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Completed

NCT Number: NCT07055789

Is Combined Respiratory Muscle Training, Incorporating Inspiratory and Expiratory Training, Feasible in Adult Critical-care Patients?

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.

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Key information

Conditions

Critical Illness Myopathy Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tallaght University Hospital

Dublin, Tallaght, D24NR0A, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Combined respiratory muscle training, incorporating both inspiratory and expiratory muscle training

Other

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.

Other names: IMT, EMST, RMST

Primary outcomes

  1. 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.

  2. Retention Rates

    Time frame: Up to 2 years

    Retention rate will be described as the percentage of patients with follow up data available

  3. 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.

Secondary outcomes

  1. Service Usability Scale.

    Time frame: Up to 2 years

    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)

  2. Inspiratory Muscle Strength

    Time frame: Up to 2 years

    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

  3. Expiratory Muscle Strength

    Time frame: Up to 2 years

    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

  4. Cough strength

    Time frame: Up to 2 years

    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.

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Collaborators

  • Tallaght University Hospital

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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