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

Hypoventilation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128941
• Other study ID #: SprintRepHipoxya
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Faculdade de Motricidade Humana
• Contact: Cristina Monteiro, PhD
• Phone: 00351214149174
• Email: cmonteiro[@]fmh.ulisboa.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Hypoventilation
• Hypoxia
• Normoxia

Intervention

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.

Locations

Country	Name	City	State
Portugal	Faculty of Human Kinetics	Lisbon

Sponsors (3)

Lead Sponsor	Collaborator
Faculdade de Motricidade Humana	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., University of Sao Paulo

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxia Inducible Factor 1 alpha (HIF-1a)	Flow cytometry for PBMCs	Before, just after and 4 weeks after the training program
Primary	Human Leukocyte Antigen-G (HLA-G)	ELISA	Before, just after and 4 weeks after the training program
Primary	Cytokines (TNF-a, IL-1ß, IL-6, IL-10, IL-8 and IFN-?)	ELISA	Before, just after and 4 weeks after the training program
Primary	Plasma levels of eicosanoids, endocannabinoids, steroid hormones, sphingolipids, ceramides and other glycerophospholipids	Mass Spectrometry (LC-MS/MS)	Before, just after and 4 weeks after the training program
Primary	Hematological indicators (hematocrit, hemoglobin and cell count)	Blood count	Before, just after and 4 weeks after the training program
Primary	Ventilatory thresholds and maximum oxygen consumption	mL/kg·min	Before, just after and 4 weeks after the training program
Primary	Blood lactate concentrations	mmol.L-1	Before, just after and 4 weeks after the training program
Primary	Muscle oximetry	Near-infrared spectroscopy (NIRS)	Before, just after and 4 weeks after the training program
Primary	Peak force	Isometric mid thigh pull	Before, just after and 4 weeks after the training program
Secondary	Heart rate	maximum values during the training sessions (bpm)	Throughout the training program, 4 weeks
Secondary	Arterial oxygen saturation	oxymetry (%)	Throughout the training program, 4 weeks
Secondary	Subjective perception of effort	Adapted Borg scale	Throughout the training program, 4 weeks
Secondary	Blood pressure, heart rate and temperature	Values at rest mmHg, bpm and ºC	Before, just after and 4 weeks after the training program
Secondary	Anthropometric assessments and body composition	height (m), body mass (kg), fat free mass (kg), fat mass (kg)	Before, just after and 4 weeks after the training program