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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- maximum inspiratory pressure (MIP)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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-
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
Elevation Training Mask (ETM) Group
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.
干预措施: Elevation Training Mask (Device)
Control Group
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.
干预措施: Sham Elevation Training Mask (Device)
结局指标
主要结局
maximum inspiratory pressure (MIP)
时间窗: 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)
时间窗: 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
次要结局
- red blood cells (RBC)(First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)])
- 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)])
- Hemoglobin (Hb)(First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)])
- hematocrit (Hct)(First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)])
- reticulocytes (RET)(First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)])
- erythropoietin (EPO)(First day of study and after 12 weeks of Elevation Training Mask 2.0 use (end of study)])
研究者
Diego Fernández Lázaro
Professor and Researcher
University of Valladolid