NCT06806124: ETMEXCOVID

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

Completed NA Last updated 5 February 2025

What this trial tests

NA trial testing Elevation Training Mask in COVID19- Infection with SARS-CoV-2 Virus in 20 participants. Completed in 30 December 2023.

Timeline

6 January 2022

Primary endpoint
22 December 2022

30 December 2023

Quick facts

Lead sponsor	University of Valladolid
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	6 January 2022
Primary completion	22 December 2022
Estimated completion	30 December 2023
Sites	1 location across Spain

Drugs / interventions tested

• Elevation Training Mask
• Sham Elevation Training Mask

Conditions studied

• COVID19- Infection with SARS-CoV-2 Virus — all drugs for COVID19- Infection with SARS-CoV-2 Virus →
• SARS-CoV-2 Positive Patients — all drugs for SARS-CoV-2 Positive Patients →
• COVID-19 Pulmonary Complications — all drugs for COVID-19 Pulmonary Complications →
• SARS-CoV-2 Infection (Symptomatic) — all drugs for SARS-CoV-2 Infection (Symptomatic) →

Sponsor

University of Valladolid

Who can join

Adults 18 to 50, male only, with COVID19- Infection with SARS-CoV-2 Virus or SARS-CoV-2 Positive Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Twelve weeks of respiratory muscle training enhance respiratory function in CrossFit<sup>®</sup> athletes returning to exercise post-SARS-CoV-2 infection: single-blind randomized clinical trial.
   Fernández-Lázaro D, Seco-Calvo J, Santamaría G, Donoso DJ, et al · · 2025 · PMID 40814059 · DOI 10.1186/s13102-025-01261-9
2. Analysis of blood biomarkers and sports performance in crossfit athletes using the elevation training mask 2.0 post SARS-CoV-2 infection.
   Jerves-Donoso D, Garrosa M, Garcia-Sierra JF, Santamaría G, et al · · 2025 · PMID 40797088 · DOI 10.1038/s41598-025-14916-x