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Clinical Trials/NCT06128941
NCT06128941
Recruiting
Not Applicable

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 Humana1 site in 1 country60 target enrollmentJanuary 3, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Normobaric Hypoxia
Sponsor
Faculdade de Motricidade Humana
Enrollment
60
Locations
1
Primary Endpoint
Hypoxia Inducible Factor 1 alpha (HIF-1a)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2024
End Date
June 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cristina Monteiro

Assistant professor

Faculdade de Motricidade Humana

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.

Outcomes

Primary Outcomes

Hypoxia Inducible Factor 1 alpha (HIF-1a)

Time Frame: 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)

Time Frame: Before, just after and 4 weeks after the training program

ELISA

Human Leukocyte Antigen-G (HLA-G)

Time Frame: Before, just after and 4 weeks after the training program

ELISA

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

Time Frame: Before, just after and 4 weeks after the training program

Mass Spectrometry (LC-MS/MS)

Hematological indicators (hematocrit, hemoglobin and cell count)

Time Frame: Before, just after and 4 weeks after the training program

Blood count

Peak force

Time Frame: Before, just after and 4 weeks after the training program

Isometric mid thigh pull

Ventilatory thresholds and maximum oxygen consumption

Time Frame: Before, just after and 4 weeks after the training program

mL/kg·min

Blood lactate concentrations

Time Frame: Before, just after and 4 weeks after the training program

mmol.L-1

Muscle oximetry

Time Frame: Before, just after and 4 weeks after the training program

Near-infrared spectroscopy (NIRS)

Secondary Outcomes

  • 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)

Study Sites (1)

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