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Shingles: Immune Effects of Tai Chi

Primary Purpose

Aging, Herpes Zoster

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tai Chi Chih
Sponsored by
National Institute on Aging (NIA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging focused on measuring Shingles, depression, varicella zoster virus, alternative medicine, psychoneuroimmunology

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute

Outcomes

Primary Outcome Measures

varicella zoster specific immunity

Secondary Outcome Measures

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

Full Information

First Posted
July 8, 2005
Last Updated
December 9, 2009
Sponsor
National Institute on Aging (NIA)
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00118885
Brief Title
Shingles: Immune Effects of Tai Chi
Official Title
Behavioral Intervention for Herpes Zoster Risk in Aging
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Aging (NIA)
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Herpes Zoster
Keywords
Shingles, depression, varicella zoster virus, alternative medicine, psychoneuroimmunology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
140 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Tai Chi Chih
Primary Outcome Measure Information:
Title
varicella zoster specific immunity
Secondary Outcome Measure Information:
Title
measures of health status including SF-36 scores, depressive symptoms, and health behaviors

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R. Irwin, MD
Organizational Affiliation
Norman Cousins Professor, Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cousins Center for Psychoneuroimmunology, UCLA Neuropsychiatric Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11199066
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. doi: 10.1037//0278-6133.20.1.47.
Results Reference
background
PubMed Identifier
15930418
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. doi: 10.1056/NEJMoa051016.
Results Reference
background
PubMed Identifier
15841255
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. doi: 10.1093/ecam/neh048. Epub 2004 Dec 1.
Results Reference
background
PubMed Identifier
14508027
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. doi: 10.1097/01.psy.0000088591.86103.8f.
Results Reference
background
PubMed Identifier
21934474
Citation
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.
Results Reference
derived
PubMed Identifier
18652095
Citation
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.
Results Reference
derived

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Shingles: Immune Effects of Tai Chi

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