Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT04507451
Status:
UNKNOWN
Last Update Posted:
2020-11-04
First Post:
2020-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Respiratory Muscle Training in ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001239', 'term': 'Inhalation'}], 'ancestors': [{'id': 'D015656', 'term': 'Respiratory Mechanics'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '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'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2020-08-01', 'studyFirstSubmitQcDate': '2020-08-07', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in inspiratory muscle strength', 'timeFrame': 'between 7 to 15 days after ICU discharge (compared to ICU discharge)', 'description': 'measurement of maximal inspiratory pressure'}, {'measure': 'change in inspiratory muscle strength', 'timeFrame': '1 month after ICU discharge (compared to ICU discharge)', 'description': 'measurement of maximal inspiratory pressure'}], 'secondaryOutcomes': [{'measure': 'change in expiratory muscle strength', 'timeFrame': 'between 7 to 15 days after ICU discharge (compared to ICU discharge)', 'description': 'measurement of maximal expiratory pressure'}, {'measure': 'change in expiratory muscle strength', 'timeFrame': '1 month after ICU discharge (compared to ICU discharge)', 'description': 'measurement of maximal expiratory pressure'}, {'measure': 'respiratory infections', 'timeFrame': '1 month after ICU discharge', 'description': 'number of respiratory infections requiring antibiotics after ICU discharge'}, {'measure': 'change in dyspnea perception', 'timeFrame': '1 month after ICU discharge (compared to hospital discharge)', 'description': 'assessed using Dyspnea-12 questionnaire (score from 0 to 36, 36 indicating a maximal dyspnea)'}, {'measure': 'impact of dyspnea on physical activities', 'timeFrame': 'between 7 to 15 days after ICU discharge', '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)'}, {'measure': 'impact of dyspnea on physical activities', 'timeFrame': '1 month after ICU discharge', '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Illness', 'Inspiratory Muscle Strength', 'Mechanical Ventilation', 'Respiratory Muscle Training']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient from mechanical ventilation after at least 24 hours of support\n* collaborative patient\n\nExclusion Criteria:\n\n* confusion, mental disorder\n* not french speaking\n* pulmonary surgery in the past 12 months\n* external ventricular drain\n* previous pneumothorax or pneumothorax not drained\n* rib fractures\n* alveolar hemorrhage\n* hemodynamic instability\n* labial occlusion impossible (face burn, facial paralysis)\n* patient refusal'}, 'identificationModule': {'nctId': 'NCT04507451', 'briefTitle': 'Respiratory Muscle Training in ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Inspiratory and Expiratory Muscle Training in Critically Ill Patients Weaned From Mechanical Ventilation', 'orgStudyIdInfo': {'id': 'RESP-USI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trained group', '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.\n\nInspiratory 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\n\nTraining program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge', 'interventionNames': ['Procedure: inspiratory and expiratory muscle training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Untrained group', '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.\n\nInspiratory exercises: fractionated inspiration, 5 sets of 6 breaths Expiratory exercises: using a bottle filled with water (1 cm)\n\nExercises program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge', 'interventionNames': ['Procedure: inspiratory and expiratory exercises']}], 'interventions': [{'name': 'inspiratory and expiratory muscle training', 'type': 'PROCEDURE', 'description': 'inspiratory muscle training using threshold IMT device expiratory muscle training using a bottle filled of water', 'armGroupLabels': ['Trained group']}, {'name': 'inspiratory and expiratory exercises', 'type': 'PROCEDURE', 'description': 'inspiratory exercise using fractionated inspirations expiratory exercise using a bottle filled with water at a minimum level', 'armGroupLabels': ['Untrained group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Anne-Françoise Rousseau, PhD', 'role': 'CONTACT', 'email': 'afrousseau@chuliege.be', 'phone': '+3243667495'}], 'facility': 'University Hospital of Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'Anne-Françoise Rousseau, MD, PhD', 'role': 'CONTACT', 'email': 'afrousseau@chuliege.be', 'phone': '+3243667495'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of clinic', 'investigatorFullName': 'Rousseau', 'investigatorAffiliation': 'University of Liege'}}}}