Respiratory Muscle Assesment in COVID-patients Without Hospitalization

NCT06105450 | Completed

• 1 other identifier: 23-296
• Study Type: observational
• Target: 25
• 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. 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.

Conditions

Covid19; Diaphragm Injury

Keywords

Respiratory muscle functtion

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)

  1 year

• Respiratory mouth pressures

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

  1 year

Secondary Outcomes (4)

• Diaphragm ultrasound

  1 year

• Exercise intolerance

  1 year

• Lung function

  1 year

• EMG

  1 year

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

Study Population

A total of 25 patients will be enrolled. Patients from the outpatient clinic of Department of Pneumology and Intensive Care UKA Aachen with a COVID infection at least six months ago without the need for hospitalization during the initial infection phase. Those patients will be compared with healthy controls (availaible data from pre-covid era) matched in a 3:1 ratio for age, sex and body mass index (BMI).

You may qualify if:

• 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

You may not qualify if:

• 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
• Epilepsy
• Bound to a wheel chair

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Jens Spiesshoefer

Aachen, North Rhine-Westphalia, Germany

Location

Related Publications (5)

• 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 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

• Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10.

  PMID: 33692530 BACKGROUND

• Langer D, Ciavaglia C, Faisal A, Webb KA, Neder JA, Gosselink R, Dacha S, Topalovic M, Ivanova A, O'Donnell DE. Inspiratory muscle training reduces diaphragm activation and dyspnea during exercise in COPD. J Appl Physiol (1985). 2018 Aug 1;125(2):381-392. doi: 10.1152/japplphysiol.01078.2017. Epub 2018 Mar 15.

  PMID: 29543134 BACKGROUND

• Griffin L, Cafarelli E. Resistance training: cortical, spinal, and motor unit adaptations. Can J Appl Physiol. 2005 Jun;30(3):328-40. doi: 10.1139/h05-125.

  PMID: 16129897 BACKGROUND

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

• Binaya Regmi, 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: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: October 27, 2023
• Study Start: December 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)