Cargando…

Effects of moderate-intensity intermittent hypoxic training on health outcomes of patients recovered from COVID-19: the AEROBICOVID study protocol for a randomized controlled trial

BACKGROUND: Recent studies point to a lower number and reduced severity of cases in higher altitude cities with decreased oxygen concentration. Specific literature has shown several benefits of physical training, so, in this sense, physical training with hypoxic stimulus appears as an alternative th...

Descripción completa

Detalles Bibliográficos
Autores principales: Trapé, Átila Alexandre, Camacho-Cardenosa, Marta, Camacho-Cardenosa, Alba, Merellano-Navarro, Eugenio, Rodrigues, Jhennyfer Aline Lima, da Silva Lizzi, Elisangela Aparecida, Sorgi, Carlos Arterio, Papoti, Marcelo, Brazo-Sayavera, Javier
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8358903/
https://www.ncbi.nlm.nih.gov/pubmed/34384461
http://dx.doi.org/10.1186/s13063-021-05414-2
_version_ 1783737435954348032
author Trapé, Átila Alexandre
Camacho-Cardenosa, Marta
Camacho-Cardenosa, Alba
Merellano-Navarro, Eugenio
Rodrigues, Jhennyfer Aline Lima
da Silva Lizzi, Elisangela Aparecida
Sorgi, Carlos Arterio
Papoti, Marcelo
Brazo-Sayavera, Javier
author_facet Trapé, Átila Alexandre
Camacho-Cardenosa, Marta
Camacho-Cardenosa, Alba
Merellano-Navarro, Eugenio
Rodrigues, Jhennyfer Aline Lima
da Silva Lizzi, Elisangela Aparecida
Sorgi, Carlos Arterio
Papoti, Marcelo
Brazo-Sayavera, Javier
author_sort Trapé, Átila Alexandre
collection PubMed
description BACKGROUND: Recent studies point to a lower number and reduced severity of cases in higher altitude cities with decreased oxygen concentration. Specific literature has shown several benefits of physical training, so, in this sense, physical training with hypoxic stimulus appears as an alternative that supports the conventional treatments of the COVID-19 patient’s recovery. Thus, this study’s primary aim is to analyze the effects of moderate-intensity intermittent hypoxic training on health outcomes in COVID-19 recovered patients. METHODS: A clinical trial controlled double-blind study was designed. Participants (30–69 years old) will be recruited among those with moderate to severe COVID-19 symptoms, approximately 30 days after recovery. They will be included in groups according to the training (T) and recovery (R) association with hypoxia (H) or normoxia (N): (a) T(H):R(H), (b) T(N):R(H), (c) T(N):R(N), and last (d) the control group. The 8-week exercise bike intervention will be carried out with a gradual load increase according to the established periods, three times a week in sets of 5 min, 90 to 100% of the anaerobic threshold (AT), and a 2.5-min break. Blood will be collected for genotyping. First, after 4 weeks (partial), after 8 weeks, and later, 4 weeks after the end of the physical training intervention, participants will perform assessments. The primary outcome is the maximum oxygen consumption (VO(2)peak). The secondary outcomes include lung function, inflammatory mediators, hematological, autonomic parameters, AT, body composition analysis, quality of life, mental health, anthropometric measurements, and physical fitness. The statistical analysis will be executed using the linear regression model with mixed effects at a 5% significance level. DISCUSSION: This study is designed to provide evidence to support the clinical benefits of moderate-intensity intermittent hypoxic training as a part of the treatment of patients recovered from COVID-19. It may also provide evidence on the efficacy and safety of intermittent hypoxic training in different health conditions. Lastly, this study presents an innovative strategy enabling up to 16 participants in the same training session. TRIAL REGISTRATION: ClinicalTrials.gov RBR-5d7hkv. Registered after the start of inclusion on 3 November 2020 with the Brazilian Clinical Trials Registry SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05414-2.
format Online
Article
Text
id pubmed-8358903
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-83589032021-08-12 Effects of moderate-intensity intermittent hypoxic training on health outcomes of patients recovered from COVID-19: the AEROBICOVID study protocol for a randomized controlled trial Trapé, Átila Alexandre Camacho-Cardenosa, Marta Camacho-Cardenosa, Alba Merellano-Navarro, Eugenio Rodrigues, Jhennyfer Aline Lima da Silva Lizzi, Elisangela Aparecida Sorgi, Carlos Arterio Papoti, Marcelo Brazo-Sayavera, Javier Trials Study Protocol BACKGROUND: Recent studies point to a lower number and reduced severity of cases in higher altitude cities with decreased oxygen concentration. Specific literature has shown several benefits of physical training, so, in this sense, physical training with hypoxic stimulus appears as an alternative that supports the conventional treatments of the COVID-19 patient’s recovery. Thus, this study’s primary aim is to analyze the effects of moderate-intensity intermittent hypoxic training on health outcomes in COVID-19 recovered patients. METHODS: A clinical trial controlled double-blind study was designed. Participants (30–69 years old) will be recruited among those with moderate to severe COVID-19 