Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-01-01 @ 1:26 PM
Study NCT ID:
NCT00391703
Status:
TERMINATED
Last Update Posted:
2010-11-11
First Post:
2006-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'whyStopped': 'enrolment difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-10', 'studyFirstSubmitDate': '2006-10-23', 'studyFirstSubmitQcDate': '2006-10-23', 'lastUpdatePostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The six-minute walking distance', 'timeFrame': '0, 1, 2 months'}], 'secondaryOutcomes': [{'measure': 'Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation', 'timeFrame': '1 month'}, {'measure': 'Inspiratory reserve volume (IRV), gasometry, dyspnea score', 'timeFrame': '0, 1, 2 months'}, {'measure': 'Measurement of voluntary maximum force and non cooperative force of the quadriceps', 'timeFrame': '0, 1, 2 months'}, {'measure': 'Area of quadriceps cross section measured with a scanner', 'timeFrame': '1, 2 months'}, {'measure': 'Quadriceps muscle mass', 'timeFrame': '0, 1, 2 months'}, {'measure': 'Quality of life: CFQ14, BDI-TDI questionnaires', 'timeFrame': '0, 1, 2 months'}, {'measure': 'Compliance with ergocycle rehabilitation', 'timeFrame': '1 month'}, {'measure': 'HOMA and QUICKI tests', 'timeFrame': '0, 1, 2 months'}, {'measure': 'Spirometry', 'timeFrame': '0, 1, 2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cystic fibrosis', 'mucoviscidosis', 'electrostimulation', 'retraining'], 'conditions': ['Cystic Fibrosis', 'Mucoviscidosis']}, 'referencesModule': {'references': [{'pmid': '11076386', 'type': 'BACKGROUND', 'citation': 'Pin I, Grenet D, Scheid P, Domblides P, Stern M, Hubert D. [Specific aspects and care of lung involvement in adults with cystic fibrosis]. Rev Mal Respir. 2000 Aug;17(3 Pt 2):758-78. French.'}, {'pmid': '10051246', 'type': 'BACKGROUND', 'citation': 'de Meer K, Gulmans VA, van Der Laag J. Peripheral muscle weakness and exercise capacity in children with cystic fibrosis. Am J Respir Crit Care Med. 1999 Mar;159(3):748-54. doi: 10.1164/ajrccm.159.3.9802112.'}, {'pmid': '14500260', 'type': 'BACKGROUND', 'citation': 'Selvadurai HC, Allen J, Sachinwalla T, Macauley J, Blimkie CJ, Van Asperen PP. Muscle function and resting energy expenditure in female athletes with cystic fibrosis. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1476-80. doi: 10.1164/rccm.200303-363OC. Epub 2003 Sep 18.'}, {'pmid': '8466121', 'type': 'BACKGROUND', 'citation': 'Lands LC, Heigenhauser GJ, Jones NL. Respiratory and peripheral muscle function in cystic fibrosis. Am Rev Respir Dis. 1993 Apr;147(4):865-9. doi: 10.1164/ajrccm/147.4.865.'}, {'pmid': '10995596', 'type': 'BACKGROUND', 'citation': 'Elkin SL, Williams L, Moore M, Hodson ME, Rutherford OM. Relationship of skeletal muscle mass, muscle strength and bone mineral density in adults with cystic fibrosis. Clin Sci (Lond). 2000 Oct;99(4):309-14.'}, {'pmid': '8539680', 'type': 'BACKGROUND', 'citation': 'de Meer K, Jeneson JA, Gulmans VA, van der Laag J, Berger R. Efficiency of oxidative work performance of skeletal muscle in patients with cystic fibrosis. Thorax. 1995 Sep;50(9):980-3. doi: 10.1136/thx.50.9.980.'}, {'pmid': '11069820', 'type': 'BACKGROUND', 'citation': 'Moser C, Tirakitsoontorn P, Nussbaum E, Newcomb R, Cooper DM. Muscle size and cardiorespiratory response to exercise in cystic fibrosis. Am J Respir Crit Care Med. 2000 Nov;162(5):1823-7. doi: 10.1164/ajrccm.162.5.2003057.'}, {'pmid': '22911373', 'type': 'DERIVED', 'citation': 'Vivodtzev I, Decorte N, Wuyam B, Gonnet N, Durieu I, Levy P, Cracowski JL, Cracowski C. Benefits of neuromuscular electrical stimulation prior to endurance training in patients with cystic fibrosis and severe pulmonary dysfunction. Chest. 2013 Feb 1;143(2):485-493. doi: 10.1378/chest.12-0584.'}]}, 'descriptionModule': {'briefSummary': 'This is an add-on, randomized, open label, clinical trial that evaluates the use of quadriceps electrostimulation as an additional retraining procedure in patients suffering from cystic fibrosis.', 'detailedDescription': 'Cystic fibrosis is an autosomal recessive genetic disease due to a mutation of the CFTR protein gene. The CFTR protein transports chloride ions (Cl-) across cell membranes in the lungs, pancreas, digestive tract, reproductive tract, and skin.