COVID-19NCT05582642
Respiratory Muscles After Inspiratory Muscle Training After COVID-19
A study testing Inspiratory Muscle Training (IMT) in people with COVID-19 and Diaphragm Injury, run by RWTH Aachen University at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19, Diaphragm Injury
- What is being tested?
- Inspiratory Muscle Training (IMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- 17 Oct 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Muscles After Inspiratory Muscle Training in Patients After COVID-19 With Persistent Dyspnea and Respiratory Muscle Dysfunction
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.
Read the detailed description
Breathing is a complex process involving muscular, neurological and chemical processes in the body. Herein, the respiratory muscles play a very important role.
The respiratory muscles are the muscle groups that cause the expansion and contraction of the chest during inhalation and exhalation. The most important respiratory muscle is the diaphragm. It is known that long-term ventilation in the intensive care unit weakens the respiratory muscles, since the work of the muscles is taken over by the ventilation devices and the muscles are not trained over a long period of time.
As recently shown, COVID-19 disease can lead to diaphragmatic weakness even in the absence of ventilation.
In this project (CTCA 20-515) the present investigators demonstrated that several patients after COVID-19 suffer from diaphragmatic weakness. Specifically, diaphragmatic weakness also related to shortness of breath complained about by patients and currently not otherwise explainable.
The so-called inspiratory muscle training (IMT or diaphragm training) is known in pneumological rehabilitation for years. In the current project, after the training has been explained, the patient is asked to breathe against resistance at home using a small mouthpiece and a small device several times (twice) a day and several times a week (each day).
This procedure is considered safe and very effective in training the diaphragm. Accordingly, it is the aim of the current (follow-up) project for the first time in post-COVID patients who continue to complain of shortness of breath and for whom there is no other explanation than possibly the proven diaphragmatic weakness, to determine the effects of 6 weeks of IMT/diaphragm training on diaphragm strength and on shortness of breath.
At the beginning and at the end of the 6 weeks of training, the present investigators would carry out the all-encompassing measurement of diaphragm force, which is known to patients and explained again below. Furthermore, the present investigators would invite patients twice a week to optimize the training together (for a maximum of 1 hour per appointment). This would take place once a week in the present investigators laboratory for respiratory physiology and the training would be improved it if necessary, once a week.
The training would end after 6 weeks and the present investigators would measure diaphragm function again 6 weeks after the training, i.e. a third time in total, to determine whether the effects seen continue to be present after the training. After that, the study ends.
The present investigators would offer the treatment arm (the 9/18 patients) in whom diaphragm endurance training was carried out as a control of the diaphragmatic strength training to carry out strength training after the measurement 6 weeks after the end of the therapy (outside of this study here as a purely clinical therapy).
The training itself includes 2 x 30 breathing cycles per day. Patients can divide these 2 x 30 breathing cycles freely, i.e. specifically train 1 x 30 breathing cycles in the morning and 1 x 30 breathing cycles in the afternoon. The whole training should take place daily, 7 days a week.
Once a week the present investigators get a picture of the patient's training, pay attention to shortness of breath, potential for adaptation (also specifically for even stronger training, if tolerated by the patients, increase in training, i.e. the breathing resistance that patients would have to overcome when inhaling ).
In the "control" arm of the study, this force adjustment would not take place, i.e. it is an endurance training of the diaphragm with, however, also the control dates of the training twice a week. At least in the 6 weeks of the study (see above).
