Critical Illness MyopathyNCT07055789
Is Combined Respiratory Muscle Training, Incorporating Inspiratory and Expiratory Training, Feasible in Adult Critical-care Patients?
A study testing Combined respiratory muscle training, incorporating both inspiratory and expiratory muscle training in people with Critical Illness Myopathy and Critical Illness, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial summary
Background: Respiratory muscle weakness is a recognised consequence of mechanical ventilation in critical care. This weakness can have implications for patients, leading to prolonged mechanical ventilation (MV) and intensive care unit (ICU) length of stay (LOS), with worse mortality and morbidity outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness Myopathy, Critical Illness
- What is being tested?
- Combined respiratory muscle training, incorporating both inspiratory and expiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIreland
- Study dates
- 1 Oct 2024to 12 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18years,
- mechanically ventilated for ≥ 24 hours,
- able to initiate spontaneous breaths on MV,
- on suitable levels of respiratory support with ≤.6 FiO2, ≤10 PEEP,
- deemed eligible for MV weaning by ICU consultant or recently extubated (<48 hours),
- alert and collaborative (RASS -2 to +2).
Who cannot join
- patients deemed medically unfit by the ICU physicians
- pregnant patients or breast feeding patients
- patients with specific pathologies that may impair respiratory muscle function and response to interventions independent of mechanical ventilation and critical care stay
- Patient who have undergone surgical intervention / repair of the diaphragm within 6 months of the trial, diaphragm / hemi-diaphragm paralysis,
- patients unable to consent / collaborate in treatment,
- patients may also be excluded if the ICU physician deems the short disconnection period from MV is unsuitable,
- patients for palliative management or unlikely to survive their critical care episode.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is a Combined Respiratory Muscle Training Intervention, Incorporating Inspiratory and Expiratory Muscle Training, Feasible in Adult Critical Care Patients? A Single Arm Feasibility Trial.
Background: Respiratory muscle weakness is a recognised consequence of mechanical ventilation in critical care. This weakness can have implications for patients, leading to prolonged mechanical ventilation (MV) and intensive care unit (ICU) length of stay (LOS), with worse mortality and morbidity outcomes. The aim of this trial is to assess the safety and feasibility of a combined respiratory muscle training (RMST) intervention for respiratory muscle strengthening, in adult critical care patients receiving or recently liberated from mechanical ventilation.
Methods: This prospective single-arm feasibility study will be conducted in Tallaght University Hospital (TUH) ICU. Ethical approval will be sought from TUH ethics committee with sponsorship from (RCSI) Royal College of Surgeons Ireland. Informed consent will be sought from all eligible patients. Participants will receive a combined RMST intervention in addition to usual care. The primary feasibility outcomes of recruitment, adherence and retention will be reported. Secondary clinical outcomes of respiratory muscle strength (maximal inspiratory / expiratory pressure) and cough strength (peak cough flow) will be assessed at recruitment and weekly up to week three. Therapist perception of service usability will be assessed using the service usability survey.
- Conditions
- Critical Illness Myopathy, Critical Illness
- Being tested
- Combined respiratory muscle training, incorporating both inspiratory and expiratory muscle training
- Keywords
- inspiratory muscle training, expiratory muscle strength training, respiratory muscle training
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined respiratory muscle training, incorporating both inspiratory and expiratory muscle trainingOther
Also called IMT, EMST, RMST
IMT: Inspiratory Muscle Training EMST: Expiratory Muscle Strength Training RMST: Respiratory Muscle Strength Training In this trial we are combining both IMT and EMST in the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Single arm feasibility of combined respiratory muscle training | Experimental | The participants will undergo a combined respiratory muscle training intervention including both inspiratory and expiratory muscle training. Receives: Other: Combined respiratory muscle training, incorporating both inspiratory and expiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate Retention and Adherence Rates
The primary outcome measure for this trial are feasibility outcomes:
Recruitment rate will be calculated by dividing the number recruited by total number of eligible patients identified and multiplying by 100.
Measured: Up to 2 years
Retention Rates
Retention rate will be described as the percentage of patients with follow up data available
Measured: Up to 2 years
Adherence Rates
Adherence rate will be measured as the number of total treatment sessions divided by the number of potential total sessions, multiplied by 100.
Measured: Up to 2 years
Secondary outcomes (4)
Service Usability Scale.
