Meditation and Exercise for Prevention of Acute Respiratory Infection (MEPARI)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01057771
First received: January 22, 2010
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Acute Respiratory Infection
Behavioral: Meditation
Behavioral: Exercise
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Meditation and Exercise for Prevention of Acute Respiratory Infection

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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. [ Time Frame: 2009-2010 cold season ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 3 weeks after flu shot ] [ Designated as safety issue: No ]
  • Severity of illness assessed by biomarkers from nasal wash (IL-8, neurophil count) [ Time Frame: every cold or flu illness illness episode ] [ Designated as safety issue: No ]
  • Nucleic acid based viral identification will identify pathogen and verify all symptomatic infections [ Time Frame: every cold or flu illness episode ] [ Designated as safety issue: No ]

Enrollment: 154
Study Start Date: June 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meditation
Eight weeks of training in mindfulless meditation. Weekly group sessions of 2.5 hours, with 45 minutes/day of practice.
Behavioral: Meditation
Eight weeks of training in mindfulless meditation. Weekly group sessions of 2.5 hours, with 45 minutes/day of practice.
Experimental: Exercise
Eight weeks of training in moderately strenuous exercise. Weekly group sessions of 2.5 hours, with 45 minutes/day of practice.
Behavioral: Exercise
Eight weeks of training in moderately strenuous exercise. Weekly group sessions of 2.5 hours, with 45 minutes/day of practice.
No Intervention: Waiting list control
Waiting list control subjects will be treated exactly like those in active intervention groups, but will not receive interventions.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: 1) 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.

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Exclusion Criteria: 1) 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.

  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: NCT01057771

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Bruce Barrett, MD, PhD University of Wisconsin Department of Family Medicine
  More Information

Publications:

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01057771     History of Changes
Other Study ID Numbers: 2009-0075, R01AT004313
Study First Received: January 22, 2010
Last Updated: May 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
meditation
exercise
immunity
respiratory infection
influenza
flu shot
immunomodulation

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

ClinicalTrials.gov processed this record on July 20, 2014