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临床试验/NCT00548990
NCT00548990已完成不适用

Physical Activity, Aging and Immune Function

National Institute on Aging (NIA)2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2002年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
antibody responses to influenza and tetanus toxoid vaccination and delayed type hypersensitivity responses to fungal antigens

研究概览

简要总结

The purpose of the study is to examine whether cardiovascular exercise training improves immune responses to vaccination in previously sedentary older adults.

详细描述

The extent to which exercise training or long-term physical activity influences poorly regulated immune function in the elderly is unclear. Preliminary evidence suggests that exercise training may improve various immune function measures in older adults. Although such findings have the potential to be of substantial public health importance, the majority of studies have suffered from small sample sizes, inadequate measurement of physical fitness, and weak research designs.

This study is designed to overcome these limitations by employing a longitudinal randomized controlled trial examining the effect of exercise training on clinically relevant immune function measures in older adults (65-80 years). Moreover, relationships between several factors known to be altered by exercise training and changes in immune function will be assessed. As such, there are two specific aims to be addressed. In Aim 1, a 10-month exercise trial will determine whether moderate intensity aerobic exercise training can improve immune function in previously sedentary older adults. In Aim 2, the role played by physiological, behavioral, and psychosocial factors in the relationship between exercise training and improved immune function will be examined.

150 sedentary participants will be randomly assigned to either a 10-month moderate aerobic exercise training program or a sedentary control group. Clinically relevant measures of immune function including the delayed-type hypersensitivity (DTH) response to a battery of antigens and the antibody response to tetanus toxoid and influenza virus vaccination will be assessed before, during and after the intervention. We hypothesize that exercise training will result in improved immune responses including higher peak antibody titers and DTH responses, and sustained levels of protective antibodies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single

入排标准

年龄范围
62 Years 至 82 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 62-82
  • Ability to participate in an exercise program
  • Medical clearance by primary physician
  • Non-smoker
  • BMI 22-38
  • Independently living
  • Post-menopausal
  • Sedentary for over 6 months

排除标准

  • No recent history (within 6 months) of infection or vaccination
  • History of systemic reactions to vaccination
  • History of cancer
  • Severe allergies/asthma requiring prescription medication
  • Splenectomy or transplant patient
  • Chronic Obstructive Pulmonary Disease (COPD)
  • HIV positive
  • Uncontrolled diabetes or hypertension
  • Severe arthritis
  • Mental illness or clinical depression
  • Impaired cognitive status

结局指标

主要结局

antibody responses to influenza and tetanus toxoid vaccination and delayed type hypersensitivity responses to fungal antigens

时间窗: baseline, 6 and 10 months

次要结局

  • cardiovascular fitness
  • psychosocial outcomes

研究者

发起方
National Institute on Aging (NIA)
申办方类型
Nih

研究点 (2)

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