- Conditions
- COVID-19, Diaphragm Injury
- Being tested
- Inspiratory Muscle Training (IMT)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Diaphragm Strength Training | Active comparator | Not described Receives: Device: Inspiratory Muscle Training (IMT) |
| Diaphragm Endurance Training | Sham comparator | Not described Receives: Device: Inspiratory Muscle Training (IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)
Measured: Assessed at baseline
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)
Measured: Assessed after 6 weeks of IMT
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)
Measured: Assessed 6 weeks after IMT
Respiratory mouth pressures
Measurement of respiratory (inspiratory and expiratory) mouth pressures (Unit: Pressure in cmH2O)
Measured: Assessed at baseline
Respiratory mouth pressures
Measurement of respiratory (inspiratory and expiratory) mouth pressures (Unit: Pressure in cmH2O)
Measured: Assessed after 6 weeks of IMT
Respiratory mouth pressures
Measurement of respiratory (inspiratory and expiratory) mouth pressures (Unit: Pressure in cmH2O)
Measured: Assessed 6 weeks after IMT
Secondary outcomes (12)
Diaphragm and Intercostal ultrasound
Thickening fraction (Unit: %)
Measured: Assessed at baseline
Diaphragm and Intercostal ultrasound
Thickening fraction (Unit: %)
Measured: Assessed after 6 weeks of IMT
Diaphragm and Intercostal ultrasound
Thickening fraction (Unit: %)
Measured: Assessed 6 weeks after IMT
Exercise intolerance
Dyspnea (Borg dyspnea scale; Unit 1-10 with higher values indicating more severe dyspnea)
Measured: Assessed at baseline
Exercise intolerance
Dyspnea (Borg dyspnea scale; Unit 1-10 with higher values indicating more severe dyspnea)
Measured: Assessed after 6 weeks of IMT
Exercise intolerance
Dyspnea (Borg dyspnea scale; Unit 1-10 with higher values indicating more severe dyspnea)
Measured: Assessed 6 weeks after IMT
Lung function
Comprehensive assessment of lung function (most importantly forced vital capacity; Unit Liters)
Measured: Assessed at baseline
Lung function
Comprehensive assessment of lung function (most importantly forced vital capacity; Unit Liters)
Measured: Assessed after 6 weeks of IMT
Lung function
Comprehensive assessment of lung function (most importantly forced vital capacity; Unit Liters)
Measured: Assessed 6 weeks after IMT
Electromyography of diaphragm and accessory respiratory muscle activity
Activity of the respiratory muscles (Unit: % with higher values indicating higher activity of the respiratory muscles)
Measured: Assessed at baseline
Electromyography of diaphragm and accessory respiratory muscle activity
Activity of the respiratory muscles (Unit: % with higher values indicating higher activity of the respiratory muscles)
Measured: Assessed after 6 weeks of IMT
Electromyography of diaphragm and accessory respiratory muscle activity
Activity of the respiratory muscles (Unit: % with higher values indicating higher activity of the respiratory muscles)
Measured: Assessed 6 weeks after IMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start17 Oct 2022
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Philipps University Marburg
- Responsible party
- Principal investigator, Jens Spießhöfer, RWTH Aachen University
- Investigators
- Jens Spiesshoefer, MD, Principal investigator, RWTH Aachen UniversityBinaya Regmi, MD, Study chair, RWTH Aachen UniversityMichael Dreher, Professor, Study director, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582642
- Sponsor's protocol ID
- CTCA 250-22 / 22-241
- Status last verified
- Jan 2026
- First submitted
- 9 Oct 2022
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33500431Daher 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.
PubMed 33120193Balfanz 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.
PubMed 33513168Spiesshoefer 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.
PubMed 35841032Spiesshoefer 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.
PubMed 31029769Spiesshoefer 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.
PubMed 31352459Spiesshoefer 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.
PubMed 32396905Spiesshoefer 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.
PubMed 38763165
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscles After Inspiratory Muscle Training in Patients After COVID-19 With Persistent Dyspnea and Respiratory Muscle Dysfunction
- ClinicalTrials.gov ID
- NCT05582642
- Acronym / sponsor ID
- CTCA 250-22 / 22-241
- Conditions
- COVID-19, Diaphragm Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Philipps University Marburg
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breathing is a complex process involving muscular, neurological and chemical processes in the body. Herein, the respiratory muscles play a very important role.
The respiratory muscles are the muscle groups that cause the expansion and contraction of the chest during inhalation and exhalation. The most important respiratory muscle is the diaphragm. It is known that long-term ventilation in the intensive care unit weakens the respiratory muscles, since the work of the muscles is taken over by the ventilation devices and the muscles are not trained over a long period of time.
As recently shown, COVID-19 disease can lead to diaphragmatic weakness even in the absence of ventilation.
In this project (CTCA 20-515) the present investigators demonstrated that several patients after COVID-19 suffer from diaphragmatic weakness. Specifically, diaphragmatic weakness also related to shortness of breath complained about by patients and currently not otherwise explainable.
The so-called inspiratory muscle training (IMT or diaphragm training) is known in pneumological rehabilitation for years. In the current project, after the training has been explained, the patient is asked to breathe against resistance at home using a small mouthpiece and a small device several times (twice) a day and several times a week (each day).
This procedure is considered safe and very effective in training the diaphragm. Accordingly, it is the aim of the current (follow-up) project for the first time in post-COVID patients who continue to complain of shortness of breath and for whom there is no other explanation than possibly the proven diaphragmatic weakness, to determine the effects of 6 weeks of IMT/diaphragm training on diaphragm strength and on shortness of breath.
