Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-18 @ 1:30 PM
Study NCT ID:
NCT02656667
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2016-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a Pulmonary Rehabilitation Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2016-01-06', 'studyFirstSubmitQcDate': '2016-01-13', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional capacity of the lower limb muscles', 'timeFrame': '21 - 4 days / +7 days', 'description': 'Measure of the functional capacity of the lower limb muscles with the "1 minute Sit To Stand Test "'}], 'secondaryOutcomes': [{'measure': 'Maximal isometric voluntary quadriceps strength assessment', 'timeFrame': '21 - 4 days / +7 days', 'description': 'Quadriceps strength assessment with handheld dynamometer'}, {'measure': 'isometric voluntary quadriceps endurance assessment', 'timeFrame': '21 - 4 days / +7 days', 'description': 'Measure of isometric voluntary quadriceps endurance assessment with handheld dynamometer'}, {'measure': 'assessment of exercise capacity', 'timeFrame': '21 - 4 days / +7 days', 'description': 'Six minute walking test for assessing exercise capacity'}, {'measure': 'Quality of Life Assessment', 'timeFrame': '21 - 4 days / +7 days', 'description': 'COPD assessment test for assessing quality of life'}, {'measure': 'Dyspnea Assessment with Borg scale', 'timeFrame': '21 - 4 days / +7 days', 'description': 'Measure of dyspnea with Borg scale at the end of the six minute walking test'}, {'measure': 'Dyspnea Assessment with MRC Scale', 'timeFrame': '21 - 4 days / +7 days', 'description': 'Measure of dyspnea with Medical Research Council Dyspnea Scale'}, {'measure': 'Dyspnea Assessment with Dyspnea 12 questionnary', 'timeFrame': '21 - 4 days / +7 days', 'description': 'Measure of dyspnea with Dyspnea 12 questionnary'}, {'measure': 'Inspiratory capacity (in litres) by spirometry', 'timeFrame': '21 - 4 days / +7 days', 'description': 'Measure of inspiratory capacity (in litres) by spirometry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD pulmonary rehabilitation', 'neuromuscular electrical stimulation', 'sit to stand test COPD', 'quadriceps strengthening'], 'conditions': ['COPD']}, 'referencesModule': {'availIpds': [{'id': '22116795', 'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'type': 'Clinical Study Report', 'comment': 'Vivodtzev I, Debigaré R, Gagnon P, and al. Vivodtzev I, Debigaré R, Gagnon P, Mainguy V, Saey D, Dubé A, Paré MÈ, Bélanger M, Maltais F. Functional and muscular effects of neuromuscular electrical stimulation in patients with severe COPD: a randomized clinical trial. Chest. 2012 Mar;141(3):716-25.'}, {'id': '24418570', 'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'type': 'Clinical Study Report', 'comment': 'Vieira PJ, Chiappa AM, Cipriano G Jr, Umpierre D, Arena R, Chiappa GR. Neuromuscular electrical stimulation improves clinical and physiological function in COPD patients.Respir Med. 2014 Apr;108(4):609-20.'}, {'id': '23440837', 'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'type': 'Clinical Study Report', 'comment': 'Maddocks M, Gao W, Higginson IJ, Wilcock A.Neuromuscular electrical stimulation for muscle weakness in adults with advanced disease. Cochrane Database Syst Rev. 2013 Jan 31;1.'}, {'id': '16806873', 'url': 'http://www.ncbi.nlm.nih.gov/pubmed', 'type': 'Clinical Study Report', 'comment': 'Ozalevli S, Ozden A, Itil O, Akkoclu A. Comparison of the Sit-to-Stand Test with 6 min walk test in patients with chronic obstructive pulmonary disease. Respir Med 2007;101(2):286-93.'}], 'references': [{'pmid': '35404157', 'type': 'RESULT', 'citation': 'Peran L, Beaumont M, Le Ber C, Le Mevel P, Berriet AC, Nowak E, Consigny M, Couturaud F. Effect of neuromuscular electrical stimulation on exercise capacity in patients with severe chronic obstructive pulmonary disease: A randomised controlled trial. Clin Rehabil. 2022 Aug;36(8):1072-1082. doi: 10.1177/02692155221091802. Epub 2022 Apr 11.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer as part of pulmonary rehabilitation program , in patients with severe or very severe COPD , according to GOLD with BODE index ≥ 5 .', 'detailedDescription': "It's a prospective ,multicentre,randomised, single-blind study which compare the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer training as part of pulmonary rehabilitation program.\n\nThe program lasts from 3 to 4 weeks. 102 patients will included, diagnosed with COPD stages GOLD III and IV, and BODE index ≥ 5.\n\nThe commun program: training protocol performed on treadmill,quadriceps resistance training,patient therapeutic education,collective gymnastics,relaxation, session psychological care, smoking cessation program and nutritional management if necessary.\n\nThe primary criterion is the one minute sit to stand test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with COPD stage 3 or 4, with BODE index ≥ 5\n* Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix or in the center "Les Acacias" of briançon, with a 3 at 4 weeks pulmonary rehabilitation course;\n\nExclusion Criteria:\n\n* FEV ≥ 50%\n* Pneumonectomy, Lobectomy less than 6 months\n* Contraindications to muscle electrostimulation quadriceps\n* Absence of written consent\n* Inability to follow the respiratory rehabilitation program in its entirety\n* People equipped with electronic devices such as pacemakers and intracardiac defibrillators\n* Skin lesions and infectious foci on the electrode placement area.'}, 'identificationModule': {'nctId': 'NCT02656667', 'acronym': 'ESNM', 'briefTitle': 'Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a Pulmonary Rehabilitation Program', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a Pulmonary Rehabilitation Program', 'orgStudyIdInfo': {'id': 'ESNM (RB 15.058)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'neuromuscular electrical stimulation', 'description': 'conventional pulmonary rehabilitation including exercise training on treadmill and neuromuscular electrical stimulation with a medical device for quadriceps muscle strengthening', 'interventionNames': ['Device: neuromuscular electrical stimulation', 'Other: Conventional pulmonary rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'cycle ergometer training', 'description': 'conventional pulmonary rehabilitation including exercise training on treadmill and quadriceps strenghthening on cycle-ergometer', 'interventionNames': ['Device: cycle ergometer training', 'Other: Conventional pulmonary rehabilitation']}], 'interventions': [{'name': 'neuromuscular electrical stimulation', 'type': 'DEVICE', 'description': 'quadriceps strenghthening with neuromuscular electrical stimulation (medical device)', 'armGroupLabels': ['neuromuscular electrical stimulation']}, {'name': 'cycle ergometer training', 'type': 'DEVICE', 'description': 'quadriceps strenghthening with cycle ergometer training', 'armGroupLabels': ['cycle ergometer training']}, {'name': 'Conventional pulmonary rehabilitation', 'type': 'OTHER', 'description': 'excercise training on treadmill', 'armGroupLabels': ['cycle ergometer training', 'neuromuscular electrical stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05107', 'city': 'Briançon', 'state': 'France', 'country': 'France', 'facility': 'Centre des maladies respiratoires et allergiques - Les Acacias', 'geoPoint': {'lat': 44.89978, 'lon': 6.64201}}, {'zip': '29672', 'city': 'Morlaix', 'state': 'France', 'country': 'France', 'facility': 'CH de Morlaix', 'geoPoint': {'lat': 48.57784, 'lon': -3.82792}}], 'overallOfficials': [{'name': 'Francis Couturaud, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Brest'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}