Aging Clinical Trial - Shingles: Immune Effects of Tai Chi

Status Completed

Clinical Trial 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.

Clinical Trial 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:

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00118885
Study type	Interventional
Source	National Institute on Aging (NIA)
Contact
Status	Completed
Phase	Phase 2
Start date	July 2001
Completion date	December 2004

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.