symptoms, approximately 30 days after recovery. They will be included in groups according to the training (T) and recovery (R) association with hypoxia (H) or normoxia (N): (a) T(H):R(H), (b) T(N):R(H), (c) T(N):R(N), and last (d) the control group. The 8-week exercise bike intervention will be carried out with a gradual load increase according to the established periods, three times a week in sets of 5 min, 90 to 100% of the anaerobic threshold (AT), and a 2.5-min break. Blood will be collected for genotyping. First, after 4 weeks (partial), after 8 weeks, and later, 4 weeks after the end of the physical training intervention, participants will perform assessments. The primary outcome is the maximum oxygen consumption (VO(2)peak). The secondary outcomes include lung function, inflammatory mediators, hematological, autonomic parameters, AT, body composition analysis, quality of life, mental health, anthropometric measurements, and physical fitness. The statistical analysis will be executed using the linear regression model with mixed effects at a 5% significance level. DISCUSSION: This study is designed to provide evidence to support the clinical benefits of moderate-intensity intermittent hypoxic training as a part of the treatment of patients recovered from COVID-19. It may also provide evidence on the efficacy and safety of intermittent hypoxic training in different health conditions. Lastly, this study presents an innovative strategy enabling up to 16 participants in the same training session. TRIAL REGISTRATION: ClinicalTrials.gov RBR-5d7hkv. Registered after the start of inclusion on 3 November 2020 with the Brazilian Clinical Trials Registry SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05414-2. BioMed Central 2021-08-12 /pmc/articles/PMC8358903/ /pubmed/34384461 http://dx.doi.org/10.1186/s13063-021-05414-2 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Trapé, Átila Alexandre
Camacho-Cardenosa, Marta
Camacho-Cardenosa, Alba
Merellano-Navarro, Eugenio
Rodrigues, Jhennyfer Aline Lima
da Silva Lizzi, Elisangela Aparecida
Sorgi, Carlos Arterio
Papoti, Marcelo
Brazo-Sayavera, Javier
Effects of moderate-intensity intermittent hypoxic training on health outcomes of patients recovered from COVID-19: the AEROBICOVID study protocol for a randomized controlled trial
title Effects of moderate-intensity intermittent hypoxic training on health outcomes of patients recovered from COVID-19: the AEROBICOVID study protocol for a randomized controlled trial
title_full Effects of moderate-intensity intermittent hypoxic training on health outcomes of patients recovered from COVID-19: the AEROBICOVID study protocol for a randomized controlled trial
title_fullStr Effects of moderate-intensity intermittent hypoxic training on health outcomes of patients recovered from COVID-19: the AEROBICOVID study protocol for a randomized controlled trial
title_full_unstemmed Effects of moderate-intensity intermittent hypoxic training on health outcomes of patients recovered from COVID-19: the AEROBICOVID study protocol for a randomized controlled trial
title_short Effects of moderate-intensity intermittent hypoxic training on health outcomes of patients recovered from COVID-19: the AEROBICOVID study protocol for a randomized controlled trial
title_sort effects of moderate-intensity intermittent hypoxic training on health outcomes of patients recovered from covid-19: the aerobicovid study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8358903/
https://www.ncbi.nlm.nih.gov/pubmed/34384461
http://dx.doi.org/10.1186/s13063-021-05414-2
work_keys_str_mv AT trapeatilaalexandre effectsofmoderateintensityintermittenthypoxictrainingonhealthoutcomesofpatientsrecoveredfromcovid19theaerobicovidstudyprotocolforarandomizedcontrolledtrial
AT camachocardenosamarta effectsofmoderateintensityintermittenthypoxictrainingonhealthoutcomesofpatientsrecoveredfromcovid19theaerobicovidstudyprotocolforarandomizedcontrolledtrial
AT camachocardenosaalba effectsofmoderateintensityintermittenthypoxictrainingonhealthoutcomesofpatientsrecoveredfromcovid19theaerobicovidstudyprotocolforarandomizedcontrolledtrial
AT merellanonavarroeugenio effectsofmoderateintensityintermittenthypoxictrainingonhealthoutcomesofpatientsrecoveredfromcovid19theaerobicovidstudyprotocolforarandomizedcontrolledtrial
AT rodriguesjhennyferalinelima effectsofmoderateintensityintermittenthypoxictrainingonhealthoutcomesofpatientsrecoveredfromcovid19theaerobicovidstudyprotocolforarandomizedcontrolledtrial
AT dasilvalizzielisangelaaparecida effectsofmoderateintensityintermittenthypoxictrainingonhealthoutcomesofpatientsrecoveredfromcovid19theaerobicovidstudyprotocolforarandomizedcontrolledtrial
AT sorgicarlosarterio effectsofmoderateintensityintermittenthypoxictrainingonhealthoutcomesofpatientsrecoveredfromcovid19theaerobicovidstudyprotocolforarandomizedcontrolledtrial
AT papotimarcelo effectsofmoderateintensityintermittenthypoxictrainingonhealthoutcomesofpatientsrecoveredfromcovid19theaerobicovidstudyprotocolforarandomizedcontrolledtrial
AT brazosayaverajavier effectsofmoderateintensityintermittenthypoxictrainingonhealthoutcomesofpatientsrecoveredfromcovid19theaerobicovidstudyprotocolforarandomizedcontrolledtrial