COVID-19 Clinical Trial
Official title:
Respiratory Muscles After Inspiratory Muscle Training in Patients After COVID-19 With Persistent Dyspnea and Respiratory Muscle Dysfunction
Verified date | May 2023 |
Source | RWTH Aachen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | April 1, 2023 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 - Epilepsy |
Country | Name | City | State |
---|---|---|---|
Germany | RWTH Aachen University | Aachen |
Lead Sponsor | Collaborator |
---|---|
RWTH Aachen University | Philipps University Marburg Medical Center |
Germany,
Balfanz P, Hartmann B, Muller-Wieland D, Kleines M, Hackl D, Kossack N, Kersten A, Cornelissen C, Muller T, Daher A, Stohr R, Bickenbach J, Marx G, Marx N, Dreher M. Early risk markers for severe clinical course and fatal outcome in German patients with COVID-19. PLoS One. 2021 Jan 29;16(1):e0246182. doi: 10.1371/journal.pone.0246182. eCollection 2021. — View Citation
Daher A, Balfanz P, Aetou M, Hartmann B, Muller-Wieland D, Muller T, Marx N, Dreher M, Cornelissen CG. Clinical course of COVID-19 patients needing supplemental oxygen outside the intensive care unit. Sci Rep. 2021 Jan 26;11(1):2256. doi: 10.1038/s41598-021-81444-9. — View Citation
Daher A, Balfanz P, Cornelissen C, Muller A, Bergs I, Marx N, Muller-Wieland D, Hartmann B, Dreher M, Muller T. Follow up of patients with severe coronavirus disease 2019 (COVID-19): Pulmonary and extrapulmonary disease sequelae. Respir Med. 2020 Nov-Dec;174:106197. doi: 10.1016/j.rmed.2020.106197. Epub 2020 Oct 20. — View Citation
Spiesshoefer J, Friedrich J, Regmi B, Geppert J, Jorn B, Kersten A, Giannoni A, Boentert M, Marx G, Marx N, Daher A, Dreher M. Diaphragm dysfunction as a potential determinant of dyspnea on exertion in patients 1 year after COVID-19-related ARDS. Respir Res. 2022 Jul 15;23(1):187. doi: 10.1186/s12931-022-02100-y. — View Citation
Spiesshoefer J, Henke C, Herkenrath S, Brix T, Randerath W, Young P, Boentert M. Transdiapragmatic pressure and contractile properties of the diaphragm following magnetic stimulation. Respir Physiol Neurobiol. 2019 Aug;266:47-53. doi: 10.1016/j.resp.2019. — View Citation
Spiesshoefer J, Henke C, Herkenrath S, Randerath W, Brix T, Young P, Boentert M. Assessment of Central Drive to the Diaphragm by Twitch Interpolation: Normal Values, Theoretical Considerations, and Future Directions. Respiration. 2019;98(4):283-293. doi: — View Citation
Spiesshoefer J, Herkenrath S, Henke C, Langenbruch L, Schneppe M, Randerath W, Young P, Brix T, Boentert M. Evaluation of Respiratory Muscle Strength and Diaphragm Ultrasound: Normative Values, Theoretical Considerations, and Practical Recommendations. Re — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O) | Assessed at baseline | ||
Primary | Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O) | Assessed after 6 weeks of IMT | ||
Primary | Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O) | Assessed 6 weeks after IMT | ||
Primary | Respiratory mouth pressures | Measurement of respiratory (inspiratory and expiratory) mouth pressures (Unit: Pressure in cmH2O) | Assessed at baseline | |
Primary | Respiratory mouth pressures | Measurement of respiratory (inspiratory and expiratory) mouth pressures (Unit: Pressure in cmH2O) | Assessed after 6 weeks of IMT | |
Primary | Respiratory mouth pressures | Measurement of respiratory (inspiratory and expiratory) mouth pressures (Unit: Pressure in cmH2O) | Assessed 6 weeks after IMT | |
Secondary | Diaphragm and Intercostal ultrasound | Thickening fraction (Unit: %) | Assessed at baseline | |
Secondary | Diaphragm and Intercostal ultrasound | Thickening fraction (Unit: %) | Assessed after 6 weeks of IMT | |
Secondary | Diaphragm and Intercostal ultrasound | Thickening fraction (Unit: %) | Assessed 6 weeks after IMT | |
Secondary | Exercise intolerance | Dyspnea (Borg dyspnea scale; Unit 1-10 with higher values indicating more severe dyspnea) | Assessed at baseline | |
Secondary | Exercise intolerance | Dyspnea (Borg dyspnea scale; Unit 1-10 with higher values indicating more severe dyspnea) | Assessed after 6 weeks of IMT | |
Secondary | Exercise intolerance | Dyspnea (Borg dyspnea scale; Unit 1-10 with higher values indicating more severe dyspnea) | Assessed 6 weeks after IMT | |
Secondary | Lung function | Comprehensive assessment of lung function (most importantly forced vital capacity; Unit Liters) | Assessed at baseline | |
Secondary | Lung function | Comprehensive assessment of lung function (most importantly forced vital capacity; Unit Liters) | Assessed after 6 weeks of IMT | |
Secondary | Lung function | Comprehensive assessment of lung function (most importantly forced vital capacity; Unit Liters) | Assessed 6 weeks after IMT | |
Secondary | Electromyography of diaphragm and accessory respiratory muscle activity | Activity of the respiratory muscles (Unit: % with higher values indicating higher activity of the respiratory muscles) | Assessed at baseline | |
Secondary | Electromyography of diaphragm and accessory respiratory muscle activity | Activity of the respiratory muscles (Unit: % with higher values indicating higher activity of the respiratory muscles) | Assessed after 6 weeks of IMT | |
Secondary | Electromyography of diaphragm and accessory respiratory muscle activity | Activity of the respiratory muscles (Unit: % with higher values indicating higher activity of the respiratory muscles) | Assessed 6 weeks after IMT |
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