University of Wisconsin Meditation & Exercise Cold Study

Completed · Phase 2

Conditions studied: Acute Respiratory Infection

In brief

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.

Key facts

Study ID: NCT01654289
Run by: University of Wisconsin, Madison
People needed: 413
Starts: 2012-07-01
Expected to finish: 2016-06-01
Last updated by the study team: 2018-11-07

Who can join

Age: 30 and older, up to 69. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Wisconsin Department of Family Medicine — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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