Clinical trial NCT06806124: Impact of the Elevation Training Mask in CrossFit® Post-SARS-CoV-2 Infection.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID19- Infection with SARS-CoV-2 Virus
SARS-CoV-2 Positive Patients
COVID-19 Pulmonary Complications
SARS-CoV-2 Infection (Symptomatic)
Keywords: Elevation Training Mask
SARS-CoV-2
CrossFit®
Spirometric Parameters
Hematological Biomarkers
WOD
Lead sponsor: University of Valladolid
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 The Elevation Training Mask (ETM) 2.0 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
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: maximum inspiratory pressure (MIP)
timeFrame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
measure: maximum expiratory pressure (MEP)
timeFrame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
Secondary outcomes:
measure: forced vital capacity (FVC)
timeFrame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
measure: forced expiratory capacity in 1 second (FEV1)
timeFrame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
measure: maximum voluntary ventilation (MVV)
timeFrame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
measure: vital capacity (VC)
timeFrame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
measure: red blood cells (RBC)
timeFrame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
measure: Hemoglobin (Hb)
timeFrame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
measure: hematocrit (Hct)
timeFrame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
measure: reticulocytes (RET)
timeFrame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
measure: erythropoietin (EPO)
timeFrame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
Other outcomes:
measure: Fran WOD
timeFrame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
measure: CrossFit® Total
timeFrame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
Locations:
city: Soria
country: Spain
facility: Department of Cell Biology, Genetics, Histology and Pharmacology of the University of Valladolid
Study officials:
affiliation: Faculty of Health Sciences, University of Valladolid, Soria Campus (Spain)
name: Diego Fernández Lázaro, Vice Dean and Professor
role: PRINCIPAL_INVESTIGATOR
References: