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

Not Applicable

Completed

• Conditions: COVID19- Infection with SARS-CoV-2 Virus; SARS-CoV-2 Positive Patients; COVID-19 Pulmonary Complications; SARS-CoV-2 Infection (Symptomatic)

• Registration Number: NCT06806124
• Lead Sponsor: University of Valladolid

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-06
• Primary Completion: 2022-12-22
• Study Completion: 2023-12-30
• Study First Submitted: 2025-01-25
• Study First Submitted QC: 2025-01-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-02
• Study First Posted: 2025-02-03
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
maximum inspiratory pressure (MIP)	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.
maximum expiratory pressure (MEP)	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 Outcome Measures

Name	Time	Method
forced vital capacity (FVC)	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.
forced expiratory capacity in 1 second (FEV1)	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.
maximum voluntary ventilation (MVV)	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
vital capacity (VC)	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).
red blood cells (RBC)	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).
Hemoglobin (Hb)	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).
hematocrit (Hct)	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 (%).
reticulocytes (RET)	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 (%).
erythropoietin (EPO)	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).

Trial Locations

Locations (1)

Department of Cell Biology, Genetics, Histology and Pharmacology of the University of Valladolid; 🇪🇸 Soria, Spain