At the beginning and at the end of the 6 weeks of training, the present investigators would carry out the all-encompassing measurement of diaphragm force, which is known to patients and explained again below. Furthermore, the present investigators would invite patients twice a week to optimize the training together (for a maximum of 1 hour per appointment). This would take place once a week in the present investigators laboratory for respiratory physiology and the training would be improved it if necessary, once a week.
The training would end after 6 weeks and the present investigators would measure diaphragm function again 6 weeks after the training, i.e. a third time in total, to determine whether the effects seen continue to be present after the training. After that, the study ends.
The present investigators would offer the treatment arm (the 9/18 patients) in whom diaphragm endurance training was carried out as a control of the diaphragmatic strength training to carry out strength training after the measurement 6 weeks after the end of the therapy (outside of this study here as a purely clinical therapy).
The training itself includes 2 x 30 breathing cycles per day. Patients can divide these 2 x 30 breathing cycles freely, i.e. specifically train 1 x 30 breathing cycles in the morning and 1 x 30 breathing cycles in the afternoon. The whole training should take place daily, 7 days a week.
Once a week the present investigators get a picture of the patient's training, pay attention to shortness of breath, potential for adaptation (also specifically for even stronger training, if tolerated by the patients, increase in training, i.e. the breathing resistance that patients would have to overcome when inhaling ).
In the "control" arm of the study, this force adjustment would not take place, i.e. it is an endurance training of the diaphragm with, however, also the control dates of the training twice a week. At least in the 6 weeks of the study (see above).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragm Strength Training | Active comparator | Device: Inspiratory Muscle Training (IMT) |
| Diaphragm Endurance Training | Sham comparator | Device: Inspiratory Muscle Training (IMT) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle Training (IMT)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). | Device | Diaphragm Endurance Training, Diaphragm Strength Training |
Primary outcome
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)
Time frame: Assessed at baseline
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)
Time frame: Assessed after 6 weeks of IMT
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O)
Time frame: Assessed 6 weeks after IMT
Respiratory mouth pressures
Time frame: Assessed at baseline
Measurement of respiratory (inspiratory and expiratory) mouth pressures (Unit: Pressure in cmH2O)
Respiratory mouth pressures
Time frame: Assessed after 6 weeks of IMT
Measurement of respiratory (inspiratory and expiratory) mouth pressures (Unit: Pressure in cmH2O)
Respiratory mouth pressures
Time frame: Assessed 6 weeks after IMT
Measurement of respiratory (inspiratory and expiratory) mouth pressures (Unit: Pressure in cmH2O)
12 secondary outcomes
Diaphragm and Intercostal ultrasound
Time frame: Assessed at baseline
Diaphragm and Intercostal ultrasound
Time frame: Assessed after 6 weeks of IMT
Diaphragm and Intercostal ultrasound
Time frame: Assessed 6 weeks after IMT
Exercise intolerance
Time frame: Assessed at baseline
Exercise intolerance
Time frame: Assessed after 6 weeks of IMT
Exercise intolerance
Time frame: Assessed 6 weeks after IMT
Lung function
Time frame: Assessed at baseline
Lung function
Time frame: Assessed after 6 weeks of IMT
Lung function
Time frame: Assessed 6 weeks after IMT
Electromyography of diaphragm and accessory respiratory muscle activity
Time frame: Assessed at baseline
Electromyography of diaphragm and accessory respiratory muscle activity
Time frame: Assessed after 6 weeks of IMT
Electromyography of diaphragm and accessory respiratory muscle activity
Time frame: Assessed 6 weeks after IMT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 33500431Daher 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.
- Background: PubMed 33120193Daher 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.
- Background: PubMed 33513168Balfanz 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.
- Background: PubMed 35841032Spiesshoefer 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.
- Results publication: PubMed 31029769Spiesshoefer 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.
- Results publication: PubMed 31352459Spiesshoefer 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.
- Results publication: PubMed 32396905Spiesshoefer 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.
- Derived from this study: PubMed 38763165Spiesshoefer 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.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Spiesshoefer, MD principal investigator
RWTH Aachen University
Binaya Regmi, MD study chair
RWTH Aachen University
Michael Dreher, Professor study director
RWTH Aachen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training (IMT) in people with COVID-19 and Diaphragm Injury, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Twitch transdiaphragmatic pressure in response to supramaximal magnetic stimulation of the phrenic nerve roots (Unit: Pressure in cmH2O) (time frame: Assessed at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05582642, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.