Expired Study
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Los Angeles, California 90095


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.


Study summary:

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.


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


Study is Available At:


Original ID:

AG0029


NCT ID:

NCT00118885


Secondary ID:

R01AG18367


Study Acronym:


Brief Title:

Shingles: Immune Effects of Tai Chi


Official Title:

Behavioral Intervention for Herpes Zoster Risk in Aging


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

60 Years


Maximum Age:

90 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Aging (NIA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

140


Enrollment Type:


Overall Contact Information

Official Name:Michael R. Irwin, MD
Principal Investigator
Norman Cousins Professor, Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute

Study Dates

Start Date:July 2001
Completion Date:December 2004
Completion Type:Actual
Primary Completion Date:December 2004
Primary Completion Type:Actual
Verification Date:November 2006
Last Changed Date:December 9, 2009
First Received Date:July 8, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:measures of health status including SF-36 scores, depressive symptoms, and health behaviors
Safety Issues:False
Outcome Type:Primary Outcome
Measure:varicella zoster specific immunity
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Tai Chi Chih

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Aging (NIA)
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Center for Complementary and Alternative Medicine (NCCAM)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:14508027
Reference Type:Reference
Citation: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. Epub 2004 Dec 1.
PMID:15841255
Reference Type:Reference
Citation: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.
PMID:15930418
Reference Type:Reference
Citation:Miller GE, Cohen S. Psychological interventions and the immune system: a meta-analytic review and critique. Health Psychol. 2001 Jan;20(1):47-63.
PMID:11199066

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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