University of Wisconsin Meditation & Exercise Cold Study
Condition: Acute Respiratory Infection
MeSH terms: Infections; Respiratory Tract Infections
Intervention: Mindfulness Meditation; Exercise
Intervention description: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.; Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 413.0
Sex: All
Minimum age: 30 Years
Maximum age: 69 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: respiratory tract infections; common cold; exercise; influenza; meditation

Summary:

      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:

        1. 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.

        2. 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.

        3. 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).

        4. Compare the potential benefits of mindfulness meditation to those from moderate
           intensity sustained exercise.

        5. 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.