Normobaric HypoxiaNCT06128941
Influence of Hypoxic, Normobaric and Hypobaric Training on the Immunometabolism of Post-covid-19 Athletes
A study testing Repeated sprint in people with Normobaric Hypoxia and Hypoventilation, run by Faculdade de Motricidade Humana at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Normobaric Hypoxia, Hypoventilation, Normoxia
- What is being tested?
- Repeated sprint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 3 Jan 2024to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Human Kinetics
Lisbon, 1495-002 Cruz-Quebrada
Cristina P Monteiro, PhD, 00351214149174, cmonteiro@fmh.ulisboa.pt
About this study
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
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.
Read the 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
- Being tested
- Repeated sprint
- Keywords
- HIF1a, HLA-G, Repeated sprint, Inflammation, covid-19, immune system, athletes
- Medical subject headings
- Hypoventilation, Inflammation, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated sprintOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Normobaric hypoxia (SRH) | Experimental | Participants will carry out training sessions in a normobaric hypoxia chamber at a simulated altitude of 3000 meters (FiO2 14.5%) Receives: Other: Repeated sprint |
| Hypoventilation (SRH-VLH) | Experimental | 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 Receives: Other: Repeated sprint |
| Normoxia (SRN) | Active comparator | Participants will carry out training sessions in normoxia (FiO2 20.9%) Receives: Other: Repeated sprint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxia Inducible Factor 1 alpha (HIF-1a)
Flow cytometry for PBMCs
Measured: Before, just after and 4 weeks after the training program
Human Leukocyte Antigen-G (HLA-G)
ELISA
Measured: 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
Measured: 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)
Measured: Before, just after and 4 weeks after the training program
Hematological indicators (hematocrit, hemoglobin and cell count)
Blood count
Measured: Before, just after and 4 weeks after the training program
Ventilatory thresholds and maximum oxygen consumption
mL/kg·min
Measured: Before, just after and 4 weeks after the training program
Blood lactate concentrations
mmol.L-1
Measured: Before, just after and 4 weeks after the training program
Muscle oximetry
Near-infrared spectroscopy (NIRS)
Measured: Before, just after and 4 weeks after the training program
Peak force
Isometric mid thigh pull
Measured: Before, just after and 4 weeks after the training program
Secondary outcomes (5)
Heart rate
maximum values during the training sessions (bpm)
Measured: Throughout the training program, 4 weeks
Arterial oxygen saturation
oxymetry (%)
Measured: Throughout the training program, 4 weeks
Subjective perception of effort
Adapted Borg scale
Measured: Throughout the training program, 4 weeks
Blood pressure, heart rate and temperature
Values at rest mmHg, bpm and ºC
Measured: 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)
Measured: Before, just after and 4 weeks after the training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start3 Jan 2024
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normobaric HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade de Motricidade Humana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Cristina Monteiro, Faculdade de Motricidade Humana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128941
- Sponsor's protocol ID
- SprintRepHipoxya
- Status last verified
- Feb 2024
- First submitted
- 9 Nov 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06128941
- Acronym / sponsor ID
- SprintRepHipoxya
- Conditions
- Normobaric Hypoxia, Hypoventilation, Normoxia
- Keywords
- HIF1a, HLA-G, Repeated sprint, Inflammation, covid-19, immune system, athletes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Faculdade de Motricidade HumanaUniversity, hospital or other
- Collaborators
- University of Sao Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normobaric hypoxia (SRH) | Experimental | Other: Repeated sprintParticipants will carry out training sessions in a normobaric hypoxia chamber at a simulated altitude of 3000 meters (FiO2 14.5%) |
| Hypoventilation (SRH-VLH) | Experimental | Other: Repeated sprintParticipants 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 |
| Normoxia (SRN) | Active comparator | Other: Repeated sprintParticipants will carry out training sessions in normoxia (FiO2 20.9%) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Hypoventilation (SRH-VLH), Normobaric hypoxia (SRH), Normoxia (SRN) |
Primary outcome
Hypoxia Inducible Factor 1 alpha (HIF-1a)
Time frame: Before, just after and 4 weeks after the training program
Flow cytometry for PBMCs
Human Leukocyte Antigen-G (HLA-G)
Time frame: Before, just after and 4 weeks after the training program
ELISA
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
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
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)
Peak force
Time frame: Before, just after and 4 weeks after the training program
Isometric mid thigh pull
5 secondary outcomes
Heart rate
Time frame: Throughout the training program, 4 weeks
Arterial oxygen saturation
Time frame: Throughout the training program, 4 weeks
Subjective perception of effort
Time frame: Throughout the training program, 4 weeks
Blood pressure, heart rate and temperature
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
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Working in the Heat at Simulated Altitude: Effects of Normobaric Hypoxia on Physiological Strain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated sprint in people with Normobaric Hypoxia and Hypoventilation, run by Faculdade de Motricidade Humana at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Monteiro, PhD (00351214149174, cmonteiro@fmh.ulisboa.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxia Inducible Factor 1 alpha (HIF-1a) (time frame: Before, just after and 4 weeks after the training program). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.