Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT01509235
Status:
COMPLETED
Last Update Posted:
2012-05-08
First Post:
2012-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self Drainage in Pediatric Cystic Fibrosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-07', 'studyFirstSubmitDate': '2012-01-10', 'studyFirstSubmitQcDate': '2012-01-11', 'lastUpdatePostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight of sputum that was expectorated', 'timeFrame': '12 months', 'description': 'The Physiotherapist collected all sputum excreted from the beginning of the session and during the first hour.'}], 'secondaryOutcomes': [{'measure': "patient's satisfaction", 'timeFrame': '12 months', 'description': "evaluation of FEV1 before and after the session, ii) sessions' quality (i.e. patients' cooperation), iii) patient's satisfaction. Patient's cooperation was quoted by the physiotherapist from 1 (patient refused to participate) to 5 (excellent participation). Patients' satisfaction was scored using a visual analogic scale (VAS) graduated from 0 (not satisfied at all) to 100 (totally satisfied)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cystic fibrosis', 'Lung function', 'physical exercise'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '23177226', 'type': 'DERIVED', 'citation': 'Reix P, Aubert F, Werck-Gallois MC, Toutain A, Mazzocchi C, Moreux N, Bellon G, Rabilloud M, Kassai B. Exercise with incorporated expiratory manoeuvres was as effective as breathing techniques for airway clearance in children with cystic fibrosis: a randomised crossover trial. J Physiother. 2012;58(4):241-7. doi: 10.1016/S1836-9553(12)70125-X.'}]}, 'descriptionModule': {'briefSummary': 'In the current study, we designed a cross-over, open label, randomized controlled clinical trial that aim to investigate the superiority of physical exercise coupled with self drainage to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children undergoing physical exercise coupled to self drainage will increase the amount of expectorate secretions compared to conventional CP course, while being more satisfied and without worsening their pulmonary function status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cystic fibrosis diagnosis confirmed by 2 positive sudoriparous diagnostic tests\n* Age : 7 to 17 years\n* Capacity to expectorate\n* Clinically stable\n* Ability to pedal on a bike and to respect orders for physical session\n\nExclusion Criteria:\n\n* Haemoptysis \\> 50ml\n* Permanent non-invasive ventilation\n* Respiration or digestive evolutive clinical abnormality\n* Exacerbation'}, 'identificationModule': {'nctId': 'NCT01509235', 'acronym': 'GYM-MUCO', 'briefTitle': 'Self Drainage in Pediatric Cystic Fibrosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial', 'orgStudyIdInfo': {'id': '2005.403'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1. Exercise testing and self drainage session', 'interventionNames': ['Procedure: Chest physiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2. Chest physiotherapy (CP) session', 'interventionNames': ['Procedure: Chest physiotherapy']}], 'interventions': [{'name': 'Chest physiotherapy', 'type': 'PROCEDURE', 'description': "The whole exercise session consisted of three short period of exercise of 5 minutes each entirely done under the physiotherapists' supervision (FA).", 'armGroupLabels': ['1. Exercise testing and self drainage session', '2. Chest physiotherapy (CP) session']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gabriel Bellon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}