Back to resultsRespiratory Muscle Training in ICU Patients
Primary Purpose
Critical Illness, Inspiratory Muscle Strength, Mechanical Ventilation
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
inspiratory and expiratory muscle training
inspiratory and expiratory exercises
Sponsored by
About this trial
This is an interventional prevention trial for Critical Illness
Eligibility Criteria
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
Sites / Locations
- University Hospital of LiègeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Trained group
Untrained group
Arm Description
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
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
Outcomes
Primary Outcome Measures
change in inspiratory muscle strength
measurement of maximal inspiratory pressure
change in inspiratory muscle strength
measurement of maximal inspiratory pressure
Secondary Outcome Measures
change in expiratory muscle strength
measurement of maximal expiratory pressure
change in expiratory muscle strength
measurement of maximal expiratory pressure
respiratory infections
number of respiratory infections requiring antibiotics after ICU discharge
change in dyspnea perception
assessed using Dyspnea-12 questionnaire (score from 0 to 36, 36 indicating a maximal dyspnea)
impact of dyspnea on physical activities
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)
impact of dyspnea on physical activities
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04507451
Brief Title
Respiratory Muscle Training in ICU Patients
Official Title
Inspiratory and Expiratory Muscle Training in Critically Ill Patients Weaned From Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Inspiratory Muscle Strength, Mechanical Ventilation, Respiratory Muscle Training
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
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
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trained group
Arm Type
Experimental
Arm Description
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
Arm Title
Untrained group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
inspiratory and expiratory muscle training
Intervention Description
inspiratory muscle training using threshold IMT device expiratory muscle training using a bottle filled of water
Intervention Type
Procedure
Intervention Name(s)
inspiratory and expiratory exercises
Intervention Description
inspiratory exercise using fractionated inspirations expiratory exercise using a bottle filled with water at a minimum level
Primary Outcome Measure Information:
Title
change in inspiratory muscle strength
Description
measurement of maximal inspiratory pressure
Time Frame
between 7 to 15 days after ICU discharge (compared to ICU discharge)
Title
change in inspiratory muscle strength
Description
measurement of maximal inspiratory pressure
Time Frame
1 month after ICU discharge (compared to ICU discharge)
Secondary Outcome Measure Information:
Title
change in expiratory muscle strength
Description
measurement of maximal expiratory pressure
Time Frame
between 7 to 15 days after ICU discharge (compared to ICU discharge)
Title
change in expiratory muscle strength
Description
measurement of maximal expiratory pressure
Time Frame
1 month after ICU discharge (compared to ICU discharge)
Title
respiratory infections
Description
number of respiratory infections requiring antibiotics after ICU discharge
Time Frame
1 month after ICU discharge
Title
change in dyspnea perception
Description
assessed using Dyspnea-12 questionnaire (score from 0 to 36, 36 indicating a maximal dyspnea)
Time Frame
1 month after ICU discharge (compared to hospital discharge)
Title
impact of dyspnea on physical activities
Description
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)
Time Frame
between 7 to 15 days after ICU discharge
Title
impact of dyspnea on physical activities
Description
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)
Time Frame
1 month after ICU discharge
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Françoise Rousseau, MD, PhD
Phone
+3243667495
Email
afrousseau@chuliege.be
Facility Information:
Facility Name
University Hospital of Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Françoise Rousseau, PhD
Phone
+3243667495
Email
afrousseau@chuliege.be
12. IPD Sharing Statement
Plan to Share IPD
No
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Respiratory Muscle Training in ICU Patients
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