Shingles: Immune Effects of Tai Chi - Full Text View

Purpose

The purpose of this trial is to evaluate the effects of Tai Chi Chih versus Health Education on shingles immunity in older adults as measured by unstimulated and vaccine-stimulated responses. The secondary goal of the study is to determine the effects of Tai Chi Chih versus Health Education on measures of health functioning, depressive symptoms, and health behaviors in the elderly.

Condition	Intervention	Phase
Aging Herpes Zoster	Behavioral: Tai Chi Chih	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment
Official Title:	Behavioral Intervention for Herpes Zoster Risk in Aging

Resource links provided by NLM:

MedlinePlus related topics: Chickenpox Healthy Living Shingles

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

varicella zoster specific immunity

Secondary Outcome Measures:

measures of health status including SF-36 scores, depressive symptoms, and health behaviors

Estimated Enrollment:	140
Study Start Date:	July 2001
Study Completion Date:	December 2004
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Detailed Description:

Shingles, also known as herpes zoster (HZ), is more common in older persons due to the weakening of the immune system with advancing age. Psychosocial stresses in the older adult also correlate with the decline in immunity. In addition, preliminary data indicate that the presence of depressive symptoms in older adults is associated with a decline in the response to varicella zoster virus (VZV) vaccination. Taken together, the untoward effects of age and depressive symptoms on VZV immunity raise the question as to whether a behavioral intervention might augment VZV specific immunity in the older adult.

Preliminary data has shown that administration of a relaxation-response based intervention, Tai Chi Chih (TCC), results in improvements in health functioning and VZV immunity in older adults as compared to a control group. TCC is a slow moving meditation comprised of twenty separate standardized movements for use in elderly populations. By standardization of training and practice schedules, TCC offers an important advantage over prior relaxation response based therapies. This controlled trial has 3 goals:

determine whether the practice of TCC for 16 weeks influences unstimulated- and vaccine-stimulated VZV specific immunity in adults 60 years of age and older;
demonstrate that TCC can produce significant changes in psychological adaptation, health behaviors, and health functioning and well-being;
assess whether changes in psychological adaptation, health behaviors, and health functioning correlate with changes in VZV immunity following TCC in older adults.

Eligibility

Ages Eligible for Study:	60 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Older than 60 years of age at time of entry
History of varicella or long term (>30 years) residence in the continental USA
Accessible geographically

Exclusion Criteria:

Immunosuppression resulting from neoplastic disease, corticosteroids or other therapy
Significant underlying illness that would be expected to prevent completion of the study; any other condition (e.g. extensive psoriasis, chronic pain syndrome, cognitive impairment, severe hearing loss) that in the opinion of the investigator might interfere with the required evaluations
Not ambulatory (bed-ridden)
Prior HZ or prior receipt of varicella vaccine
Allergic sensitivity to neomycin
Receipt of immune globulin or other blood product within 3 months before the study period
Receipt of other immunizations (e.g., hepatitis B vaccine) within 1 month of immunization
Women who are not post-menopausal
Acutely depressed or a suicidal risk
Unable to commit to intervention schedule
No history of varicella or varicella vaccination or no evidence of VZV immunity
Contact with immunosuppressed individuals or pregnant women who do not have a history of chickenpox
Active infections such as tuberculosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118885

Locations

United States, California
Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
Los Angeles, California, United States, 90095

Sponsors and Collaborators

National Institute on Aging (NIA)

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Michael R. Irwin, MD

Norman Cousins Professor, Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute

More Information

Publications:

Miller GE, Cohen S. Psychological interventions and the immune system: a meta-analytic review and critique. Health Psychol. 2001 Jan;20(1):47-63.

Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, Arbeit RD, Simberkoff MS, Gershon AA, Davis LE, Weinberg A, Boardman KD, Williams HM, Zhang JH, Peduzzi PN, Beisel CE, Morrison VA, Guatelli JC, Brooks PA, Kauffman CA, Pachucki CT, Neuzil KM, Betts RF, Wright PF, Griffin MR, Brunell P, Soto NE, Marques AR, Keay SK, Goodman RP, Cotton DJ, Gnann JW Jr, Loutit J, Holodniy M, Keitel WA, Crawford GE, Yeh SS, Lobo Z, Toney JF, Greenberg RN, Keller PM, Harbecke R, Hayward AR, Irwin MR, Kyriakides TC, Chan CY, Chan IS, Wang WW, Annunziato PW, Silber JL; Shingles Prevention Study Group. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med. 2005 Jun 2;352(22):2271-84.

Irwin M, Pike J, Oxman M. Shingles Immunity and Health Functioning in the Elderly: Tai Chi Chih as a Behavioral Treatment. Evid Based Complement Alternat Med. 2004 Dec;1(3):223-232. Epub 2004 Dec 1.

Irwin MR, Pike JL, Cole JC, Oxman MN. Effects of a behavioral intervention, Tai Chi Chih, on varicella-zoster virus specific immunity and health functioning in older adults. Psychosom Med. 2003 Sep-Oct;65(5):824-30.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Irwin MR, Olmstead R. Mitigating cellular inflammation in older adults: a randomized controlled trial of Tai Chi Chih. Am J Geriatr Psychiatry. 2012 Sep;20(9):764-72. doi: 10.1097/JGP.0b013e3182330fd3.

ClinicalTrials.gov Identifier:	NCT00118885 History of Changes
Other Study ID Numbers:	AG0029, R01AG18367
Study First Received:	July 8, 2005
Last Updated:	December 9, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

Shingles
depression
varicella zoster virus
alternative medicine
psychoneuroimmunology

Additional relevant MeSH terms:

Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013