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

NCT06806124 | Completed

• 1 other identifier: PI 19-1361
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• maximum inspiratory pressure (MIP)

  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.

  First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

• maximum expiratory pressure (MEP)

  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

  First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

Secondary Outcomes (9)

• forced vital capacity (FVC)

  First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

• 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)]

• maximum voluntary ventilation (MVV)

  First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

• vital capacity (VC)

  First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

• red blood cells (RBC)

  First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

Other Outcomes (2)

• Fran WOD

  First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

• CrossFit® Total

  First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

Study Arms (2)

Elevation Training Mask (ETM) Group

EXPERIMENTAL

Elevation Training Mask (ETM) using the corresponding air restriction openings and filters. The first week, the additional altitude simulation was 914 m and the second, 1,829 m. These initial 2 weeks served to familiarize to 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 included) the simulated altitude was 2,743 m, and for weeks 7-12 (both included), the ETM was set to simulate 3,658 m altitude.

Device: Elevation Training Mask

Control Group

SHAM COMPARATOR

For the Control Group, the Elevation Training Mask (ETM) was used for 12 weeks with the largest openings available and without using the air restriction filters, so that there was little respiratory obstruction but the reduction in air flow was minimal, with the aim of having a simulated ETM treatment.

Device: Sham Elevation Training Mask

Interventions

Elevation Training Mask DEVICE

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.

Also known as: Experimental Group

Elevation Training Mask (ETM) Group

Sham Elevation Training Mask DEVICE

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

Also known as: Control Group

Control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: volunteer male CrossFit® athletes
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valladolid: lead

Study Sites (1)

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

Soria, Soria, 42005, Spain

Location

Related Publications (1)

• Fernandez-Lazaro D, Seco-Calvo J, Santamaria G, Donoso DJ, Roche E, Garrosa M. Twelve weeks of respiratory muscle training enhance respiratory function in CrossFit(R) athletes returning to exercise post-SARS-CoV-2 infection: single-blind randomized clinical trial. BMC Sports Sci Med Rehabil. 2025 Aug 14;17(1):236. doi: 10.1186/s13102-025-01261-9.

  PMID: 40814059 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Diego Fernández Lázaro, Vice Dean and Professor

  Faculty of Health Sciences, University of Valladolid, Soria Campus (Spain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Researcher

Model Details: 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

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: February 3, 2025
• Study Start: January 6, 2022
• Primary Completion: December 22, 2022
• Study Completion: December 30, 2023
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)