Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-01 @ 11:37 AM
Study NCT ID:
NCT00881335
Status:
COMPLETED
Last Update Posted:
2012-06-29
First Post:
2009-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'xiangyu62@126.com', 'phone': '86-21-66307174', 'title': 'Zhang Xiangyu', 'organization': "Shanghai Tenth People's Hospital, Tongji University"}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group', 'description': 'all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'without any intervention', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'without any intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Cases With Antibiotics Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'without any intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 28 days', 'description': 'antibiotics therapy is the indicators of pulmonary infection', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'MPEF,Mean Peak Expiratory Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'without any intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '117.59', 'spread': '50.39', 'groupId': 'OG000'}, {'value': '103.93', 'spread': '41.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 28 days', 'description': 'indicators of pulmonary function, for example, PEF(unit of measurement:Liter per minute) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'FEV1, Forced Expiratory Volume at First Second', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'without any intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 28 days', 'description': 'indicators of pulmonary function, for example, FEV1(unit of measurement:Liter)\n\nAll subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'FVC, Forced Vital Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'without any intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '2.06', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 28 days', 'description': 'indicators of pulmonary function, for example, FVC(unit of measurement:Liter)\n\nAll subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'FEV1/FVC%, the Ratio of FEV1 to FVC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'without any intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '50.67', 'spread': '16.83', 'groupId': 'OG000'}, {'value': '59.04', 'spread': '13.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 28 days', 'description': 'indicators of pulmonary function,\n\nAll subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.', 'unitOfMeasure': 'ratios', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Cases With Hospital Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'without any intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group', 'description': 'all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'without any intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '3 participants did not complete the period', 'groupId': 'FG000', 'numSubjects': '27'}, {'comment': '2 participants did not complete the period', 'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'recuitment period: April 19th, May 17th location: Redsun geracomium'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group', 'description': 'all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'without any intervention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '86.81', 'spread': '2.06', 'groupId': 'BG000'}, {'value': '87.57', 'spread': '2.95', 'groupId': 'BG001'}, {'value': '87.20', 'spread': '2.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-25', 'studyFirstSubmitDate': '2009-04-14', 'resultsFirstSubmitDate': '2009-06-17', 'studyFirstSubmitQcDate': '2009-04-14', 'lastUpdatePostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-17', 'studyFirstPostDateStruct': {'date': '2009-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)', 'timeFrame': 'up to 28 days'}, {'measure': 'MPEF,Mean Peak Expiratory Flow', 'timeFrame': 'up to 28 days', 'description': 'indicators of pulmonary function, for example, PEF(unit of measurement:Liter per minute) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.'}, {'measure': 'FEV1, Forced Expiratory Volume at First Second', 'timeFrame': 'up to 28 days', 'description': 'indicators of pulmonary function, for example, FEV1(unit of measurement:Liter)\n\nAll subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.'}, {'measure': 'FVC, Forced Vital Capacity', 'timeFrame': 'up to 28 days', 'description': 'indicators of pulmonary function, for example, FVC(unit of measurement:Liter)\n\nAll subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.'}, {'measure': 'FEV1/FVC%, the Ratio of FEV1 to FVC', 'timeFrame': 'up to 28 days', 'description': 'indicators of pulmonary function,\n\nAll subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.'}], 'secondaryOutcomes': [{'measure': 'Number of Cases With Antibiotics Therapy', 'timeFrame': 'up to 28 days', 'description': 'antibiotics therapy is the indicators of pulmonary infection'}, {'measure': 'Number of Cases With Hospital Visit', 'timeFrame': 'up to 28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['geriatric', 'pulmonary disease', 'flutter', 'sputum', 'physical therapy techniques'], 'conditions': ['Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '20979671', 'type': 'DERIVED', 'citation': 'Wang QX, Zhang XY, Li Q. Effects of a flutter mucus-clearance device on pulmonary function test results in healthy people 85 years and older in China. Respir Care. 2010 Nov;55(11):1449-52.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices in elders of gerocomium.', 'detailedDescription': 'Respiratory diseases are still increasing in the elderly population. The fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but needs more clinical randomized, controlled trial evidence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '85 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* available to perform the device, the elders in geracomium\n* male and female\n* aging 85 years or more\n\nExclusion Criteria:\n\n* not available to perform the procedure\n* untreated pneumothorax\n* diffusion interstitial lung disease\n* acute coronary syndrome\n* third stage hypertension\n* advanced cancer\n* severe heart, liver, renal, blood system and endocrine system dysfunction\n* noninvasive mechanical ventilation\n* active hemoptysis'}, 'identificationModule': {'nctId': 'NCT00881335', 'briefTitle': 'Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function', 'organization': {'class': 'OTHER', 'fullName': 'Tongji University'}, 'officialTitle': 'Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function', 'orgStudyIdInfo': {'id': 'SHDC12007211-O'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group'}, {'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'Intervention group were given flutter valve mucus clearance devices to do pulmonary function exercise', 'interventionNames': ['Device: flutter mucus clearance device']}], 'interventions': [{'name': 'flutter mucus clearance device', 'type': 'DEVICE', 'description': 'five minutes every sessions, three sessions per day', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Zhang Xiangyu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai Tebth People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, director, professor, FCCM, FCCP.', 'investigatorFullName': 'Zhang Xiangyu', 'investigatorAffiliation': 'Tongji University'}}}}