跳至主要内容
临床试验/NCT06128941
NCT06128941招募中不适用

Influence of Physical Training Protocols in Hypoxic, Normobaric and Hypobaric Environments, on the Immune, Metabolic Response and Cardiopulmonary Behavior in Athletes Convalescent From Covid-19

Faculdade de Motricidade Humana2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Hypoxia Inducible Factor 1 alpha (HIF-1a)

研究概览

简要总结

COVID-19 has significantly impacted sports globally, with event postponements, training disruptions, and wide-ranging concerns. SARS-CoV-2 infection can result in hyperinflammation and cardiopulmonary changes, with hypoxia as an aggravating sign. Hypoxia triggers complex immunometabolic mechanisms, including activation of HIF-1α and induction of HLA-G expression. Hypoxia training protocols benefit aerobic capacity and sports performance, with potential immunological impact. Studying immunometabolic markers in this context can improve athletic preparation and athletes' general health.

详细描述

Covid-19, caused by SARS-CoV-2, can progress to pulmonary hyperinflammation and cardiopulmonary changes, with hypoxia being one of the main signs of worsening. In hypoxia, there is activation of HIF-1 that induces the expression of HLA-G, an immuno-tolerogenic molecule that inhibits the hyperinflammatory response. Hypoxia training protocols can promote cardiopulmonary benefits and increase the expression of anti-inflammatory cytokines, HIF-1 and HLA-G. Immunometabolic markers have the potential to be used in the prevention, diagnosis, and treatment of diseases with inflammatory mechanisms. The objective of this study is to evaluate the influence of physical training protocols in hypoxic, normobaric, and hypobaric environments, on the immune, and metabolic response and cardiopulmonary behavior in athletes post covid-19, to identify potential biomarkers and better clarify the impact of exercise on immunometabolism post-covid-19. The study will consist of a randomized and controlled intervention, with training using different normobaric hypoxic methods; and an observational study at natural altitude (hypobaric hypoxia). In the normobaric hypoxia trial, participants will be divided into a control group that will carry out a training plan of repeated sprints in normoxia; and two other groups that will perform the same training sessions in normobaric hypoxia and with low lung volume voluntary hypoventilation. In the observational study with hypobaric hypoxia, high-performance resistance athletes will be recruited, who will comply with the training plan proposed by the team's coach at altitude. Cardiorespiratory, immunometabolic, neuromuscular, and autonomic fatigue, hematological indicators, plasma levels of lipid mediators, sHLA-G and cytokines, and the expression of HIF-1α in leukocyte cells will be evaluated. The analysis of the effect of the training methods will be carried out by ANOVA for repeated measures (parametric or non-parametric), or means comparison tests for paired samples (t or Wilcoxon) after evaluating the assumptions and the identification of associations between variables will be carried out by Binomial Logistic Regression Analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • more than 5 years of training experience in an resistance modality;
  • participates in national or international championships regularly;
  • athletes convalescing from covid-19, at least 30 days after diagnosis and/or hospital discharge;
  • manifested mild to severe symptoms;
  • vaccinated or not against SARS-CoV-2;
  • antigen self-test for SARS-CoV-2 negative.

排除标准

  • athletes who have had an acclimatization experience or exposure to altitude lasting more than 10 days in the last 6 months;
  • contain signs or symptoms of acute covid-19;
  • present a positive SARS-CoV-2 antigen self-test;
  • pregnant or postpartum women;
  • use anti-inflammatory or immunosuppressive medications.

研究组 & 干预措施

Normobaric hypoxia (SRH)

Experimental

Participants will carry out training sessions in a normobaric hypoxia chamber at a simulated altitude of 3000 meters (FiO2 14.5%)

干预措施: Repeated sprint (Other)

Hypoventilation (SRH-VLH)

Experimental

Participants will be asked to exhale to residual functional capacity, immediately before starting each sprint, and to hold their breath until the end of the sprint

干预措施: Repeated sprint (Other)

Normoxia (SRN)

Active Comparator

Participants will carry out training sessions in normoxia (FiO2 20.9%)

干预措施: Repeated sprint (Other)

结局指标

主要结局

Hypoxia Inducible Factor 1 alpha (HIF-1a)

时间窗: Before, just after and 4 weeks after the training program

Flow cytometry for PBMCs

Cytokines (TNF-α, IL-1β, IL-6, IL-10, IL-8 and IFN-γ)

时间窗: Before, just after and 4 weeks after the training program

ELISA

Human Leukocyte Antigen-G (HLA-G)

时间窗: Before, just after and 4 weeks after the training program

ELISA

Plasma levels of eicosanoids, endocannabinoids, steroid hormones, sphingolipids, ceramides and other glycerophospholipids

时间窗: Before, just after and 4 weeks after the training program

Mass Spectrometry (LC-MS/MS)

Hematological indicators (hematocrit, hemoglobin and cell count)

时间窗: Before, just after and 4 weeks after the training program

Blood count

Peak force

时间窗: Before, just after and 4 weeks after the training program

Isometric mid thigh pull

Ventilatory thresholds and maximum oxygen consumption

时间窗: Before, just after and 4 weeks after the training program

mL/kg·min

Blood lactate concentrations

时间窗: Before, just after and 4 weeks after the training program

mmol.L-1

Muscle oximetry

时间窗: Before, just after and 4 weeks after the training program

Near-infrared spectroscopy (NIRS)

次要结局

  • Heart rate(Throughout the training program, 4 weeks)
  • Arterial oxygen saturation(Throughout the training program, 4 weeks)
  • Subjective perception of effort(Throughout the training program, 4 weeks)
  • Blood pressure, heart rate and temperature(Before, just after and 4 weeks after the training program)
  • Anthropometric assessments and body composition(Before, just after and 4 weeks after the training program)

研究者

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

Cristina Monteiro

Assistant professor

Faculdade de Motricidade Humana

研究点 (2)

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