Respiratory Muscles After Hospitalisation for COVID-19

NCT04854863 | Completed

• 1 other identifier: CTCA 20-515
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19; Diaphragm Injury

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• 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

Interventions

Comprehensive assessment of respiratory muscle function. DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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)

You may qualify if:

• patients with survived 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)
• Patients aged at least 18 years, who are mentally and physically able to consent and participate into the study

You may not qualify if:

• 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
• Bound to a wheel chair
• Patients who are mentally and physically unable to consent and participate into the study
• Patients in an interdependence or with an employment contract with the principal investigator, Co-PI or his deputy.
• Emergency hospital stay in the last 4 weeks preceding the day of the measurements

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Jens Spiesshoefer

Aachen, North Rhine-Westphalia, Germany

Location

Related Publications (10)

• 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.

  PMID: 33500431 BACKGROUND

• 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.

  PMID: 33120193 BACKGROUND

• 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.

  PMID: 33513168 BACKGROUND

• 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.

  PMID: 31029769 BACKGROUND

• 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.

  PMID: 31352459 BACKGROUND

• 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.

  PMID: 32396905 BACKGROUND

• 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.

  PMID: 39496245 DERIVED

• 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.

  PMID: 38763165 DERIVED

• 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.

  PMID: 36596223 DERIVED

• 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.

  PMID: 35841032 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples obtained based on venous puncture

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Dreher, Professor

  RWTH Aachen University

  STUDY DIRECTOR

• Jens Spiesshoefer, MD

  RWTH Aachen University

  PRINCIPAL INVESTIGATOR

• Janina Friedrich, MD

  RWTH Aachen University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jens Spiesshoefer, MD, PhD Candidate, Group Head Respiratory Physiology

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 22, 2021
• Study Start: June 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: November 20, 2024
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

DE (1)