Respiratory Muscles After Inspiratory Muscle Training in Patients After COVID-19 With Persistent Dyspnea and Respiratory Muscle Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)
研究概览
简要总结
It is the aim of the current (follow-up) project for the first time in post-COVID-19 patients who continue to complain of shortness of breath and for whom there is no other explanation than possibly proven diaphragmatic weakness, to determine the effects of 6 weeks of IMT/diaphragm training on diaphragm strength and shortness of breath.
详细描述
Breathing is a complex process involving muscular, neurological and chemical processes in the body. Herein, the respiratory muscles play a very important role.
The respiratory muscles are the muscle groups that cause the expansion and contraction of the chest during inhalation and exhalation. The most important respiratory muscle is the diaphragm. It is known that long-term ventilation in the intensive care unit weakens the respiratory muscles, since the work of the muscles is taken over by the ventilation devices and the muscles are not trained over a long period of time.
As recently shown, COVID-19 disease can lead to diaphragmatic weakness even in the absence of ventilation.
In this project (CTCA 20-515) the present investigators demonstrated that several patients after COVID-19 suffer from diaphragmatic weakness. Specifically, diaphragmatic weakness also related to shortness of breath complained about by patients and currently not otherwise explainable.
The so-called inspiratory muscle training (IMT or diaphragm training) is known in pneumological rehabilitation for years. In the current project, after the training has been explained, the patient is asked to breathe against resistance at home using a small mouthpiece and a small device several times (twice) a day and several times a week (each day).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •18 patients with survived COVID-19, persistent otherwise unexplainable dyspnoea and proven diaphragm dysfunction
- •Patients aged at least 18 years, who are mentally and physically able to consent and participate into the study
排除标准
- •Diagnosis of another disease, which causes a permanent increase in carbon dioxide level in the blood (chronic hypercapnia) or a permanent combined lung weakness (particularly a neuromuscular disease)
- •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
研究组 & 干预措施
Diaphragm Strength Training
干预措施: Inspiratory Muscle Training (IMT) (Device)
Diaphragm Endurance Training
干预措施: Inspiratory Muscle Training (IMT) (Device)
结局指标
主要结局
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)
时间窗: Assessed 6 weeks after IMT
Respiratory mouth pressures
时间窗: Assessed 6 weeks after IMT
Measurement of respiratory (inspiratory and expiratory) mouth pressures (Unit: Pressure in cmH2O)
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)
时间窗: Assessed at baseline
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)
时间窗: Assessed after 6 weeks of IMT
Respiratory mouth pressures
时间窗: Assessed at baseline
Measurement of respiratory (inspiratory and expiratory) mouth pressures (Unit: Pressure in cmH2O)
Respiratory mouth pressures
时间窗: Assessed after 6 weeks of IMT
Measurement of respiratory (inspiratory and expiratory) mouth pressures (Unit: Pressure in cmH2O)
次要结局
- Lung function(Assessed 6 weeks after IMT)
- Electromyography of diaphragm and accessory respiratory muscle activity(Assessed 6 weeks after IMT)
- Exercise intolerance(Assessed 6 weeks after IMT)
- Diaphragm and Intercostal ultrasound(Assessed 6 weeks after IMT)
- Diaphragm and Intercostal ultrasound(Assessed at baseline)
- Diaphragm and Intercostal ultrasound(Assessed after 6 weeks of IMT)
- Exercise intolerance(Assessed at baseline)
- Exercise intolerance(Assessed after 6 weeks of IMT)
- Lung function(Assessed at baseline)
- Lung function(Assessed after 6 weeks of IMT)
- Electromyography of diaphragm and accessory respiratory muscle activity(Assessed at baseline)
- Electromyography of diaphragm and accessory respiratory muscle activity(Assessed after 6 weeks of IMT)
研究者
Jens Spießhöfer
Principal Investigator
RWTH Aachen University