Staff acceptability of delivering the intervention will assessed using the service usability scale. The scale assess's ten domains of service usability with a score of 1 to 5 denoting strong disagreement (1) up to strong agreement (5)
Measured: Up to 2 years
Inspiratory Muscle Strength
Inspiratory muscle strength will be assessed using Maximal Inspiratory Pressure (MIP): Clinical variability in maximal inspiratory pressure in response to intervention. This will be measured in cmH2O
Measured: Up to 2 years
Expiratory Muscle Strength
Expiratory muscle strength will be assessed using Maximal Expiratory Pressure (MEP). Clinical variability in clinical markers of maximal expiratory pressure in response to intervention. This will be measured in cmH2O
Measured: Up to 2 years
Cough strength
Peak Cough Flow (PCF) will be used to assess cough strength: Clinical variability in peak cough flow will be measured in response to intervention. This measurement unit is L/min.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Oct 2024
- Primary completion28 Feb 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Illness MyopathyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm feasibility design
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Tallaght University Hospital
- Responsible party
- Sponsor
- Investigators
- Eimear McCormack, Principal investigator, Tallaght University Hospital & Royal College of Surgeons IrelandYvelynne Kelly, Doctor, Principal investigator, Tallaght University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055789
- Sponsor's protocol ID
- 4331
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is a Combined Respiratory Muscle Training Intervention, Incorporating Inspiratory and Expiratory Muscle Training, Feasible in Adult Critical Care Patients? A Single Arm Feasibility Trial.
- ClinicalTrials.gov ID
- NCT07055789
- Acronym / sponsor ID
- 4331
- Conditions
- Critical Illness Myopathy, Critical Illness
- Keywords
- inspiratory muscle training, expiratory muscle strength training, respiratory muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- Tallaght University Hospital
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 9 Jul 2025 (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.
Background: Respiratory muscle weakness is a recognised consequence of mechanical ventilation in critical care. This weakness can have implications for patients, leading to prolonged mechanical ventilation (MV) and intensive care unit (ICU) length of stay (LOS), with worse mortality and morbidity outcomes. The aim of this trial is to assess the safety and feasibility of a combined respiratory muscle training (RMST) intervention for respiratory muscle strengthening, in adult critical care patients receiving or recently liberated from mechanical ventilation.
Methods: This prospective single-arm feasibility study will be conducted in Tallaght University Hospital (TUH) ICU. Ethical approval will be sought from TUH ethics committee with sponsorship from (RCSI) Royal College of Surgeons Ireland. Informed consent will be sought from all eligible patients. Participants will receive a combined RMST intervention in addition to usual care. The primary feasibility outcomes of recruitment, adherence and retention will be reported. Secondary clinical outcomes of respiratory muscle strength (maximal inspiratory / expiratory pressure) and cough strength (peak cough flow) will be assessed at recruitment and weekly up to week three. Therapist perception of service usability will be assessed using the service usability survey.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm feasibility design
| Arm | Type | Receives |
|---|---|---|
| Single arm feasibility of combined respiratory muscle training | Experimental | Other: Combined respiratory muscle training, incorporating both inspiratory and expiratory muscle trainingThe participants will undergo a combined respiratory muscle training intervention including both inspiratory and expiratory muscle training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥18years,
- mechanically ventilated for ≥ 24 hours,
- able to initiate spontaneous breaths on MV,
- on suitable levels of respiratory support with ≤.6 FiO2, ≤10 PEEP,
- deemed eligible for MV weaning by ICU consultant or recently extubated (<48 hours),
Key exclusion criteria (7 listed)
- patients deemed medically unfit by the ICU physicians
- pregnant patients or breast feeding patients
- patients with specific pathologies that may impair respiratory muscle function and response to interventions independent of mechanical ventilation and critical care stay
- Patient who have undergone surgical intervention / repair of the diaphragm within 6 months of the trial, diaphragm / hemi-diaphragm paralysis,
- patients unable to consent / collaborate in treatment,
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 |
|---|---|---|
| Combined respiratory muscle training, incorporating both inspiratory and expiratory muscle trainingAlso: IMT, EMST, RMSTIMT: Inspiratory Muscle Training EMST: Expiratory Muscle Strength Training RMST: Respiratory Muscle Strength Training In this trial we are combining both IMT and EMST in the intervention group. | Other | Single arm feasibility of combined respiratory muscle training |
Primary outcome
Recruitment Rate Retention and Adherence Rates
Time frame: Up to 2 years
The primary outcome measure for this trial are feasibility outcomes: Recruitment rate will be calculated by dividing the number recruited by total number of eligible patients identified and multiplying by 100.
Retention Rates
Time frame: Up to 2 years
Retention rate will be described as the percentage of patients with follow up data available
Adherence Rates
Time frame: Up to 2 years
Adherence rate will be measured as the number of total treatment sessions divided by the number of potential total sessions, multiplied by 100.
4 secondary outcomes
Service Usability Scale.
Time frame: Up to 2 years
Inspiratory Muscle Strength
Time frame: Up to 2 years
Expiratory Muscle Strength
Time frame: Up to 2 years
Cough strength
Time frame: Up to 2 years
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 17 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Eimear McCormack principal investigator
Tallaght University Hospital & Royal College of Surgeons Ireland
Yvelynne Kelly, Doctor principal investigator
Tallaght University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined respiratory muscle training, incorporating both inspiratory and expiratory muscle training in people with Critical Illness Myopathy and Critical Illness, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
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 6 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 17 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 Ireland. 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?
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?
Recruitment Rate Retention and Adherence Rates (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2026.