COVID19- Infection with SARS-CoV-2 VirusETMEXCOVIDNCT06806124

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

A study testing Elevation Training Mask in people with COVID19- Infection with SARS-CoV-2 Virus and SARS-CoV-2 Positive Patients, run by University of Valladolid at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: COVID19- Infection with SARS-CoV-2 Virus, SARS-CoV-2 Positive Patients, COVID-19 Pulmonary Complications
What is being tested?: Elevation Training Mask
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteSpain
Study dates: 6 Jan 2022to 30 Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Show all 9Show fewer

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

Spain1 site

Department of Cell Biology, Genetics, Histology and Pharmacology of the University of Valladolid
Soria, Soria, 42005

Other trials in Spain

About this study

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.

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)
Being tested: Elevation Training Mask, Sham Elevation Training Mask
Keywords: Elevation Training Mask, SARS-CoV-2, CrossFit®, Spirometric Parameters, Hematological Biomarkers, WOD
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Elevation Training MaskDevice
Also called Experimental Group
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.
Sham Elevation Training MaskDevice
Also called Control Group
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

Study groups in NCT06806124
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Sham Elevation Training Mask

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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)
Evaluation of Forced vital capacity (FVC) in Liters (L). FVC is a pulmonary function measurement that represents the total amount of air a person can forcibly exhale from their lungs after taking the deepest breath possible.
Measured: 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)
Evaluation of forced expiratory capacity in 1 second (FEV1) in Liters (L). FEV1 indicates the volume of air a person can forcefully exhale in one second.
Measured: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
maximum voluntary ventilation (MVV)
Evaluation of Maximal Voluntary Ventilation (MVV) in Liters / minute (L/min). MVV is a measure of the maximum amount of air a person can breathe in and out within a specific time frame, typically one minute
Measured: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
vital capacity (VC)
Evaluation of vital capacity (VC) in in Liters (L).
Measured: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
red blood cells (RBC)
Erythrocytes, red blood cells (RBC), are the functional components of blood responsible for transporting gases and nutrients throughout the human body. Evaluation of RBC million / microliter (mill/µL).
Measured: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
Hemoglobin (Hb)
Hemoglobin (Hb) is the protein molecule in red blood cells that carries oxygen from the lungs to the body's tissues and returns carbon dioxide from the tissues back to the lungs. Hgb is made up of four protein molecules (globulin chains) that are connected. Evaluation of Hb in grams / deciliter (g/dL).
Measured: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
hematocrit (Hct)
A hematocrit test (Hct) is a simple blood test that measures the percentage of red blood cells in your blood. Evaluation of Hct in Percentage (%).
Measured: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
reticulocytes (RET)
Reticulocytes are immature red blood cells (RBCs) produced in the bone marrow and released into the peripheral blood, where they mature into RBCs within 1 to 2 days. Evaluation of Reticulocytes in Percentage (%).
Measured: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
erythropoietin (EPO)
Erythropoietin (EPO) is a hormone that regulates the production of red blood cells. It is produced by kidney cells in response to low oxygen levels in the tissues. EPO promotes the formation of red blood cells by the bone marrow. EPO deficiency can result in reduced production of red blood cells, leading to anemia. EPO is also known as eritropoyetina or hemopoyetina. Evaluation of EPO in milliunits/milliliter (mU/mL).
Measured: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 202230 Dec 2023

First posted3 Feb 2025
Study start6 Jan 2022
Primary completion22 Dec 2022
Study completion30 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID19- Infection with SARS-CoV-2 VirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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
Masking: Single blind
Who is masked: Participant
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06806124
Sponsor's protocol ID: PI 19-1361
Acronym: ETMEXCOVID
Status last verified: Feb 2025
First submitted: 25 Jan 2025
Last updated: 5 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40814059

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT06806124
Acronym / sponsor ID: ETMEXCOVID / PI 19-1361
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University of ValladolidUniversity, hospital or other
Study start: 6 Jan 2022 (actual)
Primary completion: 22 Dec 2022 (actual)
Study completion: 30 Dec 2023 (actual)
First posted: 3 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
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

Arm	Type	Receives
Elevation Training Mask (ETM) Group	Experimental	Device: Elevation Training MaskElevation 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.
Control Group	Sham comparator	Device: Sham Elevation Training MaskFor 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.

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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®.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Elevation Training MaskAlso: Experimental GroupThe 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	Elevation Training Mask (ETM) Group
Sham Elevation Training MaskAlso: Control GroupFor 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	Device	Control Group

Primary outcome

maximum inspiratory pressure (MIP)
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
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.
maximum expiratory pressure (MEP)
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
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

9 secondary outcomes

forced vital capacity (FVC)
Time frame: 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)
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
maximum voluntary ventilation (MVV)
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
vital capacity (VC)
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
red blood cells (RBC)
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
Hemoglobin (Hb)
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
hematocrit (Hct)
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
reticulocytes (RET)
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]
erythropoietin (EPO)
Time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
Derived from this study: PubMed 40814059Fernandez-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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Diego Fernández Lázaro, Vice Dean and Professor principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Elevation Training Mask in people with COVID19- Infection with SARS-CoV-2 Virus and SARS-CoV-2 Positive Patients, run by University of Valladolid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maximum inspiratory pressure (MIP) (time frame: First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06806124, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.