Weaning FailureTrainToWeanNCT04658498
Improving Our Understanding of Respiratory Muscle Training to Facilitate Weaning From Mechanical Ventilation in the ICU
A study testing Procedure: UC + HI-IMT in people with Weaning Failure, run by KU Leuven at 1 site in Belgium.
Trial summary
Mechanical ventilation is a life-saving treatment frequently applied in intensive care unit (ICU). Nonetheless, by putting at rest the respiratory muscles, it can lead to respiratory muscle weakness and atrophy, which are accompanied by prolonged duration of mechanical ventilation, difficult weaning and increased ICU… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure
- What is being tested?
- Procedure: UC + HI-IMT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Difficult and prolonged weaning patients
- Adequate oxygenation
- Febrile temperature < 38ºC
- Hemodynamic stability
- Stable blood pressure
- No or minimal vasopressors
Show all 11Show fewer
- No myocardial ischemia
- Adequate hemoglobin and mentation
- Resolution of disease acute phase
- Able to follow simple verbal commands related to IMT
- Mechanically ventilated via a tracheostomy or endotracheal tube
Who cannot join
- Pre-existing neuromuscular disease
- Agitation
- Hemodynamically instable (arrhythmia, decompensated heart failure, coronary insufficiency)
- Hemoptysis
- Diaphoresis
- Spinal cord injury above T8
Show all 9Show fewer
- Use of any type of home MV support prior to hospitalization
- Skeletal pathology that impairs chest wall movements
- Poor general prognosis or fatal outcome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Leuven
Leuven, 3000
Daniel Langer, daniel.langer@kuleuven.be
Daniel Langer, PT, PhD
About this study
Mechanical ventilation is a life-saving treatment frequently applied in intensive care unit (ICU). Nonetheless, by putting at rest the respiratory muscles, it can lead to respiratory muscle weakness and atrophy, which are accompanied by prolonged duration of mechanical ventilation, difficult weaning and increased ICU mortality. Despite a strong theoretical rationale and some evidence supporting the use of inspiratory muscle training (IMT) to address respiratory muscle weakness and atrophy, the optimal approach to IMT remains largely uncertain. In fact, mechanistic studies evaluating physiological adaptations that occur in respiratory muscles of mechanically ventilated patients in response to different training regimens have not been conducted so far.
The aim of this study is to comprehensively investigate changes in respiratory muscle function in response to three different conditions that patients will be exposed to during their period of weaning from mechanical ventilation.
Read the detailed description
A majority of mechanically ventilated patients develop respiratory muscle weakness during critical illness.
The potential value of implementing rehabilitative interventions for respiratory muscle conditioning are supported by observations showing that respiratory muscle weakness is associated with prolonged duration of mechanical ventilation, difficult weaning, and increased ICU mortality.
Despite a strong theoretical rationale and some evidence supporting its use, mechanistic studies evaluating physiological adaptations that occur in respiratory muscles of mechanically ventilated patients in response to different training regimens have not been performed so far. Consequently, the characterization of IMT modalities and of the optimal approach to IMT remain largely uncertain.
To date, the great part of the studies on the topic employed an external mechanical threshold device to perform trainings, in general adopting loads ranging between 10-50% of maximal inspiratory strength (i.e. maximal inspiratory pressure (PImax)). Intermittent spontaneous breathing periods (e.g. using partially assisted or spontaneous modes of ventilation) are also frequently applied as an activating stimulus to the respiratory muscles during periods of mechanical ventilation.
A tapered flow resistive load (TFRL) device (POWERbreathe KH2, HaB International, UK) has been already tested and implemented at University Hospital Leuven as a way of loading respiratory muscles in ICU patients. The TFRL approach represents a potential more optimal way of loading the respiratory muscles in patients on prolonged mechanical ventilation. Such a loading approach allows higher inspiratory tidal volumes to be reached and higher work and power generation during trainings, by adapting to changes in length-tension characteristics of the inspiratory muscles during inspiration.
