NCT06806124

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Valladolid · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2022-01-06
• Primary completion: 2022-12-22
• Completion: 2023-12-30
• First posted: 2025-02-03
• Last updated: 2025-02-05

Locations

1 site across 1 country: Spain