-10)(Baseline and 8 months (exit from study))
- Exercise Self-Efficacy Scale (ESES)(Baseline and 8 months (exit from study))
- Body Mass Index (BMI)(Baseline and 8 months (exit from study))
- Blood Pressure(Baseline and 8 months (exit from study))