With regards to training modalities, high-intensity IMT modalities by applying loads ranging between 30 and 50 %PImax, have not yet been proven to be associated with better improvements in respiratory muscle strength compared to low-intensity (sham) IMT modalities at loads not exceeding 10 %PImax.
On the other hand, no studies are available that assessed changes in respiratory muscle function beyond assessments of respiratory muscle strength in response to training.
Additionally, no training studies have tried to quantify the intrinsic loading of the patients (i.e. elastic and resistive resistances of the chest wall and the lungs) that muscles are exposed to in between periods of additional loading applied during IMT sessions.
The aim of this study is to comprehensively investigate changes in respiratory muscle function in response to three different conditions that difficult to wean patients will be exposed to during their weaning period. The complementary quantification of the entity of loading that respiratory muscles are bearing during assisted, spontaneous and resistive breathing would provide important novel insights on the optimization of IMT stimulus in different patients on prolonged mechanical ventilation.
- Conditions
- Weaning Failure
- Being tested
- Procedure: Usual Care (UC), Procedure: UC + HI-IMT, Procedure: UC + LI-IMT (sham IMT)
- Keywords
- ICU acquired muscle weakness, IMT, Weaning outcomes, Maximal inspiratory pressure, Diaphragm EMG, Surface EMG, Diaphragm ultrasounds, Microbiopsies, Difficult to wean patients, Respiratory muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: Usual Care (UC)Other
Intermittent spontaneous breathing periods
Procedure: UC + HI-IMTOther
UC + Supervised daily sessions of training including 4 sets of 6-10 full vital capacity breaths against an external load using a tapered flow resistive device (POWERbreathe KH2, HaB International, UK). The maximum tolerable resistance allowing patients to inhale at least 70% of their inspiratory vital capacity will be chosen and progressively increased throughout the training period.
Procedure: UC + LI-IMT (sham IMT)Other
UC + superrvised daily sessions of training including 4 sets of 6-10 breaths at the lowest external imposable load with the tapered flow resistive device (POWERbreathe KH2, HaB International, UK) (i.e. 3 cmH2O).
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (UC) | Experimental | Intermittent spontaneous breathing periods Receives: Other: Procedure: Usual Care (UC) |
| UC + High-intensity inspiratory muscle training (HI-IMT) | Experimental | Not described Receives: Other: Procedure: UC + HI-IMT |
| UC + Low-intensity inspiratory muscle training (LI-IMT) (sham IMT) | Experimental | Not described Receives: Other: Procedure: UC + LI-IMT (sham IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure (PImax)
Using a unidirectional valve which will be connected to the patient's tracheostomy tube or endotracheal tube for an uninterrupted period of 25 seconds.
Measured: Maximal duration of IMT treatment: 28 days
Secondary outcomes (14)
Diaphragm mobility, thickness and thickening fraction by ultrasounds
Assessment by diaphragm ultrasounds
Measured: Maximal duration of IMT treatment: 28 days
Change in contractile material and structural alteration of sternocleidomastoid muscle
By analyzing muscle microbiopsies using Hematoxylin \& Eosin (H\&E) staining.
Measured: Maximal duration of IMT treatment: 28 days
Change in fiber proportion of sternocleidomastoid muscle fibers
By analyzing muscle microbiopsies with immunostaining of the myosin heavy chain.
Measured: Maximal duration of IMT treatment: 28 days
Change in size of sternocleidomastoid muscle fibers
By analyzing muscle microbiopsies with immunostaining of the myosin heavy chain.
Measured: Maximal duration of IMT treatment: 28 days
Change in amount of satellite cells of sternocleidomastoid muscle
By analyzing muscle microbiopsies with Pax7 immunostaining
Measured: Maximal duration of IMT treatment: 28 days
Change in amount of fibrotic tissue of sternocleidomastoid muscle
By analyzing muscle microbiopsies with Masson staining
Measured: Maximal duration of IMT treatment: 28 days
Change of gene expression of atrophy/hypertrophy related pathways of sternocleidomastoid muscle
By analyzing muscle microbiopsies with RT2 profiler PCR array skeletal muscle, Qiagen
Measured: Maximal duration of IMT treatment: 28 days
Change in cell proliferation of sternocleidomastoid muscle
By analyzing muscle microbiopsies cell proliferation assays
Measured: Maximal duration of IMT treatment: 28 days
Change in cell differentiation of sternocleidomastoid muscle
By analyzing muscle microbiopsies cell differentiation assays
Measured: Maximal duration of IMT treatment: 28 days
Change in Blood Flow Index (BFI) of extra-diaphragmatic respiratory muscles
Measured by near-infrared spectroscopy in combination with injections of the tracer indocyanine green dye (ICG), with optodes transcutaneously positioned on the scalene, sternocleidomastoid and upper rectus abdominis muscles.
Measured: Maximal duration of IMT treatment: 28 days
Change in Tissue Oxygenation Index (TOI) of ex of extra-diaphragmatic respiratory muscles
Measured by near-infrared spectroscopy with optodes transcutaneously positioned on the scalene, sternocleidomastoid and upper rectus abdominis muscles
Measured: Maximal duration of IMT treatment: 28 days
Change in signal amplitude of diaphragm electromyography
Diaphragm electromyography will be collected with an esophageal electrode catheter
Measured: Maximal duration of IMT treatment: 28 days
Change in signal amplitude of electromyography of extra-diaphragmatic respiratory muscles
Electromyography of scalene, sternocleidomastoid, parasternal intercostal and rectus abdominis muscles will be collected through surface electromyography electrodes
Measured: Maximal duration of IMT treatment: 28 days
Esophageal and gastric pressure
Using a multifunction nasogastric catheter
Measured: Maximal duration of IMT treatment: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Feb 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Model description
- Double-blind, three arms parallel group randomized controlled trial with 1:1:1 allocation ratio
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Langer, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658498
- Sponsor's protocol ID
- S64871
- Acronym
- TrainToWean
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2020
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dres M, Goligher EC, Heunks LMA, Brochard LJ. Critical illness-associated diaphragm weakness. Intensive Care Med. 2017 Oct;43(10):1441-1452. doi: 10.1007/s00134-017-4928-4. Epub 2017 Sep 15.
PubMed 28917004Vorona S, Sabatini U, Al-Maqbali S, Bertoni M, Dres M, Bissett B, Van Haren F, Martin AD, Urrea C, Brace D, Parotto M, Herridge MS, Adhikari NKJ, Fan E, Melo LT, Reid WD, Brochard LJ, Ferguson ND, Goligher EC. Inspiratory Muscle Rehabilitation in Critically Ill Adults. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2018 Jun;15(6):735-744. doi: 10.1513/AnnalsATS.201712-961OC.
PubMed 29584447Supinski GS, Callahan LA. Diaphragm weakness in mechanically ventilated critically ill patients. Crit Care. 2013 Jun 20;17(3):R120. doi: 10.1186/cc12792.
PubMed 23786764Dres M, Goligher EC, Dube BP, Morawiec E, Dangers L, Reuter D, Mayaux J, Similowski T, Demoule A. Diaphragm function and weaning from mechanical ventilation: an ultrasound and phrenic nerve stimulation clinical study. Ann Intensive Care. 2018 Apr 23;8(1):53. doi: 10.1186/s13613-018-0401-y.
PubMed 29687276Elkins M, Dentice R. Inspiratory muscle training facilitates weaning from mechanical ventilation among patients in the intensive care unit: a systematic review. J Physiother. 2015 Jul;61(3):125-34. doi: 10.1016/j.jphys.2015.05.016. Epub 2015 Jun 16.
PubMed 26092389Langer D, Charususin N, Jacome C, Hoffman M, McConnell A, Decramer M, Gosselink R. Efficacy of a Novel Method for Inspiratory Muscle Training in People With Chronic Obstructive Pulmonary Disease. Phys Ther. 2015 Sep;95(9):1264-73. doi: 10.2522/ptj.20140245. Epub 2015 Apr 9.
PubMed 25858974Hoffman M, Van Hollebeke M, Clerckx B, Muller J, Louvaris Z, Gosselink R, Hermans G, Langer D. Can inspiratory muscle training improve weaning outcomes in difficult to wean patients? A protocol for a randomised controlled trial (IMweanT study). BMJ Open. 2018 Jun 30;8(6):e021091. doi: 10.1136/bmjopen-2017-021091.
PubMed 29961023Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.
PubMed 30956204Poddighe D, Van Hollebeke M, Clerckx B, Janssens L, Molenberghs G, Van Dyck L, Muller J, Gunst J, Meersseman P, Peetermans M, Hermans G, Gosselink R, Langer D. Inspiratory effort and respiratory muscle activation during different breathing conditions in patients with weaning difficulties: An exploratory study. Aust Crit Care. 2025 May;38(3):101152. doi: 10.1016/j.aucc.2024.101152. Epub 2025 Jan 21.
PubMed 39842329
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Our Understanding of Respiratory Muscle Training to Facilitate Weaning From Mechanical Ventilation in the ICU
- ClinicalTrials.gov ID
- NCT04658498
- Acronym / sponsor ID
- TrainToWean / S64871
- Conditions
- Weaning Failure
- Keywords
- ICU acquired muscle weakness, IMT, Weaning outcomes, Maximal inspiratory pressure, Diaphragm EMG, Surface EMG, Diaphragm ultrasounds, Microbiopsies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 Dec 2020 (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.
Mechanical ventilation is a life-saving treatment frequently applied in intensive care unit (ICU). Nonetheless, by putting at rest the respiratory muscles, it can lead to respiratory muscle weakness and atrophy, which are accompanied by prolonged duration of mechanical ventilation, difficult weaning and increased ICU mortality. Despite a strong theoretical rationale and some evidence supporting the use of inspiratory muscle training (IMT) to address respiratory muscle weakness and atrophy, the optimal approach to IMT remains largely uncertain. In fact, mechanistic studies evaluating physiological adaptations that occur in respiratory muscles of mechanically ventilated patients in response to different training regimens have not been conducted so far.
The aim of this study is to comprehensively investigate changes in respiratory muscle function in response to three different conditions that patients will be exposed to during their period of weaning from mechanical ventilation.
Detailed description
A majority of mechanically ventilated patients develop respiratory muscle weakness during critical illness.
The potential value of implementing rehabilitative interventions for respiratory muscle conditioning are supported by observations showing that respiratory muscle weakness is associated with prolonged duration of mechanical ventilation, difficult weaning, and increased ICU mortality.
Despite a strong theoretical rationale and some evidence supporting its use, mechanistic studies evaluating physiological adaptations that occur in respiratory muscles of mechanically ventilated patients in response to different training regimens have not been performed so far. Consequently, the characterization of IMT modalities and of the optimal approach to IMT remain largely uncertain.
To date, the great part of the studies on the topic employed an external mechanical threshold device to perform trainings, in general adopting loads ranging between 10-50% of maximal inspiratory strength (i.e. maximal inspiratory pressure (PImax)). Intermittent spontaneous breathing periods (e.g. using partially assisted or spontaneous modes of ventilation) are also frequently applied as an activating stimulus to the respiratory muscles during periods of mechanical ventilation.
A tapered flow resistive load (TFRL) device (POWERbreathe KH2, HaB International, UK) has been already tested and implemented at University Hospital Leuven as a way of loading respiratory muscles in ICU patients. The TFRL approach represents a potential more optimal way of loading the respiratory muscles in patients on prolonged mechanical ventilation. Such a loading approach allows higher inspiratory tidal volumes to be reached and higher work and power generation during trainings, by adapting to changes in length-tension characteristics of the inspiratory muscles during inspiration.
With regards to training modalities, high-intensity IMT modalities by applying loads ranging between 30 and 50 %PImax, have not yet been proven to be associated with better improvements in respiratory muscle strength compared to low-intensity (sham) IMT modalities at loads not exceeding 10 %PImax.
On the other hand, no studies are available that assessed changes in respiratory muscle function beyond assessments of respiratory muscle strength in response to training.
Additionally, no training studies have tried to quantify the intrinsic loading of the patients (i.e. elastic and resistive resistances of the chest wall and the lungs) that muscles are exposed to in between periods of additional loading applied during IMT sessions.
The aim of this study is to comprehensively investigate changes in respiratory muscle function in response to three different conditions that difficult to wean patients will be exposed to during their weaning period. The complementary quantification of the entity of loading that respiratory muscles are bearing during assisted, spontaneous and resistive breathing would provide important novel insights on the optimization of IMT stimulus in different patients on prolonged mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, three arms parallel group randomized controlled trial with 1:1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Usual Care (UC) | Experimental | Other: Procedure: Usual Care (UC)Intermittent spontaneous breathing periods |
| UC + High-intensity inspiratory muscle training (HI-IMT) | Experimental | Other: Procedure: UC + HI-IMT |
| UC + Low-intensity inspiratory muscle training (LI-IMT) (sham IMT) | Experimental | Other: Procedure: UC + LI-IMT (sham IMT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Difficult and prolonged weaning patients
- Adequate oxygenation
- Febrile temperature < 38ºC
- Hemodynamic stability
- Stable blood pressure
Key exclusion criteria (9 listed)
- Pre-existing neuromuscular disease
- Agitation
- Hemodynamically instable (arrhythmia, decompensated heart failure, coronary insufficiency)
- Hemoptysis
- Diaphoresis
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 |
|---|---|---|
| Procedure: Usual Care (UC)Intermittent spontaneous breathing periods | Other | Usual Care (UC) |
| Procedure: UC + HI-IMTUC + Supervised daily sessions of training including 4 sets of 6-10 full vital capacity breaths against an external load using a tapered flow resistive device (POWERbreathe KH2, HaB International, UK). The maximum tolerable resistance allowing patients to inhale at least 70% of their inspiratory vital capacity will be chosen and progressively increased throughout the training period. | Other | UC + High-intensity inspiratory muscle training (HI-IMT) |
| Procedure: UC + LI-IMT (sham IMT)UC + superrvised daily sessions of training including 4 sets of 6-10 breaths at the lowest external imposable load with the tapered flow resistive device (POWERbreathe KH2, HaB International, UK) (i.e. 3 cmH2O). | Other | UC + Low-intensity inspiratory muscle training (LI-IMT) (sham IMT) |
Primary outcome
Maximal Inspiratory Pressure (PImax)
Time frame: Maximal duration of IMT treatment: 28 days
Using a unidirectional valve which will be connected to the patient's tracheostomy tube or endotracheal tube for an uninterrupted period of 25 seconds.
14 secondary outcomes
Diaphragm mobility, thickness and thickening fraction by ultrasounds
Time frame: Maximal duration of IMT treatment: 28 days
Change in contractile material and structural alteration of sternocleidomastoid muscle
Time frame: Maximal duration of IMT treatment: 28 days
Change in fiber proportion of sternocleidomastoid muscle fibers
Time frame: Maximal duration of IMT treatment: 28 days
Change in size of sternocleidomastoid muscle fibers
Time frame: Maximal duration of IMT treatment: 28 days
Change in amount of satellite cells of sternocleidomastoid muscle
Time frame: Maximal duration of IMT treatment: 28 days
Change in amount of fibrotic tissue of sternocleidomastoid muscle
Time frame: Maximal duration of IMT treatment: 28 days
Change of gene expression of atrophy/hypertrophy related pathways of sternocleidomastoid muscle
Time frame: Maximal duration of IMT treatment: 28 days
Change in cell proliferation of sternocleidomastoid muscle
Time frame: Maximal duration of IMT treatment: 28 days
Change in cell differentiation of sternocleidomastoid muscle
Time frame: Maximal duration of IMT treatment: 28 days
Change in Blood Flow Index (BFI) of extra-diaphragmatic respiratory muscles
Time frame: Maximal duration of IMT treatment: 28 days
Change in Tissue Oxygenation Index (TOI) of ex of extra-diaphragmatic respiratory muscles
Time frame: Maximal duration of IMT treatment: 28 days
Change in signal amplitude of diaphragm electromyography
Time frame: Maximal duration of IMT treatment: 28 days
Change in signal amplitude of electromyography of extra-diaphragmatic respiratory muscles
Time frame: Maximal duration of IMT treatment: 28 days
Esophageal and gastric pressure
Time frame: Maximal duration of IMT treatment: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 28917004Dres M, Goligher EC, Heunks LMA, Brochard LJ. Critical illness-associated diaphragm weakness. Intensive Care Med. 2017 Oct;43(10):1441-1452. doi: 10.1007/s00134-017-4928-4. Epub 2017 Sep 15.
- Background: PubMed 29584447Vorona S, Sabatini U, Al-Maqbali S, Bertoni M, Dres M, Bissett B, Van Haren F, Martin AD, Urrea C, Brace D, Parotto M, Herridge MS, Adhikari NKJ, Fan E, Melo LT, Reid WD, Brochard LJ, Ferguson ND, Goligher EC. Inspiratory Muscle Rehabilitation in Critically Ill Adults. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2018 Jun;15(6):735-744. doi: 10.1513/AnnalsATS.201712-961OC.
- Background: PubMed 23786764Supinski GS, Callahan LA. Diaphragm weakness in mechanically ventilated critically ill patients. Crit Care. 2013 Jun 20;17(3):R120. doi: 10.1186/cc12792.
- Background: PubMed 29687276Dres M, Goligher EC, Dube BP, Morawiec E, Dangers L, Reuter D, Mayaux J, Similowski T, Demoule A. Diaphragm function and weaning from mechanical ventilation: an ultrasound and phrenic nerve stimulation clinical study. Ann Intensive Care. 2018 Apr 23;8(1):53. doi: 10.1186/s13613-018-0401-y.
- Background: PubMed 26092389Elkins M, Dentice R. Inspiratory muscle training facilitates weaning from mechanical ventilation among patients in the intensive care unit: a systematic review. J Physiother. 2015 Jul;61(3):125-34. doi: 10.1016/j.jphys.2015.05.016. Epub 2015 Jun 16.
- Background: PubMed 25858974Langer D, Charususin N, Jacome C, Hoffman M, McConnell A, Decramer M, Gosselink R. Efficacy of a Novel Method for Inspiratory Muscle Training in People With Chronic Obstructive Pulmonary Disease. Phys Ther. 2015 Sep;95(9):1264-73. doi: 10.2522/ptj.20140245. Epub 2015 Apr 9.
- Background: PubMed 29961023Hoffman M, Van Hollebeke M, Clerckx B, Muller J, Louvaris Z, Gosselink R, Hermans G, Langer D. Can inspiratory muscle training improve weaning outcomes in difficult to wean patients? A protocol for a randomised controlled trial (IMweanT study). BMJ Open. 2018 Jun 30;8(6):e021091. doi: 10.1136/bmjopen-2017-021091.
- Background: PubMed 30956204Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.
- Derived from this study: PubMed 39842329Poddighe D, Van Hollebeke M, Clerckx B, Janssens L, Molenberghs G, Van Dyck L, Muller J, Gunst J, Meersseman P, Peetermans M, Hermans G, Gosselink R, Langer D. Inspiratory effort and respiratory muscle activation during different breathing conditions in patients with weaning difficulties: An exploratory study. Aust Crit Care. 2025 May;38(3):101152. doi: 10.1016/j.aucc.2024.101152. Epub 2025 Jan 21.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: UC + HI-IMT in people with Weaning Failure, run by KU Leuven at 1 site in Belgium.
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 11 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 18 Mar 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 Belgium. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Langer, PT, PhD (+3216330192, daniel.langer@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspiratory Pressure (PImax) (time frame: Maximal duration of IMT treatment: 28 days). 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 NCT04658498, which also lists 9 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 18 Mar 2026.