Clinical trial NCT06128941: Influence of Hypoxic, Normobaric and Hypobaric Training on the Immunometabolism of Post-covid-19 Athletes
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Normobaric Hypoxia
Hypoventilation
Normoxia
Keywords: HIF1a
HLA-G
Repeated sprint
Inflammation
covid-19
immune system
athletes
Lead sponsor: Faculdade de Motricidade Humana
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2023-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hypoxia Inducible Factor 1 alpha (HIF-1a)
timeFrame: Before, just after and 4 weeks after the training program
measure: Human Leukocyte Antigen-G (HLA-G)
timeFrame: Before, just after and 4 weeks after the training program
measure: Cytokines (TNF-α, IL-1β, IL-6, IL-10, IL-8 and IFN-γ)
timeFrame: Before, just after and 4 weeks after the training program
measure: Plasma levels of eicosanoids, endocannabinoids, steroid hormones, sphingolipids, ceramides and other glycerophospholipids
timeFrame: Before, just after and 4 weeks after the training program
measure: Hematological indicators (hematocrit, hemoglobin and cell count)
timeFrame: Before, just after and 4 weeks after the training program
measure: Ventilatory thresholds and maximum oxygen consumption
timeFrame: Before, just after and 4 weeks after the training program
measure: Blood lactate concentrations
timeFrame: Before, just after and 4 weeks after the training program
measure: Muscle oximetry
timeFrame: Before, just after and 4 weeks after the training program
measure: Peak force
timeFrame: Before, just after and 4 weeks after the training program
Secondary outcomes:
measure: Heart rate
timeFrame: Throughout the training program, 4 weeks
measure: Arterial oxygen saturation
timeFrame: Throughout the training program, 4 weeks
measure: Subjective perception of effort
timeFrame: Throughout the training program, 4 weeks
measure: Blood pressure, heart rate and temperature
timeFrame: Before, just after and 4 weeks after the training program
measure: Anthropometric assessments and body composition
timeFrame: Before, just after and 4 weeks after the training program
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Faculty of Human Kinetics
Study officials:
References: