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临床试验/NCT05967039
NCT05967039进行中(未招募)不适用

Evaluation of Lung Function, Lung Ultrasound and Functional Capacity in Long-COVID Patients Who Underwent Physical Therapy

Centro Universitário Augusto Motta2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2022年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
65
试验地点
2
主要终点
Six-minute walk test coupled into the measurement of pulmonary ventilation

研究概览

简要总结

A paucity of prognostic studies in patients with post-COVID-19 syndrome (long-COVID) shows the need to identify the main effects on functional capacity in the short and medium term. In this regard, the evaluation of lung function, lung structure and functional capacity in long-COVID patients is essential to estimate the impact of the disease. This retrospective observational study aims to compare functional capacity, lung function, and lung ultrasound findings in patients who underwent physical therapy to those who did not.

详细描述

Introduction

The pandemic caused by the Severe acute respiratory syndrome by coronavirus 2 (SARS-CoV-2) has been presented as a one of the greatest health challenges on a global scale at the beginning of this millennium. Many patients need physical therapy in their recovery process. A paucity of prognostic studies in patients with long-COVID shows the need to identify the main repercussions on functional capacity in the short and medium term. In this regard, the evaluation of lung function, lung structure and functional capacity in long-COVID patients is essential to estimate the impact of the disease.

Objective

The present study aims to compare functional capacity, lung function, and lung ultrasound findings between patients diagnosed with long-COVID who underwent physical therapy to those who did not.

Methods: This is a retrospective observational study with quantitative data analysis. The study will be carried out at the Pulmonary Function Laboratory of the Policlínica Universitária Piquet Carneiro, from the State University of Rio de Janeiro. First, a clinical evaluation will be performed. In the survey, it will be asked whether the patient had undergone physical therapy treatment, so they can be allocated in the control or intervention group. After that, they will answer to the Post-COVID-19 Functional Status Scale (PCFS), a tool to measure functional status over time after COVID-19. Then, patients will have their lung function evaluated through spirometry and impulse oscillometry (IOS). In addition, lung ultrasound (LUS) images will be analyzed. And their functional capacity will be assessed using the six-minute walk test (6MWT) coupled to pulmonary ventilation measurement using Spiropalm® (Spiropalm 6MWT, Cosmed, Rome, Italy).

It is expected that understanding the consequences of long-COVID on pulmonary ventilation can help to design therapeutic strategies in rehabilitation services.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals with an established diagnosis of COVID-19 (RT-PCR) who required hospitalization or not, regardless of whether or not they were treated in the ICU.

排除标准

  • Patients unable to perform the tests. Patients with musculoskeletal disorders not associated with COVID-
  • Patients with lung, heart or cerebrovascular diseases not associated with COVID-19.

结局指标

主要结局

Six-minute walk test coupled into the measurement of pulmonary ventilation

时间窗: October 2023

The individuals will undergo the six-minute walk test coupled to the measurement of ventilation using equipment using a face mask with monitoring of ventilatory variables and vital signs on a 30-meter track where the purpose is to assess the functional capacity

次要结局

  • Functional Status scale PCFS(October 2023)
  • Spirometry(October 2023)
  • Impulse oscillometry(October 2023)
  • Lung ultrasound(October 2023)

研究者

发起方
Centro Universitário Augusto Motta
申办方类型
Other
责任方
Sponsor

研究点 (2)

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