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

February 21, 2024 updated by: Cristina Monteiro, Faculdade de Motricidade Humana

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Portugal
      • Lisbon, Portugal, 1495-002 Cruz-Quebrada
        • Recruiting
        • Faculty of Human Kinetics
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normobaric hypoxia (SRH)
Participants will carry out training sessions in a normobaric hypoxia chamber at a simulated altitude of 3000 meters (FiO2 14.5%)
Other: 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.
Experimental: 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
Other: 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.
Active Comparator: Normoxia (SRN)
Participants will carry out training sessions in normoxia (FiO2 20.9%)
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoxia Inducible Factor 1 alpha (HIF-1a)
Time Frame: Before, just after and 4 weeks after the training program
Flow cytometry for PBMCs
Before, just after and 4 weeks after the training program
Human Leukocyte Antigen-G (HLA-G)
Time Frame: Before, just after and 4 weeks after the training program
ELISA
Before, just after and 4 weeks after the training program
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
Before, just after and 4 weeks after the training program
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)
Before, just after and 4 weeks after the training program
Hematological indicators (hematocrit, hemoglobin and cell count)
Time Frame: Before, just after and 4 weeks after the training program
Blood count
Before, just after and 4 weeks after the training program
Ventilatory thresholds and maximum oxygen consumption
Time Frame: Before, just after and 4 weeks after the training program
mL/kg·min
Before, just after and 4 weeks after the training program
Blood lactate concentrations
Time Frame: Before, just after and 4 weeks after the training program
mmol.L-1
Before, just after and 4 weeks after the training program
Muscle oximetry
Time Frame: Before, just after and 4 weeks after the training program
Near-infrared spectroscopy (NIRS)
Before, just after and 4 weeks after the training program
Peak force
Time Frame: Before, just after and 4 weeks after the training program
Isometric mid thigh pull
Before, just after and 4 weeks after the training program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: Throughout the training program, 4 weeks
maximum values during the training sessions (bpm)
Throughout the training program, 4 weeks
Arterial oxygen saturation
Time Frame: Throughout the training program, 4 weeks
oxymetry (%)
Throughout the training program, 4 weeks
Subjective perception of effort
Time Frame: Throughout the training program, 4 weeks
Adapted Borg scale
Throughout the training program, 4 weeks
Blood pressure, heart rate and temperature
Time Frame: Before, just after and 4 weeks after the training program
Values at rest mmHg, bpm and ºC
Before, just after and 4 weeks after the training program
Anthropometric assessments and body composition
Time Frame: Before, just after and 4 weeks after the training program
height (m), body mass (kg), fat free mass (kg), fat mass (kg)
Before, just after and 4 weeks after the training program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculdade de Motricidade Humana

Collaborators

University of Sao Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2024

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SprintRepHipoxya

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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