Behavioral Intervention for Herpes Zoster Risk in Aging
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- varicella zoster specific immunity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
varicella zoster specific immunity
次要结局
- measures of health status including SF-36 scores, depressive symptoms, and health behaviors