An interventional study of Repeated sprint in Normobaric Hypoxia, Hypoventilation and Normoxia, sponsored by Faculdade de Motricidade Humana. Recruiting at 1 site in Portugal. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-22.
Sponsored by Faculdade de Motricidade Humana · Not applicable, Interventional, and Basic science
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.
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.
96 studies on the registry are indexed under Hypoventilation; 21 are open to participants now.
This study's planned enrollment of 60 is above the median of 52 across 63 interventional studies indexed under Hypoventilation.
Browse Hypoventilation studies →Faculdade de Motricidade Humana is the lead sponsor of 21 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will carry out training sessions in a normobaric hypoxia chamber at a simulated altitude of 3000 meters (FiO2 14.5%)
Other: Repeated sprint
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
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.
Hypoxia Inducible Factor 1 alpha (HIF-1a)
Flow cytometry for PBMCs
Time frame: Before, just after and 4 weeks after the training program
Human Leukocyte Antigen-G (HLA-G)
ELISA
Time frame: Before, just after and 4 weeks after the training program
Cytokines (TNF-α, IL-1β, IL-6, IL-10, IL-8 and IFN-γ)
ELISA
Time frame: Before, just after and 4 weeks after the training program
Plasma levels of eicosanoids, endocannabinoids, steroid hormones, sphingolipids, ceramides and other glycerophospholipids
Mass Spectrometry (LC-MS/MS)
Time frame: Before, just after and 4 weeks after the training program
Hematological indicators (hematocrit, hemoglobin and cell count)
Blood count
Time frame: Before, just after and 4 weeks after the training program
Ventilatory thresholds and maximum oxygen consumption
mL/kg·min
Time frame: Before, just after and 4 weeks after the training program
Blood lactate concentrations
mmol.L-1
Time frame: Before, just after and 4 weeks after the training program
Muscle oximetry
Near-infrared spectroscopy (NIRS)
Time frame: Before, just after and 4 weeks after the training program
Peak force
Isometric mid thigh pull
Time frame: Before, just after and 4 weeks after the training program
Heart rate
maximum values during the training sessions (bpm)
Time frame: Throughout the training program, 4 weeks
Arterial oxygen saturation
oxymetry (%)
Time frame: Throughout the training program, 4 weeks
Subjective perception of effort
Adapted Borg scale
Time frame: Throughout the training program, 4 weeks
Blood pressure, heart rate and temperature
Values at rest mmHg, bpm and ºC
Time frame: Before, just after and 4 weeks after the training program
Anthropometric assessments and body composition
height (m), body mass (kg), fat free mass (kg), fat mass (kg)
Time frame: Before, just after and 4 weeks after the training program
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Faculdade de Motricidade Humana