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临床试验/NCT05323760
NCT05323760Unknown不适用

Functional Capacity in Patients Who Recovered From Mild COVID-19 With Exertional Dyspnea.

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Exercise capacity

研究概览

简要总结

Patients recovered from mild coronavirus 2019 (COVID-19) disease without pulmonary involvement may experience long-term physical impairment and dyspnea. The investigators aim to characterize physiologic limitations in patients who recovered from mild COVID-19.

Methods: Pulmonary function tests (PFTs), 6-minute walk test (6MWT), echocardiography and cardiopulmonary exercise test (CPET) will be completed in patients recovered from mild COVID-19 disease with prolonged dyspnea (Subgroup "A") and compared to patients recovered from moderate/severe COVID-19 (subgroup "B") and to non-COVID-19 patients with unexplained dyspnea (subgroup "C").

详细描述

Infection with severe acute respiratory syndrome coronavirus-2 leads to severe disease requiring hospitalization in 20% of the cases. Respiratory failure from severe acute respiratory syndrome coronavirus-2 infection can range from mild pneumonia and hypoxia to life threatening hypoxia secondary to severe acute respiratory distress syndrome requiring intensive care unit and mechanical ventilation in about 12-24% of the hospitalized patients. Most patients are discharged with minimal or no long-term oxygen therapy while others are discharged with ongoing respiratory symptoms and long-term oxygen therapy. In the longer term, there is a significant concern that severe coronavirus disease 2019 can lead to organizing pneumonia and severe acute lung injury with evolution to widespread fibrotic changes as seen in fatal cases of coronavirus disease showing pulmonary fibrosis at autopsy. Studies in severe acute respiratory syndrome survivors, another corona virus infection, showed persistent and significant impairment of exercise capacity and health status over 24 months based on PFTs, 6-minute walk test and health questionnaire. Infection with respiratory syndrome coronavirus-2 has been also associated with multiple direct and indirect cardiovascular complications including acute myocardial injury, myocarditis, arrhythmias, and venous thromboembolism. However, long term cardiovascular consequences from coronavirus disease 2019 are still unknown. The investigators sought to determine the pulmonary, cardiac and other physiologic limitations in patients who recovered from severe coronavirus disease 2019 with physiologic tests including PFTs, echocardiography and cardio-pulmonary exercise test which is currently the most comprehensive physiologic test that can differentiate between the different limitations and add novel data regarding short and long term physiologic consequences of coronavirus disease 2019.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients recovering from COVID-19 with a documented infection with severe acute respiratory syndrome coronavirus-2 and cognitive ability to sign informed consent and physical ability to participate in exercise tests.

排除标准

  • •Patients with severe pulmonary, cardiac disease prior to COVID-19, pregnant women, and patients with active infection or cancer.

研究组 & 干预措施

Cardiopulmonary exercise test (CPET)

Experimental

Cardiopulmonary exercise testing (CPET) using a Quark CPET metabolic cart (Rome, Italy) according to American Thoracic Society (ATS) guidelines. A symptom-limited test on a treadmill will be performed, using incremental ramp Bruce protocol up to exhaustion. Patients who will not be able to perform the test on a treadmill will be tested on a cycle ergometer beginning with a no-resistance warm-up lasting 2-3 minutes, followed by incrementing resistance (8-30 Watts/minute) adapted to the patient's functional capacities according to the examiner's free judgment, up to exhaustion.

干预措施: Cardiopulmonary exercise test (CPET) (Device)

结局指标

主要结局

Exercise capacity

时间窗: Measured continuously during 15 minutes of the exercise test (CPET)

Oxygen uptake evaluated by cardiopulmonary exercise testing (CPET)

次要结局

  • Echocardiography(Ten minutes)
  • Six minute walk test(Six minutes of evaluation, completed pre cardiopulmonary exercise test.)
  • Spirometry(Five minutes before and after the cardiopulmonary exercise testing)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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