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Shingles: Immune Effects of Tai Chi

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00118885
First received: July 8, 2005
Last updated: December 9, 2009
Last verified: November 2006
  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:


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:

  1. 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;
  2. demonstrate that TCC can produce significant changes in psychological adaptation, health behaviors, and health functioning and well-being;
  3. 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
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: NCT00118885

Locations
United States, California
Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Investigators
Principal Investigator: Michael R. Irwin, MD Norman Cousins Professor, Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014