跳至主要内容
临床试验/NCT03736759
NCT03736759已完成不适用

Resistance Exercise to Improve Vaccine Outcomes in Older Adults

University of Houston2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2018年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Cell mediated immunity change at 6 weeks post-vaccine

研究概览

简要总结

This study evaluates whether resistance exercise will improve immune responses to the seasonal influenza vaccine in older adults. One third of the participants will perform exercise in the arm that receives the vaccine, one third of the participants will perform the same exercise in the arm that does not receive the vaccine, and one third will only receive the vaccine.

详细描述

Resistance exercise, particularly novel eccentric exercise, recruits immune cells to the targeted muscle. The exercises selected here targets the deltoid and biceps brachii muscles-those same muscles that the flu vaccine is delivered to during typical vaccination.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • non-frail older adult (≥65 years old) of any sex and race/ethnicity
  • non-smokers (>10 yrs)
  • meets American College of Sports Medicine criteria for participation in exercise
  • US resident

排除标准

  • underlying medical problems that contraindicate supervised resistance exercise
  • past or present history of autoimmune disease, HIV, hepatitis, stroke, or cardiovascular disease
  • current debilitating arthritis of the shoulder
  • central or peripheral nervous disorders
  • bedridden in the past three months
  • history of vaccine-related allergies, or severe egg allergy;
  • physician-confirmed influenza infection in the prior year
  • regular user of corticosteroids
  • functional or cognitive impairment that would limit exercise performance or prohibit informed consent
  • blood pressure greater than 160/90
  • participation in resistance arm exercises in the prior 6 months

结局指标

主要结局

Cell mediated immunity change at 6 weeks post-vaccine

时间窗: baseline and 6 weeks

The change in the peripheral blood mononuclear cell response to overnight ex vivo culture with the seasonal quadrivalent vaccine detected via Interferon-gamma ELISPOT will be calculated from baseline at 6 weeks post-vaccine

Antibody titer change at 6 weeks post-vaccine

时间窗: baseline and 6 weeks

The change in influenza-specific antibody titers in serum measured by hemagglutination inhibition assay will be calculated from baseline at 6 weeks post-vaccine

Antibody titer change at 6 months post-vaccine

时间窗: baseline and 6 months

The change in influenza-specific antibody titers in serum measured by hemagglutination inhibition assay will be calculated from baseline at 6 months post-vaccine

Cell mediated immunity change at 6 months post-vaccine

时间窗: baseline and 6 months

The change in the peripheral blood mononuclear cell response to overnight ex vivo culture with the seasonal quadrivalent vaccine detected via Interferon-gamma ELISPOT will be calculated from baseline at 6 months post-vaccine

次要结局

  • Influenza-like symptoms(Measured monthly for six months)
  • Muscle soreness(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily C Lavoy

Assistant Professor

University of Houston

研究点 (2)

Loading locations...

相似试验