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Completed

NCT Number: NCT06806124

Impact of the Elevation Training Mask in CrossFit® Post-SARS-CoV-2 Infection.

Introduction: The Elevation Training Mask (ETM) could restore respiratory or hematological organic damages from the acute or post-infection phase of severe acute respiratory syndrome coronavirus 2 (SARSCoV2) because it would allow the application of hypoxia and respiratory muscle training during exercise. The aim of this study was to comparatively evaluate the respiratory and hematological parameters and performance of athletes who resume CrossFit® training using the ETM with respect to a control group (CG).

Material and methods: A single-blind randomized clinical trial, following the CONSORT ("Consolidated Standards of Reporting Trials") recommendations, 20 trained male athletes were randomly assigned to an experimental group (EG) using the ETM and to a CG using the simulated ETM, they completed 12 weeks of CrossFit® training after 1 month of the cessation of SARS-CoV-2 symptoms. Pre- and post-training tests included spirometric, hematological, and sports performance assessment.

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Key information

Conditions

COVID19- Infection with SARS-CoV-2 Virus COVID-19 COVID-19 Pulmonary Complications Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Infection (Symptomatic) SARS-CoV-2 Positive Patients Virus Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cell Biology, Genetics, Histology and Pharmacology of the University of Valladolid

Soria, 42005, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male aged 18 to 50 years.
  • Autonomy in training activities of CrossFit® programs, at least 1 month after the cessation of symptoms of SARS-CoV-2 infection -2 infection.
  • No hospitalization for COVID-19.
  • Autonomy in training activities of CrossFit® programs, at least 1 month after the cessation of symptoms of SARS-CoV-2 infection, to avoid residual effects of the disease and increase the safety of the athlete.
  • ≥20 months of experience training CrossFit®.
  • ≥2 participations in CrossFit® competitions in the last season.
  • Having completed Fran WODs ≤ 250 seconds before suffering from COVID-19. - Passing a complete pre-study medical examination to rule out pre-existing diseases or injuries, insisting particularly on the cardio-pulmonary examination.-- No consumption of illegal drugs according to the World Anti-Doping Agency (WADA) (stimulants, blood derivatives, anabolic) or take drugs (e.g. tramadol) or other ergogenic products.
  • Be informed about all possible risks or discomforts and benefits associated with the study and sign the informed consent form;.
  • Health sports insurance coverage.

Exclusion criteria

  • Included any renal dysfunction, recent febrile illness, lower limb trauma or any history of muscle injury.
  • SARS-CoV-2 reinfection during the study.
  • Recent exposure to an altitude stimulus or hypoxia, except for the altitude of their usual residence (1063 m in Soria and 798 m in Salamanca).
  • Participants were also prevented to perform any intense physical activity outside the designed training protocol throughout the study and encouraged to follow the dietary instructions provided.

Treatment and study plan

Elevation Training Mask

Device

The Elevation Training Mask (ETM) 2.0 was used in all 36 training sessions over the 12 weeks of the study with progressive increases in air restriction to simulate altitude training. This methodology of using ETM during exercise was chosen following the study by Porcari et al. The first week, the additional altitude simulation was 914 m and in the second, 1,829 m. These initial 2 weeks served to adjust the use of the ETM during training, as a process of acclimatization to the altitude simulation and airflow restriction. For the period between weeks 3 and 6 (both inclusive) the simulated altitude was 2,743 m, and for weeks 7-12 (both inclusive), the ETM was set to simulate 3658 m altitude.

Other names: Experimental Group

Sham Elevation Training Mask

Device

For the Control Group, the Elevation Training Mask (ETM) 2.0 was used for 12 weeks with the largest openings available and without using the air restriction filters, so that there was little respiratory obstruction and the reduction in air flow was minimal, with the aim of having a simulated ETM treatment

Other names: Control Group

Primary outcomes

  1. maximum inspiratory pressure (MIP)

    Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

    Maximal inspiratory pressure (MIP) evaluation in centimeters of water (cmH2O). MIP is a measure of the strength of inspiratory muscles, primarily the diaphragm, and allows for the assessment of ventilatory failure, restrictive lung disease and respiratory muscle strength.

