Influence of Hypoxic, Normobaric and Hypobaric Training on the Immunometabolism of Post-covid-19 Athletes

NCT ID: NCT06128941

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-03
• Study Completion Date: 2024-06-30

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.

Conditions

Normobaric Hypoxia; Hypoventilation; Normoxia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Normobaric hypoxia (SRH)

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

Group Type: EXPERIMENTAL

Repeated sprint

Intervention Type: OTHER

• Duration of the study: 8 weeks of participation.
• Each repeated sprint training protocol: 2 training sessions per week for 4 weeks.
• Collection sessions: 3 collection sessions will be carried out: before the start of the training protocol - T0; at the end of the protocol, in week 4 - T1; and late, 4 weeks after the end of the protocol, in week 8 - T2.
• Training sessions: will be carried out on an ergometer and will consist of 3 sets of 5 sprints of 10s all-out with 20s of rest between sprints, and 5 minutes of rest between sets.

Hypoventilation (SRH-VLH)

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

Group Type: EXPERIMENTAL

Repeated sprint

Intervention Type: OTHER

• Duration of the study: 8 weeks of participation.
• Each repeated sprint training protocol: 2 training sessions per week for 4 weeks.
• Collection sessions: 3 collection sessions will be carried out: before the start of the training protocol - T0; at the end of the protocol, in week 4 - T1; and late, 4 weeks after the end of the protocol, in week 8 - T2.
• Training sessions: will be carried out on an ergometer and will consist of 3 sets of 5 sprints of 10s all-out with 20s of rest between sprints, and 5 minutes of rest between sets.

Normoxia (SRN)

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

Group Type: ACTIVE_COMPARATOR

Repeated sprint

Intervention Type: OTHER

• Duration of the study: 8 weeks of participation.
• Each repeated sprint training protocol: 2 training sessions per week for 4 weeks.
• Collection sessions: 3 collection sessions will be carried out: before the start of the training protocol - T0; at the end of the protocol, in week 4 - T1; and late, 4 weeks after the end of the protocol, in week 8 - T2.
• Training sessions: will be carried out on an ergometer and will consist of 3 sets of 5 sprints of 10s all-out with 20s of rest between sprints, and 5 minutes of rest between sets.

Interventions

Repeated sprint

• Duration of the study: 8 weeks of participation.
• Each repeated sprint training protocol: 2 training sessions per week for 4 weeks.
• Collection sessions: 3 collection sessions will be carried out: before the start of the training protocol - T0; at the end of the protocol, in week 4 - T1; and late, 4 weeks after the end of the protocol, in week 8 - T2.
• Training sessions: will be carried out on an ergometer and will consist of 3 sets of 5 sprints of 10s all-out with 20s of rest between sprints, and 5 minutes of rest between sets.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Faculdade de Motricidade Humana

OTHER

Sponsor Role: lead

Responsible Party

Cristina Monteiro

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Human Kinetics

Lisbon, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Cristina Monteiro, PhD

Role: CONTACT

cmonteiro@fmh.ulisboa.pt

00351214149174

Joana Reis, PhD

Role: CONTACT

joanareis@fmh.ulisboa.pt

00351214149174

Facility Contacts

Cristina P Monteiro, PhD

Role: primary

cmonteiro@fmh.ulisboa.pt

00351214149174

Other Identifiers

SprintRepHipoxya

Identifier Type: -

Identifier Source: org_study_id