Official 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.
Brief Summary

Introduction: The Elevation Training Mask (ETM) could restore respiratory orhematological organic damages from the acute or post-infection phase of severe acuterespiratory syndrome coronavirus 2 (SARSCoV2) because it would allow the application ofhypoxia and respiratory muscle training during exercise. The aim of this study was tocomparatively evaluate the respiratory and hematological parameters and performance ofathletes 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 athleteswere randomly assigned to an experimental group (EG) using the ETM and to a CG using thesimulated ETM, they completed 12 weeks of CrossFit® training after 1 month of thecessation of SARS-CoV-2 symptoms. Pre- and post-training tests included spirometric,hematological, and sports performance assessment.

Detailed Description

Not Provided

Completed
COVID19- Infection With SARS-CoV-2 Virus
SARS-CoV-2 Positive Patients
COVID-19 Pulmonary Complications
SARS-CoV-2 Infection (Symptomatic)

Device: 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.
Other Name: Experimental Group

Device: Sham Elevation Training Mask

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 Name: Control Group

Eligibility Criteria

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.

Eligibility Gender
Male
Eligibility Age
Minimum: 18 Years ~ Maximum: 50 Years
Countries
Spain
Locations

Department of Cell Biology, Genetics, Histology and Pharmacology of the University of Valladolid
Soria 3108681, Soria, Spain

Diego Fernández Lázaro, Vice Dean and Professor, Principal Investigator
Faculty of Health Sciences, University of Valladolid, Soria Campus (Spain)

University of Valladolid
NCT Number
Keywords
Elevation Training Mask
SARS-CoV-2
CrossFit®
Spirometric Parameters
Hematological Biomarkers
WOD
MeSH Terms
COVID-19
Control Groups