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肺康复联合无创通气对新冠后身体能力和生活质量的影响:一项随机对照双盲临床试验方案

Pulmonary Rehabilitation Associated with Noninvasive Ventilation on Physical Capacity and Quality of Life in Post-COVID-19: A Randomized Controlled Double-Blinded Clinical Trial Protocol.

作者信息

Arêas Guilherme Peixoto Tinoco, Goulart Cássia da Luz, Sant'Anna Thaís, Fernandes Tiótrefis Gomes, Alvim Rafael de Oliveira, Borges Fernanda Facioli Dos Reis, do Amaral Camila Miriam Suemi Sato Barros, Rodrigues Suzy Cristina França, Valente Jefferson, Ferreira João Marcos Bemfica Barbosa, Rezende Anna Gabriela, de Oliveira Júnior Edival Ferreira, de Lacerda Marcus Vinícius Guimarães, de Almeida-Val Fernando Fonseca

机构信息

Department of Physiological Sciences, Exercise Physiology Laboratory, Federal University of Amazonas, Manaus, AM, Brasil.

Cardiopulmonary Laboratory, Getúlio Vargas University Hospital, UFAM, Manaus, AM, Brasil.

出版信息

J Multidiscip Healthc. 2024 Apr 5;17:1483-1490. doi: 10.2147/JMDH.S438120. eCollection 2024.

DOI:10.2147/JMDH.S438120
PMID:38596000
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11003467/
Abstract

BACKGROUND

The coronavirus disease-2019 (COVID-19) pulmonary rehabilitation (PR) seems to be a better choice to improve physical and functional capacity after acute infection. However, there is a lack of evidence regarding the effects of different strategies to optimize post-acute phase rehabilitation and reduce long COVID-19 physical deteriorations.

OBJECTIVE

To compare the use of a noninvasive ventilation (NIV) plus aerobic exercise strategy during PR program with to a standard PR (without NIV) on physical capacity and quality of life outcomes in post-COVID-19.

METHODS

Double-blinded randomized controlled clinical trial. A total of 100 individuals discharged from hospital in a post-acute phase of severe COVID-19 will be randomized into two groups: PR + NIV (Group 1) and PR (Group 2). Inclusion criteria include participants who present symptomatic dyspnea II and III by the modified Medical Research Council, aged 18 years or older. Both groups will receive aerobic and resistance exercise, and inspiratory muscle training. However, group 1 will perform aerobic training with bilevel NIV. Cardiopulmonary exercise test will assess the O peak uptake, 6-minute walk test will assess the walking distance and short-form 36 will assess the quality of life before and after 8 weeks (after 24 PR sessions). Moreover, patients will be contacted by telephone every 3 months for one year to record possible adverse events, hospitalizations, and death. All data will be registered in RedCap, and analyses will be performed in the STATA v13 software.

CLINICAL TRIAL REGISTRATION

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摘要

背景

2019冠状病毒病(COVID-19)肺康复(PR)似乎是改善急性感染后身体和功能能力的更好选择。然而,关于优化急性后期康复和减少COVID-19长期身体恶化的不同策略的效果,目前缺乏证据。

目的

比较肺康复计划中无创通气(NIV)加有氧运动策略与标准肺康复(无NIV)对COVID-19后身体能力和生活质量结果的影响。

方法

双盲随机对照临床试验。总共100名在严重COVID-19急性后期出院的个体将被随机分为两组:PR + NIV(第1组)和PR(第2组)。纳入标准包括根据改良医学研究委员会评定为有II级和III级症状性呼吸困难的参与者,年龄在18岁及以上。两组都将接受有氧运动、抗阻运动和吸气肌训练。然而,第1组将使用双水平NIV进行有氧运动训练。心肺运动试验将评估峰值摄氧量,6分钟步行试验将评估步行距离,简短健康调查问卷36项版本将评估8周后(24次肺康复治疗后)的生活质量。此外,将在一年中每3个月通过电话联系患者,记录可能的不良事件、住院情况和死亡情况。所有数据将记录在RedCap中,并在STATA v13软件中进行分析。

临床试验注册

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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82b5/11003467/98bc4b76dd0a/JMDH-17-1483-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82b5/11003467/98bc4b76dd0a/JMDH-17-1483-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82b5/11003467/98bc4b76dd0a/JMDH-17-1483-g0001.jpg

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COVID-19 seen from a syndemic perspective: Impact of unhealthy habits and future perspectives to combat these negative interactions in Latin America.从综合征角度看 COVID-19:不健康习惯的影响及拉丁美洲对抗这些负面相互作用的未来展望。
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Can Non-invasive Ventilation Modulate Cerebral, Respiratory, and Peripheral Muscle Oxygenation During High-Intensity Exercise in Patients With COPD-HF?
在慢性阻塞性肺疾病合并心力衰竭(COPD-HF)患者进行高强度运动期间,无创通气能否调节大脑、呼吸及外周肌肉的氧合作用?
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Lifestyle and rehabilitation during the COVID-19 pandemic: guidance for health professionals and support for exercise and rehabilitation programs.COVID-19 大流行期间的生活方式和康复:卫生专业人员指南以及对运动和康复计划的支持。
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