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Respiratory Muscle Training in ICU Patients

Inspiratory and Expiratory Muscle Training in Critically Ill Patients Weaned From Mechanical Ventilation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04507451
Enrollment
100
Registered
2020-08-11
Start date
2020-10-01
Completion date
2023-09-01
Last updated
2020-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Inspiratory Muscle Strength, Mechanical Ventilation, Respiratory Muscle Training

Brief summary

Respiratory muscle weakness is common after mechanical ventilation and occurs early. This can limit functional recovery. Respiratory muscle training is often neglected in clinical practice. Some data indicates that inspiratory muscle training increases inspiratory muscle strength and quality of life. The aim of the study is to assess the impact of combined inspiratory and expiratory muscle training on inspiratory muscle strength. The second aim is to assess the impact of this training program on expiratory muscle strength.

Interventions

PROCEDUREinspiratory and expiratory muscle training

inspiratory muscle training using threshold IMT device expiratory muscle training using a bottle filled of water

PROCEDUREinspiratory and expiratory exercises

inspiratory exercise using fractionated inspirations expiratory exercise using a bottle filled with water at a minimum level

Sponsors

University of Liege
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

patients are masked: they will all benefit from respiratory physiotherapy, with placebo or real muscle training investigator and care providers are unmasked, as they set the training parameters

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patient from mechanical ventilation after at least 24 hours of support * collaborative patient

Exclusion criteria

* confusion, mental disorder * not french speaking * pulmonary surgery in the past 12 months * external ventricular drain * previous pneumothorax or pneumothorax not drained * rib fractures * alveolar hemorrhage * hemodynamic instability * labial occlusion impossible (face burn, facial paralysis) * patient refusal

Design outcomes

Primary

MeasureTime frameDescription
change in inspiratory muscle strengthbetween 7 to 15 days after ICU discharge (compared to ICU discharge)measurement of maximal inspiratory pressure

Secondary

MeasureTime frameDescription
change in expiratory muscle strengthbetween 7 to 15 days after ICU discharge (compared to ICU discharge)measurement of maximal expiratory pressure
respiratory infections1 month after ICU dischargenumber of respiratory infections requiring antibiotics after ICU discharge
change in dyspnea perception1 month after ICU discharge (compared to hospital discharge)assessed using Dyspnea-12 questionnaire (score from 0 to 36, 36 indicating a maximal dyspnea)
impact of dyspnea on physical activitiesbetween 7 to 15 days after ICU dischargeassessed using modified Medical Research Council (m-MRC) score: stage 0 to 4 (last stage indicating a patient too dyspneic to leave house or breathless when dressing)

Countries

Belgium

Contacts

Primary ContactAnne-Françoise Rousseau, MD, PhD
afrousseau@chuliege.be+3243667495

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026