Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
140 participants
INTERVENTIONAL
2001-07-31
2004-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
Interventions
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Tai Chi Chih
Eligibility Criteria
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Inclusion Criteria
* History of varicella or long term (\>30 years) residence in the continental USA
* Accessible geographically
Exclusion Criteria
* 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
60 Years
90 Years
ALL
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
National Institute on Aging (NIA)
NIH
Principal Investigators
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Michael R. Irwin, MD
Role: PRINCIPAL_INVESTIGATOR
Norman Cousins Professor, Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
Locations
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Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
Los Angeles, California, United States
Countries
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References
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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.
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. doi: 10.1056/NEJMoa051016.
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. doi: 10.1093/ecam/neh048. 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. doi: 10.1097/01.psy.0000088591.86103.8f.
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.
Irwin 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.
Other Identifiers
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AG0029
Identifier Type: -
Identifier Source: org_study_id