Tai Chi Chih and Varicella Zoster Immunity
|First Received Date ICMJE||January 11, 2002|
|Last Updated Date||August 17, 2006|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00029484 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Tai Chi Chih and Varicella Zoster Immunity|
|Official Title ICMJE||Tai Chi Chih and Varicella Zoster Immunity|
A randomized control trial testing whether a relaxation response based intervention, Tai Chi Chih, will affect Varicella Zoster Virus (VZV) specific immunity measures of psychological adaptation and health function in the older adult.
Both the incidence and severity of Herpes Zoster (HZ) or "Shingles" increase markedly with increasing age, is a painful condition, due to a decline in Varicella Zoster Virus (VZV) specific immunity. Considerable evidence further shows that psychological stresses salient in the older adult correlate with impairments of cellular immunity.
The investigators have observed that Varicella Zoster Immunity is always decreased in individuals with major depression. Moreover, our preliminary data indicates that the presence of depressive symptoms in older adults is associated with a decline of VZV responder cell frequency (VZV-RCF). Taken together, the untoward effects of age and depressive symptoms on VZV immunity raise the question as to whether an alternative medicine intervention might augment VZV specific immunity in the older adult. We have preliminarily 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 controls. TCC is a slow moving meditation comprised of twenty separate standardized movements for use in elderly populations.
This proposed controlled clinical trial aims to: 1) determine whether the practice of TCC for 16 weeks influences Varicella Zoster Virus (VZV) immunity; 2) demonstrate that TCC can produce significant changes in psychological adaptation, health behaviors, and health functioning and well-being; and 3) assess whether changes in psychological adaptation, health behaviors, and health functioning correlate with changes in VZV immunity following TCC in older adults.
We hypothesize that this behavioral intervention that prioritizes treatment of excessive physiological arousal can influence one's affective state with effects on cellular immunity. By standardization of training and practice schedules, TCC offers an important advantage over prior relaxation response based therapies. Focus on older adults at increase risk for HZ and assay of VZV specific cellular immunity has implications for understanding the impact of behavioral factors and an alternative medicine intervention on a clinically relevant endpoint and the ability of the immune system to respond to antigens of infectious pathogens.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized|
|Intervention ICMJE||Behavioral: Tai chi chih|
|Study Arm (s)||Not Provided|
|Publications *||Michael R. Irwin, MD, Jennifer L. Pike, PhD, Jason C. Cole, PhD, and Michael N. Oxman, MD. Effects of a Behavorial Intervention, Tai Chi Chih, on Varicella-Zoster Virus Specific Immunity and Health Functioning in Older Adults. Psychosomatic Medicine 65:824-830, 2003|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
History of Varicella or long-term resident (greater than or equal to 30 years) in the continental United States.
|Ages||60 Years to 80 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00029484|
|Other Study ID Numbers ICMJE||R21 AT000255-01|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Center for Complementary and Alternative Medicine (NCCAM)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Center for Complementary and Alternative Medicine (NCCAM)|
|Verification Date||July 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP