An interventional study of Elevation Training Mask and Sham Elevation Training Mask in COVID19- Infection with SARS-CoV-2 Virus, SARS-CoV-2 Positive Patients and COVID-19 Pulmonary Complications, sponsored by University of Valladolid. Completed at 1 site in Spain. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by University of Valladolid · Not applicable, Interventional, and Treatment
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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Exclusion Criteria:
Elevation Training Mask (ETM) using the corresponding air restriction openings and filters. The first week, the additional altitude simulation was 914 m and the second, 1,829 m. These initial 2 weeks served to familiarize to 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 included) the simulated altitude was 2,743 m, and for weeks 7-12 (both included), the ETM was set to simulate 3,658 m altitude.
Device: Elevation Training Mask
For the Control Group, the Elevation Training Mask (ETM) was used for 12 weeks with the largest openings available and without using the air restriction filters, so that there was little respiratory obstruction but the reduction in air flow was minimal, with the aim of having a simulated ETM treatment.
Device: Sham Elevation Training Mask
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.
Also known as: Experimental Group
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
Also known as: Control Group
maximum inspiratory pressure (MIP)
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.
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
maximum expiratory pressure (MEP)
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
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
forced vital capacity (FVC)
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.
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
forced expiratory capacity in 1 second (FEV1)
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.
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
maximum voluntary ventilation (MVV)
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
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
vital capacity (VC)
Evaluation of vital capacity (VC) in in Liters (L).
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
red blood cells (RBC)
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).
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
Hemoglobin (Hb)
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).
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
hematocrit (Hct)
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 (%).
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
reticulocytes (RET)
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 (%).
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
erythropoietin (EPO)
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).
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
Fran WOD
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).
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
CrossFit® Total
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).
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
Plan to share: No
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