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

University of Valladolid (UVA)

Status: Completed

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

Treatments: Device: Elevation Training Mask; Device: Sham Elevation Training Mask

Study type: Interventional

Funder types: Other

Identifiers

NCT06806124

PI 19-1361

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Elevation Training Mask (ETM) Group

Experimental group

Description:

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.

Treatment:

Device: Elevation Training Mask

Control Group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Elevation Training Mask