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临床试验/NCT06105450
NCT06105450已完成不适用

Potential Role of Diaphragmatic Muscle Weakness as a Cause of Persistent Exertional Dyspnea in Patients With COVID-19 Disease Without Hospitalization

RWTH Aachen University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots

研究概览

简要总结

Fatigue and exercise intolerance after survived COVID-19-infection might be related to weakness of the respiratory muscles. The aim of the project is to measure respiratory muscle function and strength in our respiratory physiology laboratory in patients who were not hospitalized during the acute COVID-19-infection but still complain of different persistent symptoms including exertional dyspnea and fatigue.

详细描述

Since the beginning of the COVID pandemic, more and more recovered patients have a number of persistent symptoms including exertional dyspnea and fatigue even months after recovering from acute coronavirus disease 2019 (COVID-19). These symptoms often cannot be explained because routine clinical diagnoses, including extensive cardiac and pulmonary examinations, do not reveal any relevant abnormalities.

In our previous study (Regmi et al) with 50 patients formerly hospitalized due to acute COVID-19 infection, it was shown that diaphragm muscle weakness contributes to persistent exertional dyspnea about one year after hospitalization for COVID-19, regardless of mechanical ventilation. Additionally, the severity of exertional dyspnea correlated with the extent of diaphragmatic weakness.

Since laboratory findings, pulmonary function tests and cardiological routine examinations did not reveal any significant impairments, this was the first time that a potential pathophysiological correlate is objectively associated with dyspnea in long COVID-19 syndrome. The results of our study were clinically relevant because the persistent symptom burden in patients after surviving COVID-19 infection remains very high. In addition diaphragm training presents itself as a potential therapeutic target, since in other diseases such as COPD, such training has been shown to improve the symptoms. Therefore, the investigators believe that the results provide important perspectives, both for the pathophysiological understanding and for the potential treatment of persistent exertional dyspnea in patients.

However, a considerable gap exists here: a significant number of patients who suffer from an acute COVID-19 infection but do not have a severe course during the initial infection, so that hospitalization is not necessary, still complain of different persistent symptoms. Here, too, despite an extensive cardiopulmonary work-up, there is a lack of a sufficient explanation of the lasting complaints. It is precisely in these patients that a possible role of diaphragmatic weakness on the symptoms is yet to be investigated using already established gold standard techniques.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with COVID-19 infection without hospitalization during the acute infection (n=25)
  • Patients aged at least 18 years, who are mentally and physically able to consent and participate into the study

排除标准

  • Clinically pre-established cardiovascular disease or other pulmonary diseases which might lead to exertional dyspnea (systolic heart failure, COPD).
  • Body-mass-index (BMI) >40
  • Expected absence of active participation of the patient in study-related measurements
  • Alcohol or drug abuse
  • Metal implant in the body that is not MRI compatible (NON MRI compatible pacemaker, implantable defibrillator, cervical implants, e.g. brain pacemakers etc.)
  • Slipped disc
  • Bound to a wheel chair

结局指标

主要结局

Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots

时间窗: 1 year

Recording of twitch transdiaphragmatic pressure (Unit: Pressure in cmH2O)

Respiratory mouth pressures

时间窗: 1 year

Measurement of respiratory (inspiratory and expiratory) mouth pressures (Unit: Pressure in cmH2O)

次要结局

  • Exercise intolerance(1 year)
  • EMG(1 year)
  • Diaphragm ultrasound(1 year)
  • Lung function(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jens Spießhöfer

Principal Investigator

RWTH Aachen University

研究点 (1)

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