  2. maximum expiratory pressure (MEP)

    Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

    Evaluation maximal expiratory pressure (MEP) aluation in centimeters of water (cmH2O). MEP measures the maximum positive pressure that can be generated from one expiratory effort starting from total lung capacity

Secondary outcomes

  1. forced vital capacity (FVC)

    Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

    Evaluation of Forced vital capacity (FVC) in Liters (L). FVC is a pulmonary function measurement that represents the total amount of air a person can forcibly exhale from their lungs after taking the deepest breath possible.

  2. forced expiratory capacity in 1 second (FEV1)

    Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

    Evaluation of forced expiratory capacity in 1 second (FEV1) in Liters (L). FEV1 indicates the volume of air a person can forcefully exhale in one second.

  3. maximum voluntary ventilation (MVV)

    Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

    Evaluation of Maximal Voluntary Ventilation (MVV) in Liters / minute (L/min). MVV is a measure of the maximum amount of air a person can breathe in and out within a specific time frame, typically one minute

  4. vital capacity (VC)

    Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

    Evaluation of vital capacity (VC) in in Liters (L).

  5. red blood cells (RBC)

    Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

    Erythrocytes, red blood cells (RBC), are the functional components of blood responsible for transporting gases and nutrients throughout the human body. Evaluation of RBC million / microliter (mill/µL).

  6. Hemoglobin (Hb)

    Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

    Hemoglobin (Hb) is the protein molecule in red blood cells that carries oxygen from the lungs to the body's tissues and returns carbon dioxide from the tissues back to the lungs. Hgb is made up of four protein molecules (globulin chains) that are connected. Evaluation of Hb in grams / deciliter (g/dL).

  7. hematocrit (Hct)

    Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

    A hematocrit test (Hct) is a simple blood test that measures the percentage of red blood cells in your blood. Evaluation of Hct in Percentage (%).

  8. reticulocytes (RET)

    Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

    Reticulocytes are immature red blood cells (RBCs) produced in the bone marrow and released into the peripheral blood, where they mature into RBCs within 1 to 2 days. Evaluation of Reticulocytes in Percentage (%).

  9. erythropoietin (EPO)

    Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

    Erythropoietin (EPO) is a hormone that regulates the production of red blood cells. It is produced by kidney cells in response to low oxygen levels in the tissues. EPO promotes the formation of red blood cells by the bone marrow. EPO deficiency can result in reduced production of red blood cells, leading to anemia. EPO is also known as eritropoyetina or hemopoyetina. Evaluation of EPO in milliunits/milliliter (mU/mL).

Other outcomes

  1. Fran WOD

    Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

    Work of the Day (WOD): Perform the 21 Thrusters and 21 Pull-Ups, then 15 Thrusters and 15 Pull-Ups, then 9 Thrusters and 9 Pull-Ups, as fast as possible. Evaluation of Fran WOD in seconds (s).

  2. CrossFit® Total

    Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

    Work of the Day (WOD): Sum of the best of 3 attempts at each lift:

    Back Squat; Shoulder Press; Deadlift. Attempt each lift 3 times. The weight must increase after each successful attempt at each movement. The weight may not be decreased after the first attempt. A failed rep counts as an attempt. Take the Back Squat and Shoulder Press (aka: Strict Press) from the weight rack. Evaluation of CrossFit® Total in kilograms (Kg).

Sponsors and collaborators

Lead sponsor

University of Valladolid

Other

Registry information

Official study title

Analysis of Hematological Biomarkers, Muscle Respiratory Function and Sports Performance in CrossFit® Athletes Using the Elevation Training Mask 2.0 Upon Return to a High-intensity Training Program After Recovering from COVID-19. a Single-blind, Multicenter, Randomized Clinical Trial.

Acronym: ETMEXCOVID

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 3, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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