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

NCT07055789 | Completed

• 1 other identifier: 4331
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

inspiratory muscle training; expiratory muscle strength training; respiratory muscle training

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 2 years

• Retention Rates

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

  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.

  Up to 2 years

Secondary Outcomes (4)

• Service Usability Scale.

  Up to 2 years

• Inspiratory Muscle Strength

  Up to 2 years

• Expiratory Muscle Strength

  Up to 2 years

• Cough strength

  Up to 2 years

Study Arms (1)

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.

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

Interventions

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.

Also known as: IMT, EMST, RMST

Single arm feasibility of combined respiratory muscle training

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Tallaght University Hospital: collaborator

Study Sites (1)

Tallaght University Hospital

Dublin, Tallaght, D24NR0A, Ireland

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eimear McCormack

  Tallaght University Hospital & Royal College of Surgeons Ireland

  PRINCIPAL INVESTIGATOR

• Yvelynne Kelly, Doctor

  Tallaght University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm feasibility design

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: July 9, 2025
• Study Start: October 1, 2024
• Primary Completion: February 28, 2026
• Study Completion: March 12, 2026
• Last Updated: March 17, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)