University of Wisconsin Meditation & Exercise Cold Study (MEPARI-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Wisconsin, Madison
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01654289
First received: July 19, 2012
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Acute Respiratory Infection
Other: Mindfulness Meditation
Other: Exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Meditation or Exercise for Preventing Acute Respiratory Infection (MEPARI-2)

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Severity-weighted total days of ARI illness [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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). 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.


Secondary Outcome Measures:
  • Absenteeism [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Employment, including type of work, hours per week worked, and compensation, assessed as hourly wage, will be assessed at enrollment. Each week throughout the study participants will complete questions to assess number of hours of work missed. Study personnel blinded to allocation group status will assess and classify reasons for missed work as either ARI-related or not ARI-related.

  • Health Care Utilization [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Total number of health care visits, ARI-related health care visits, and ARI-related prescriptions, including antibiotics and anti-influenza anti-virals will be documented. Each weekly communication will include the question, "Have you seen a doctor or visited a clinic, hospital or urgent care center?" Persons answering "Yes" will be asked the reason for the visit. Those answers will then be classified by blinded study personnel as either "Related," or "Unrelated" to ARI illness, including upper respiratory infection, influenza, pharyngitis, acute sinusitis, bronchitis, and pneumonia.

  • SF-12 [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Also known as the Medical Outcomes Study Short Form, this 12-item questionnaire is commonly used to measure overall health, including physical (SF12-P) and mental health (SF12-M) subscales. It has been extensively assessed for reliability, responsiveness and criterion validity. In this study, it will be used to assess potential changes in general physical and mental health due to interventions, and as a covariate to control for baseline between-person differences in multivariate efficacy analyses.

  • Perceived Stress Scale (PSS-10) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    The PSS-10 has been validated in multiple studies. PSS scores predict rates of viral infection among volunteers inoculated with rhinovirus, and correlate with physiologic and self-report indicators of ARI illness, including nasal IL-6 level. Because stress reduction is one of the hypothesized mechanisms of action, this study population will include working-age participants, who are presumed to be more stressed.

  • Mindfulness-based Self Efficacy Scale (MSES) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Research aimed at defining and assessing the concept of "mindfulness" is well underway, with several questionnaire instruments available. The MSES is one of the more recent questionnaires, developed by Cayoun and Freestun to assess effects of MBSR training on perceived self-efficacy. The MSES assesses 7 domains related to mindfulness self-efficacy, including behavior, cognition, interoception, affect, interpersonal, avoidance and mindfulness. The MSES will provide a nice counterpart to the ESES to help distinguish effects of interventions on ARI outcomes.

  • Exercise Self-Efficacy Scale (ESES) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Self-efficacy has been defined as "the belief in one's capabilities to organize and execute the courses of action required to manage prospective situations." The ESES scale was developed based on work by Bandura and colleagues,and has been validated by Shin, Kroll,and Everett. For this study, the ESES will be used to verify results of the exercise intervention, and to help explain potential mediational effects of exercise.

  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Sleep quality has been linked to several important quality of life and health outcomes. The PSQI is widely used and has been assessed for reliability and validity.In this study, improved sleep is a potential mediator of intervention effects, and a potentially important outcome on its own.

  • Body Mass Index (BMI) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Body habitus is associated with many disease processes, and may be related to immune function and susceptibility to respiratory infection. Height will be assessed at baseline only. Weight will be measured at baseline, 1 and 4 months post-intervention, and at exit. Baseline BMI will be calculated and used as a covariate in statistical models. BMI will also be considered a secondary outcome of potential importance.

  • Blood Pressure [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Standard brachial blood pressure will be assessed by trained nurses using calibrated sphygmomanometers.

  • Pro-Inflammatory Cytokines [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Laboratory-assessed objective measures will primarily serve to corroborate self-reports of disease severity. High sensitivity C-reactive protein (HS-CRP) is a well-established indicator of disease severity during respiratory infection, and can be measured in serum and in nasal wash.Concentrations of interleukin-6 (IL-6)and interleukin-8 (IL-8)in nasal wash have been shown to correlate with illness severity. More recently, interferon-gamma-induced protein 10 (IP-10) has been shown to be measurably increased in both serum and nasal wash during times of acute viral ARI.


Estimated Enrollment: 396
Study Start Date: June 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness Meditation
Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Other: Mindfulness Meditation
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.
Other Name: MBSR
Experimental: Exercise
The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Other: Exercise
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.
Other Name: physical activity
No Intervention: Wait-list control
Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654289

Contacts
Contact: Shari Barlow 608-333-2653 shari.barlow@fammed.wisc.edu
Contact: Mary Checovich 608-622-9891 mary.checovich@fammed.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Department of Family Medicine Recruiting
Madison, Wisconsin, United States, 53715
Contact: Shari Barlow    608-333-2653    shari.barlow@fammed.wisc.edu   
Contact: Mary Checovich    608-622-9891    mary.checovich@fammed.wisc.edu   
Principal Investigator: Bruce Barrett, MD PhD         
Sub-Investigator: Mary Hayney, PharmD         
Sub-Investigator: Christopher Coe, PhD         
Sub-Investigator: Daniel Muller, MD PhD         
Sub-Investigator: David Rakel, MD         
Sub-Investigator: Roger Brown, PhD         
Sub-Investigator: Aleksandra Zgierska, MD PhD         
Sub-Investigator: Zhengjun Zhang, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Bruce Barrett, MD PhD University of Wisconsin Department of Family Medicine
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01654289     History of Changes
Other Study ID Numbers: 2012-0207, R01AT006970
Study First Received: July 19, 2012
Last Updated: September 10, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by University of Wisconsin, Madison:
respiratory tract infections
common cold
exercise
influenza
meditation

Additional relevant MeSH terms:
Communicable Diseases
Infection
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 29, 2014