Respiratory Muscle Training in ICU Patients

Not Applicable

• Conditions: Mechanical Ventilation; Respiratory Muscle Training; Inspiratory Muscle Strength; Critical Illness
• Interventions: Procedure: inspiratory and expiratory muscle training; Procedure: inspiratory and expiratory exercises

• Registration Number: NCT04507451
• Lead Sponsor: University of Liege

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-01
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-11
• Study Start: 2020-10-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trained group	inspiratory and expiratory muscle training	Patients will benefit from usual respiratory physiotherapy (secretion clearance treatment and recruitment maneuvers), and muscle training. This program will be delivered 5 days a week. Inspiratory muscle training (IMT): using a threshold IMT device with mouthpiece, 5 sets of 6 breaths, intensity is prescribed at 60% of maximal inspiratory pressure for the first set, and then increased to the highest tolerable intensity to allow completion of the 6th breath Expiratory muscle training (EMT): using a bottle filled with water, starting at 5cm and then increased to 8 cm gradually, 5 sets of 6 breaths Training program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge
Untrained group	inspiratory and expiratory exercises	Patients will benefit from usual respiratory physiotherapy (secretion clearance treatment and recruitment maneuvers), and muscle exercises that are not planned to train muscles. This program will be delivered 5 days a week. Inspiratory exercises: fractionated inspiration, 5 sets of 6 breaths Expiratory exercises: using a bottle filled with water (1 cm) Exercises program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge

Primary Outcome Measures

Name	Time	Method
change in inspiratory muscle strength	1 month after ICU discharge (compared to ICU discharge)	measurement of maximal inspiratory pressure

Secondary Outcome Measures

Name	Time	Method
change in expiratory muscle strength	1 month after ICU discharge (compared to ICU discharge)	measurement of maximal expiratory pressure
respiratory infections	1 month after ICU discharge	number of respiratory infections requiring antibiotics after ICU discharge
change in dyspnea perception	1 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 activities	1 month after ICU discharge	assessed 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)

Trial Locations

Locations (1)

University Hospital of Liège; 🇧🇪 Liège, Belgium