Meditation and Exercise for Prevention of Acute Respiratory Infection

NCT01057771 | Completed Phase 2 DMC

• 2 other identifiers: 2009-0075R01AT004313
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Infection

Keywords

meditation; exercise; immunity; respiratory infection; influenza; flu shot; immunomodulation

Outcome Measures

Primary Outcomes (1)

• 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.

  2009-2010 cold season

Secondary Outcomes (3)

• 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

Study Arms (3)

Meditation

EXPERIMENTAL

Eight weeks of training in mindfulless meditation. Weekly group sessions of 2.5 hours, with 45 minutes/day of practice.

Behavioral: Meditation

Exercise

EXPERIMENTAL

Eight weeks of training in moderately strenuous exercise. Weekly group sessions of 2.5 hours, with 45 minutes/day of practice.

Behavioral: Exercise

Waiting list control

NO INTERVENTION

Waiting list control subjects will be treated exactly like those in active intervention groups, but will not receive interventions.

Interventions

Meditation BEHAVIORAL

Eight weeks of training in mindfulless meditation. Weekly group sessions of 2.5 hours, with 45 minutes/day of practice.

Meditation

Exercise BEHAVIORAL

Eight weeks of training in moderately strenuous exercise. Weekly group sessions of 2.5 hours, with 45 minutes/day of practice.

Exercise

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

Related Publications (5)

• Barrett B, Hayney MS, Muller D, Rakel D, Ward A, Obasi CN, Brown R, Zhang Z, Zgierska A, Gern J, West R, Ewers T, Barlow S, Gassman M, Coe CL. Meditation or exercise for preventing acute respiratory infection: a randomized controlled trial. Ann Fam Med. 2012 Jul-Aug;10(4):337-46. doi: 10.1370/afm.1376.

  PMID: 22778122 RESULT

• Zgierska A, Obasi CN, Brown R, Ewers T, Muller D, Gassman M, Barlow S, Barrett B. Randomized controlled trial of mindfulness meditation and exercise for the prevention of acute respiratory infection: possible mechanisms of action. Evid Based Complement Alternat Med. 2013;2013:952716. doi: 10.1155/2013/952716. Epub 2013 Sep 29.

  PMID: 24191174 RESULT

• Obasi CN, Brown R, Ewers T, Barlow S, Gassman M, Zgierska A, Coe CL, Barrett B. Advantage of meditation over exercise in reducing cold and flu illness is related to improved function and quality of life. Influenza Other Respir Viruses. 2013 Nov;7(6):938-44. doi: 10.1111/irv.12053. Epub 2012 Nov 21.

  PMID: 23170828 RESULT

• Hayney MS, Coe CL, Muller D, Obasi CN, Backonja U, Ewers T, Barrett B. Age and psychological influences on immune responses to trivalent inactivated influenza vaccine in the meditation or exercise for preventing acute respiratory infection (MEPARI) trial. Hum Vaccin Immunother. 2014;10(1):83-91. doi: 10.4161/hv.26661. Epub 2013 Oct 7.

  PMID: 24096366 RESULT

• Rakel D, Mundt M, Ewers T, Fortney L, Zgierska A, Gassman M, Barrett B. Value associated with mindfulness meditation and moderate exercise intervention in acute respiratory infection: the MEPARI Study. Fam Pract. 2013 Aug;30(4):390-7. doi: 10.1093/fampra/cmt008. Epub 2013 Mar 20.

  PMID: 23515373 RESULT

MeSH Terms

Conditions

Motor Activity; Respiratory Tract Infections; Influenza, Human

Interventions

Meditation; Exercise

Condition Hierarchy (Ancestors)

Behavior; Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bruce Barrett, MD, PhD

  University of Wisconsin Department of Family Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 27, 2010
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

US (1)