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Completed

NCT Number: NCT00118885

Shingles: Immune Effects of Tai Chi

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.

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Key information

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai Chi Chih

Behavioral

Primary outcomes

  1. varicella zoster specific immunity

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

National Institute on Aging (NIA)

Nih

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Behavioral Intervention for Herpes Zoster Risk in Aging

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Jul 12, 2005
Registry last updated
Dec 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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