NCT06128941

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 3, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

November 9, 2023

Last Update Submit

February 21, 2024

Conditions

Keywords

HIF1aHLA-GRepeated sprintInflammationcovid-19immune systemathletes

Outcome Measures

Primary Outcomes (9)

  • Hypoxia Inducible Factor 1 alpha (HIF-1a)

    Flow cytometry for PBMCs

    Before, just after and 4 weeks after the training program

  • Human Leukocyte Antigen-G (HLA-G)

    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)

    ELISA

    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)

    Before, just after and 4 weeks after the training program

  • Hematological indicators (hematocrit, hemoglobin and cell count)

    Blood count

    Before, just after and 4 weeks after the training program

  • Ventilatory thresholds and maximum oxygen consumption

    mL/kg·min

    Before, just after and 4 weeks after the training program

  • Blood lactate concentrations

    mmol.L-1

    Before, just after and 4 weeks after the training program

  • Muscle oximetry

    Near-infrared spectroscopy (NIRS)

    Before, just after and 4 weeks after the training program

  • Peak force

    Isometric mid thigh pull

    Before, just after and 4 weeks after the training program

Secondary Outcomes (5)

  • Heart rate

    Throughout the training program, 4 weeks

  • Arterial oxygen saturation

    Throughout the training program, 4 weeks

  • Subjective perception of effort

    Throughout the training program, 4 weeks

  • Blood pressure, heart rate and temperature

    Before, just after and 4 weeks after the training program

  • Anthropometric assessments and body composition

    Before, just after and 4 weeks after the training program

Study Arms (3)

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%)

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

Other: Repeated sprint

Normoxia (SRN)

ACTIVE COMPARATOR

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

Other: Repeated sprint

Interventions

* 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)Normobaric hypoxia (SRH)Normoxia (SRN)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Human Kinetics

Lisbon, 1495-002 Cruz-Quebrada, Portugal

RECRUITING

MeSH Terms

Conditions

HypoventilationInflammationCOVID-19

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung Diseases

Central Study Contacts

Cristina Monteiro, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 13, 2023

Study Start

January 3, 2024

Primary Completion

April 1, 2024

Study Completion

June 1, 2024

Last Updated

February 22, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations