Meditation and Exercise for Prevention of Acute Respiratory Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Severity-adjusted total days of acute respiratory infection (ARI) illness, as self-reported on the Wisconsin Upper Respiratory Symptom Survey (WURSS-24). Incidence (number) of cold flu episodes and total unadjusted days of illness will also be reported.
研究概览
简要总结
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.
详细描述
ABSTRACT
Background Preliminary evidence suggests that meditation and exercise may work through interacting psychological and physiological pathways to influence the immune system and reduce infectious respiratory 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 waiting list control group. Sample size will be N=150 enrolled, with N=50 in each group. The main patient-oriented outcome will be severity-adjusted total days of acute respiratory infection (ARI) illness, as self-reported on the Wisconsin Upper Respiratory Symptom Survey (WURSS-24), a validated questionnaire outcome measure. Nucleic acid based viral identification will verify all symptomatic infections, and the cytokine IL-8 and nasal neutrophil from nasal wash will serve as biomarkers of illness severity. Biomarkers of immune function will include antibody response to influenza immunization (serum IgG, mucosal IgA) and cytokines IFN-γ and IL-10 from cultured ex vivo lymphocytes. Questionnaire measures assessing perceived stress, positive and negative emotion, optimism, and anxiety will be analyzed as potential mediators of immunomodulation and illness prevention.
Timeframe / logistics This will be a 2-year project, with 2 cohorts conducted during a single cold season. The first cohort of N=60 will be randomized and begin interventions in September 2009. The second cohort of N=90 will be randomized and begin interventions in January 2010. Tri-valent influenza vaccination will occur on week 6 of behavioral interventions in both cohorts. 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 times. Participants will be followed with telephone contact every 2 weeks, with monthly questionnaire instruments, and with daily self-assessments during ARI illness episodes.
Analysis ANOVA-based models will 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.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 50 years or older at study entry. 2) Literacy in English language sufficient for understanding the study protocol and completing questionnaires. 3) 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?" 4) Self-reported ability and willingness to follow through with either exercise or meditation training, or neither, according to randomized allocation. 5) Successful completion of tasks during run-in period, including 2 in-person appointments, 2 phone contacts, and 1 set of homework questionnaires. 6) 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. 7) A score of 24 points or higher on the Folstein mini-mental status exam, administered by research personnel at entrance to run-in trial and again just prior to consent and enrollment in the main study.
排除标准
- •Physical or medical condition prohibiting adherence to study protocol. Prospective participants must meet the American Heart Association guidelines225 for suitability for an exercise program. Prospective participants will be advised (but not required) to seek their physicians' advice before enrollment. 2) 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? 3) 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 BRFSS classification226 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. 4) Immune deficiency or auto-immune disease (eg. HIV/AIDS, lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease; Co-Investigator Dr. Muller will advise in questionable cases). 5) Current use or forecasted need for immunoactive drugs (eg. steroids, immunosuppressants, chemotherapy); nonsteroidal antiinflammatories will be allowed. 6) Current use or forecasted need for antibiotic or antiviral medications (eg. prophylactic or suppressive therapy for chronic urinary tract infection, recurrent herpes, or other chronic infections. 7) Malignant disease (prospective participants' physicians to advise. Dr. Barrett to make final decision in questionable cases). 8) Function-impairing psychopathology (prospective participants' psychiatrist or psychologist to advise). 9) Influenza vaccination (flu shots) within 6 months prior to enrollment. 10) True egg allergy or true allergic reaction to prior flu shot, either of which would have to include at least one of the following: a) large rash or swelling (more than 12 inches in diameter), b) any swelling in throat, c) any difficulty breathing, d) reaction with hospitalization, or e) anaphylaxis. Reactions that would NOT exclude people: a) local pain or swelling, b) fever, c) malaise, feeling lousy, or d) cold, flu or other infectious illness.
结局指标
主要结局
Severity-adjusted total days of acute respiratory infection (ARI) illness, as self-reported on the Wisconsin Upper Respiratory Symptom Survey (WURSS-24). Incidence (number) of cold flu episodes and total unadjusted days of illness will also be reported.
时间窗: 2009-2010 cold season
次要结局
- Immune response to influenza immunization (flu shot): serum IgG, mucosal IgA, and cytokines IFN-γ and IL-10 from cultured ex vivo lymphocytes. Flu shots are given in 6th week of 8 week intervention sessions.(3 weeks after flu shot)
- Severity of illness assessed by biomarkers from nasal wash (IL-8, neurophil count)(every cold or flu illness illness episode)
- Nucleic acid based viral identification will identify pathogen and verify all symptomatic infections(every cold or flu illness episode)