Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-01-29 @ 4:56 AM
Study NCT ID:
NCT01747694
Status:
UNKNOWN
Last Update Posted:
2012-12-12
First Post:
2012-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Muscle Exercise Training in COPD Patients
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-10', 'studyFirstSubmitDate': '2012-12-10', 'studyFirstSubmitQcDate': '2012-12-10', 'lastUpdatePostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "St. George's Respiratory Questionnaire", 'timeFrame': 'three months', 'description': 'Disease-Specific quality of life'}, {'measure': 'CES-D', 'timeFrame': 'three months', 'description': 'assessment of depressive status'}], 'primaryOutcomes': [{'measure': 'PE max', 'timeFrame': 'three months', 'description': 'maximal strength of expiratory muscle'}], 'secondaryOutcomes': [{'measure': 'PI max', 'timeFrame': 'three months', 'description': 'maximal strength of inspiratory muscle'}, {'measure': '6MWT', 'timeFrame': 'three months', 'description': 'six-minute walking test'}, {'measure': 'MVV', 'timeFrame': 'three months', 'description': 'maximal voluntary volume'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD,Respiratory muscle training,Exercise tolerance'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'COPD patients often suffer from dyspnea and exercise intolerance which lower their quality of life.The aim of this proposed study is to examine the effectiveness of multi-respiratory muscle training on respiratory function of COPD patients.', 'detailedDescription': 'The respiratory muscle training is an important part of pulmonary rehabilitation. Subjects will be recruited from the chest medicine clinic of a medical center in Northern Taiwan, randomly assigned to control and experimental groups by severity status for a 12-week muscle training intervention.The outcome measures will be performed to evaluate respiratory function, depression status and quality of life at baseline, 4, 8 and 12 weeks of training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Chronic Obstructive Pulmonary Disease\n* Must be stable\n* Never participate in respiratory muscle trainig program\n\nExclusion Criteria:\n\n* Infection or acute excerbation condition\n* Abdominal surgical\n* Severe neuromuscular, cardiac disease or dementia'}, 'identificationModule': {'nctId': 'NCT01747694', 'briefTitle': 'Respiratory Muscle Exercise Training in COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'The Effectiveness of Multi-respiratory Muscle Training on Respiratory Function in Patients With COPD', 'orgStudyIdInfo': {'id': '101-2527A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multi-respiratory muscle training', 'description': 'Patients will perform multi-repiratory muscle training programe for 12 weeks', 'interventionNames': ['Behavioral: Multi-respiratory muscle training']}, {'type': 'NO_INTERVENTION', 'label': 'Diaphragmatic breathing', 'description': 'Patients will be taught diaphragmatic breathing technique routinely. To practice at home lasting 12 weeks'}], 'interventions': [{'name': 'Multi-respiratory muscle training', 'type': 'BEHAVIORAL', 'description': 'Patients will be taught the diaphragmatic breathing technique at the same time also will be instructed a four-item (including upper-arm weighted exercise, body side-bends, modified sit-ups, body crunching) multi-respiratory muscle training motions. To practice three times/day, three days a week lasting 12 weeks at home.', 'armGroupLabels': ['Multi-respiratory muscle training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shu-Chuan Ho, PhD', 'role': 'CONTACT', 'email': 'sc6212.ho@msa.hinet.net', 'phone': '+886-3-3281200', 'phoneExt': '5068'}], 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'centralContacts': [{'name': 'Shu-Chuan Ho, PhD', 'role': 'CONTACT', 'email': 'sc6212.ho@msa.hinet.net', 'phone': '+886+3+3281200', 'phoneExt': '5068'}], 'overallOfficials': [{'name': 'Shu-Chuan Ho, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chang Gung Memorial Hospital'}, {'name': 'Min-Fang Hsu, PhD student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Healthcare Administration,Asia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}