\n\nCFTR mutation mainly leads to a dysfunction of the pulmonary system and pancreas exocrine function.\n\nSeveral studies showed that cystic fibrosis commonly induces a reduction of effort tolerance, peripheral muscular strength and work capacity.\n\nPatients suffering from cystic fibrosis with a high endurance capacity have a lower risk of poor prognosis. Those with a severe dyspnea have a higher benefit with a force training or a combined force and endurance training than with endurance training alone.\n\nWe propose to study the effect of a quadriceps electrostimulation program, performed prior to an endurance retraining program using a cycloergometer, in patients with cystic fibrosis associated with severe pulmonary dysfunction, to enhance their muscular performance and increase their adherence to the cycloergometer retraining program.\n\nThis is a randomized trial with two groups:\n\nGroup A: experimental group, twenty patients. Six weeks with electrostimulation program followed by six weeks under a cycloergometer program.\n\nGroup B: control group, twenty patients. Six weeks with their usual physical activity followed by six weeks with a cycloergometer program.\n\nThe Randomization is stratified on expiratory volume per second. The size of randomization blocks is random because of the open design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 years\n* Patient suffering from cystic fibrosis\n* Patient has at least three measures of maximum expiratory volume per second \\<= 45% of the theory among the 6 last measures performed\n* Affiliation to French social security\n* Capacity to consent\n\nExclusion Criteria:\n\n* Pregnant women\n* Contraindication to application of magnetic field\n* Pacemaker\n* History of neurosurgical intervention\n* Presence of metallic particles near the stimulation site.'}, 'identificationModule': {'nctId': 'NCT00391703', 'acronym': 'STIMUCO', 'briefTitle': 'Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Assessment of Quadriceps Muscle Electrostimulation Used as an Additional Procedure for Effort Retraining in Patients Suffering From Cystic Fibrosis Associated With Severe Pulmonary Dysfunction', 'orgStudyIdInfo': {'id': 'DCIC05/31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Quadriceps electrostimulation program, performed prior to an endurance retraining program using a cycloergometer', 'interventionNames': ['Behavioral: Electrostimulation programme: using a cycloergometer']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Usual sport activity, performed prior to an endurance retraining program using a cycloergometer', 'interventionNames': ['Behavioral: Usual sport activity']}], 'interventions': [{'name': 'Electrostimulation programme: using a cycloergometer', 'type': 'BEHAVIORAL', 'description': 'Quadriceps electrostimulation programme performed prior to an endurance retraining program using a cycloergometer, for 6 weeks, 60 to 90 minutes by session, 5 to 6 sessions per week', 'armGroupLabels': ['1']}, {'name': 'Usual sport activity', 'type': 'BEHAVIORAL', 'description': 'Usual sport activity performed prior to an endurance retraining program using a cycloergometer', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'state': 'Isere', 'country': 'France', 'facility': 'Pneumology Department of Grenoble University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '69000', 'city': 'Lyon', 'state': 'Rhone', 'country': 'France', 'facility': 'Pneumology Department of Lyon University Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Claire Cracowski, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pneumology Department of Grenoble University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vaincre la Mucoviscidose', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'M. Eric Svahn', 'oldOrganization': 'Clinical Research Department, Grenoble University Hospital'}}}}