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临床试验/NCT05826496
NCT05826496已完成不适用

Characterization of Immunological Parameters in Blood from Healthy Participants Before and After High- to Moderate-intensity Aerobic Exercise

Per thor Straten2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2023年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
59
试验地点
2
主要终点
Virus-specific T cell responses

研究概览

简要总结

Exercise has been shown to influence the immune system and, for example, improve anti-viral immune response. However, knowledge of how exercise impacts the immune system is still lacking. Therefore, the goal of this clinical study is to perform a comprehensive multi-parameter analysis of immunological parameters in healthy participants before and after one bout of high-intensity aerobic exercise. The primary endpoint of this study is to determine the exercise-induced changes of anti-viral T cell immunity in peripheral blood against common and recurrent viruses.

Up to 70 healthy participants in the age between 18 and 75 will be recruited. The first visit will be for prescreening the health status, answering questionnaires and providing a capillary blood sample for HLA screening. HLA-A2 positive participants will continue on the trial with a VO2 max test for Visit 2 and the supervised aerobic medium- to high-intensity (90% VO2 max) exercise session for Visit 3. Peripheral blood samples will be taken pre-exercise, within 2 minutes post-exercise and 60 minutes post-exercise.

These findings may pave the way to define serum markers or cellular immunological traits that provide new insight into how exercise promotes powerful and sustained cellular immune responses.

详细描述

Numerous physiological parameters are influenced by exercise, including marked changes on numerous markers of the immune system. It has been shown that exercise lowers systemic low-grade inflammation, and there are indications that exercise improves the ability to combat infections and vaccination-induced immune responses.

Exercise has been repeatedly shown to mobilize immune cells into peripheral blood - most pronouncedly prototype killer cells of both the innate and adaptive immune system namely Natural Killer (NK) and T cells. Both cell types are critical in immune responses against viral infections and are also key effector cells in anti-cancer immune responses. Even more so, previously activated NK and T cells are selectively mobilized, potentially providing the background for exercise-mediated stronger anti-viral immunity.

In this study, the blood samples will be used to study global viral T cell reactivity against chronic [Cytomegalovirus (CMV) and Ebstein-Barr virus (EBV)] and recurrent [Influenza (flu) and SARS-CoV-2] viruses and detect their exact frequencies in peripheral blood. Since the technique is optimized for HLA*A2:01 positive individuals, this study will include a prescreening to match this tissue type. Adding more complexity to the acquired data, further analyses include but are not limited to phenotyping by CyTOF and flow cytometry as well as Luminex immune assays.

The current study will provide important insight into how the immune system is influenced by acute medium-to high-intensity exercise. These findings may have important implications for vaccine development, prevention in frail and at-risk populations, cancer prevention and cancer therapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have the ability to speak and read English and/or Danish.
  • Agree to avoid alcohol, nonprescription drugs, and strenuous exercise for 24 hours prior VO2 max test and exercise intervention.
  • Signed informed consent.

排除标准

  • Autoimmune disease requiring active treatment.
  • A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications. Inhaled or topical steroids and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted
  • Use of medication known to affect the immune system (regular use of ibuprofen/aspirin or beta-blockers).
  • Any systemic infections with fever within the last 4 weeks before the exercise intervention.
  • Use of any illegal drugs (e.g., cocaine, amphetamine).
  • Conditions with high risk for complications during exercise: Unstable medical disease, condition, or history of serious or concurrent illness; any medical condition that might be aggravated by exercise training or that cannot be controlled, including, but not restricted to congestive heart failure (NYHA class III-IV), unstable angina pectoris, implantable cardioverter defibrillator (ICD), or myocardial infarction within 6 months.

研究组 & 干预措施

Exercise

Experimental

HLA-A2 positive participants will perform one bout of high-intensity interval training.

干预措施: Exercise (Other)

结局指标

主要结局

Virus-specific T cell responses

时间窗: 6 months

Investigate the number of virus-reactive CD8+ T cells at baseline, within 2 minutes after cessation and 60 minutes after cessation of the exercise bout in peripheral blood using DNA-barcoded peptide-MHC multimer assay.

次要结局

  • Phenotypes of exercise-mobilized immune cells(6 months)
  • Circulating soluble markers(1 year)

研究者

发起方
Per thor Straten
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Per thor Straten

Professor

Herlev Hospital

研究点 (2)

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