Shingles: Immune Effects of Tai Chi
Behavioral Intervention for Herpes Zoster Risk in Aging
2 other identifiers
interventional
140
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2001
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 8, 2005
CompletedFirst Posted
Study publicly available on registry
July 12, 2005
CompletedDecember 11, 2009
November 1, 2006
3.4 years
July 8, 2005
December 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
varicella zoster specific immunity
Secondary Outcomes (1)
measures of health status including SF-36 scores, depressive symptoms, and health behaviors
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
Los Angeles, California, 90095, United States
Related Publications (6)
Miller GE, Cohen S. Psychological interventions and the immune system: a meta-analytic review and critique. Health Psychol. 2001 Jan;20(1):47-63. doi: 10.1037//0278-6133.20.1.47.
PMID: 11199066BACKGROUNDOxman 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. doi: 10.1056/NEJMoa051016.
PMID: 15930418BACKGROUNDIrwin 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. doi: 10.1093/ecam/neh048. Epub 2004 Dec 1.
PMID: 15841255BACKGROUNDIrwin 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. doi: 10.1097/01.psy.0000088591.86103.8f.
PMID: 14508027BACKGROUNDIrwin 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.
PMID: 21934474DERIVEDIrwin MR, Olmstead R, Motivala SJ. Improving sleep quality in older adults with moderate sleep complaints: A randomized controlled trial of Tai Chi Chih. Sleep. 2008 Jul;31(7):1001-8.
PMID: 18652095DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael R. Irwin, MD
Norman Cousins Professor, Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
July 8, 2005
First Posted
July 12, 2005
Study Start
July 1, 2001
Primary Completion
December 1, 2004
Study Completion
December 1, 2004
Last Updated
December 11, 2009
Record last verified: 2006-11