REMAP-COVID-19
Respiratory Muscle Function After Hospitalisation for COVID-19 -Pathophysiological Model on Severity, Determinants and Clinical Consequences of Respiratory Muscle Strength Impairment in Patients Who Had Been Hospitalised for COVID-19-
Sponsor study identifier
observational
50
1 country
1
Study Start
June 1, 2021
Actual (reported)Primary Completion
July 1, 2023
Actual (reported)Study Completion
November 20, 2024
Actual (reported)Fatigue and exercise intolerance after survived COVID-19-infection might be related to weakness of the respiratory muscles especially following invasive mechanical ventilation in the Intensive Care Unit. The aim of the project is to measure respiratory muscle function and strength in our respiratory physiology laboratory (Respiratory Physiology Laboratory, Department of Pneumology and Intensive Care Medicine, Head: Professor Michael Dreher) in patients who survived a severe COVID-19-infection (25 with a severe course requiring mechanical ventilation in the intensive care unit, 25 with a moderate-severe course requiring administration of supplemental oxygen only, respectively). Based on this data the aim is to develop a model which determines the severity, pathophysiology and clinical consequences of respiratory muscle dysfunction in patients who had been hospitalised for COVID-19. This will potentially prove the importance of a dedicated pulmonologic rehabilitation with respiratory muscle strength training in patients who had been hospitalised for COVID-19.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 20, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 15, 2021
Actual (reported)April 22, 2021
Actual (reported)June 1, 2021
Actual (reported)July 1, 2023
Actual (reported)November 20, 2024
Actual (reported)Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots
Recording of twitch transdiaphragmatic pressure (Unit: Pressure in cmH2O)
2 years
Respiratory mouth pressures
Measurement of respiratory (inspiratory and expiratory) mouth pressures (Unit: Pressure in cmH2O)
2 years
Diaphragm ultrasound
2 years
Exercise intolerance
2 years
Analyses of markers of systemic inflammation (interleukin levels in ng/ml, TNF alpha in ng/ml, CRP in mg/L; immune phenotyping of inflammatory cells, most importantly whilte blood cell subtypes in %)
2 years
Lung function
2 years
Comprehensive assessment of respiratory muscle function to the point of its invasive assessment with recordings of twitch transdiaphragmatic pressure in response to magnetic phrenic nerve stimulation and stimulation of the lower thoracic nerve roots.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The aim of the present project is to comprehensively measure respiratory muscle function and strength in patients who survived a hospitalisation for a severe COVID-19-infection (25 with a severe course requiring mechanical ventilation in the intensive care unit, 25 with a moderate-severe course requiring administration of supplemental oxygen only, respectively)
Jens Spiesshoefer
Aachen, North Rhine-Westphalia, Germany
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.
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.
Blood samples obtained based on venous puncture
Michael Dreher, Professor
RWTH Aachen University
Jens Spiesshoefer, MD
RWTH Aachen University
Janina Friedrich, MD
RWTH Aachen University
50 participants (actual enrollment reported by the registry).
First Submitted
April 15, 2021
First Posted
April 22, 2021
Study Start
June 1, 2021
Actual (reported)A Clinical Trial of Convalescent Plasma Compared to Best Supportive Care for Treatment of Patients With Severe COVID-19
Contact the study team to confirm eligibility.
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.
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.2019.04.011. Epub 2019 Apr 25.
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: 10.1159/000500726. Epub 2019 Jul 26.
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. Respiration. 2020;99(5):369-381. doi: 10.1159/000506016. Epub 2020 May 12.
Friedrich J, Regmi B, Jorn B, Senol M, Giannoni A, Boentert M, Kahles F, Daher A, Dreher M, Spiesshoefer J. Poor Correlation between Diaphragm Ultrasound and Invasive Gold Standard Technique Derived Respiratory Muscle Strength Assessment in Patients after Hospitalisation for COVID-19. Respiration. 2025;104(4):231-239. doi: 10.1159/000541632. Epub 2024 Nov 4.
Spiesshoefer J, Regmi B, Senol M, Jorn B, Gorol O, Elfeturi M, Walterspacher S, Giannoni A, Kahles F, Gloeckl R, Dreher M. Potential Diaphragm Muscle Weakness-related Dyspnea Persists 2 Years after COVID-19 and Could Be Improved by Inspiratory Muscle Training: Results of an Observational and an Interventional Clinical Trial. Am J Respir Crit Care Med. 2024 Sep 1;210(5):618-628. doi: 10.1164/rccm.202309-1572OC.
Regmi B, Friedrich J, Jorn B, Senol M, Giannoni A, Boentert M, Daher A, Dreher M, Spiesshoefer J. Diaphragm Muscle Weakness Might Explain Exertional Dyspnea 15 Months after Hospitalization for COVID-19. Am J Respir Crit Care Med. 2023 Apr 15;207(8):1012-1021. doi: 10.1164/rccm.202206-1243OC.
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.
Primary Completion
July 1, 2023
Actual (reported)Study Completion
November 20, 2024
Actual (reported)Last Updated
January 28, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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