Respiratory Muscles After Inspiratory Muscle Training After COVID-19

NCT05582642 | Completed

• 1 other identifier: CTCA 250-22 / 22-241
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Diaphragm Injury

Outcome Measures

Primary Outcomes (6)

• Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)

  Assessed at baseline

• Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)

  Assessed after 6 weeks of IMT

• Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)

  Assessed 6 weeks after IMT

• Respiratory mouth pressures

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

  Assessed at baseline

• Respiratory mouth pressures

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

  Assessed after 6 weeks of IMT

• Respiratory mouth pressures

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

  Assessed 6 weeks after IMT

Secondary Outcomes (12)

• Diaphragm and Intercostal ultrasound

  Assessed at baseline

• Diaphragm and Intercostal ultrasound

  Assessed after 6 weeks of IMT

• Diaphragm and Intercostal ultrasound

  Assessed 6 weeks after IMT

• Exercise intolerance

  Assessed at baseline

• Exercise intolerance

  Assessed after 6 weeks of IMT

Study Arms (2)

Diaphragm Strength Training

ACTIVE COMPARATOR

Device: Inspiratory Muscle Training (IMT)

Diaphragm Endurance Training

SHAM COMPARATOR

Device: Inspiratory Muscle Training (IMT)

Interventions

Inspiratory Muscle Training (IMT) DEVICE

The training itself includes 2 x 30 breathing cycles per day. The whole training should take place daily, 7 days a week. The initial training intensity in the treatment arm (resistance of the respiratory muscle training) is set to 50% of the maximum respiratory muscle strength (measured using PImax). Once a week the present investigators get a picture of patient's training, pay attention to shortness of breath, potential for adaptation. In the "control" arm of the study, this force adjustment would not take place, i.e. it is an endurance training of the diaphragm (10% of PI Max over the whole 6 weeks) with, however, also the control dates of the training twice a week. At least in the 6 weeks of the study (see above).

Diaphragm Endurance Training; Diaphragm Strength Training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• RWTH Aachen University: lead
• Philipps University Marburg: collaborator

Study Sites (1)

RWTH Aachen University

Aachen, 52074, Germany

Location

Related Publications (8)

• 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, 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 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 RESULT

• 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 RESULT

• 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 RESULT

• 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

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

• Jens Spiesshoefer, MD

  RWTH Aachen University

  PRINCIPAL INVESTIGATOR

• Binaya Regmi, MD

  RWTH Aachen University

  STUDY CHAIR

• Michael Dreher, Professor

  RWTH Aachen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2022
• First Posted: October 17, 2022
• Study Start: October 17, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)