Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT01475812
Status:
COMPLETED
Last Update Posted:
2011-11-21
First Post:
2011-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Daily Activities Are Sufficient to Induce Dynamic Pulmonary Hyperinflation and Dyspnea in Chronic Obstructive Pulmonary Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000203', 'term': 'Activities of Daily Living'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'lastUpdateSubmitDate': '2011-11-18', 'studyFirstSubmitDate': '2011-11-17', 'studyFirstSubmitQcDate': '2011-11-18', 'lastUpdatePostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inspiratory capacity variability within the accomplishment of activities of daily living in COPD patients.', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'activities of daily living', 'pulmonary hyperinflation', 'exercise'], 'conditions': ['Dynamic Lung Hyperinflation', 'COPD Patients', 'Activities of Daily Livin.']}, 'descriptionModule': {'briefSummary': 'Introduction: Chronic obstructive pulmonary disease is a condition characterized by airflow limitation usually progressive and associated with inflammatory response of lung noxious particles. During a physical activity chronic obstructive pulmonary disease patients may develop dynamic pulmonary hyperinflation, increased dyspnea perception and decreased activity performance. The investigators hypothesize that some specific activities of daily living induce dynamic pulmonary hyperinflation in COPD patients. Objective: To measure dynamic lung hyperinflation and its influence in dyspnea perception in moderate and severe chronic obstructive pulmonary disease patients after activities of daily living. Methods: The investigators measured inspiratory capacity, dyspnea sensation, peripheral oxygen saturation, heart rate and respiratory rate in 19 chronic obstructive pulmonary disease (COPD) patients. These measurements were taken at rest and after daily living activities (such as going up and down a set of stairs, going up and down a ramp and sweeping and mopping a room).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators included 19 COPD patients (13 male) with moderate to very severe degree of airway obstruction, with a mean post bronchodilator forced expiratory volume in the first second (FEV1) of 48.7 ± 7.1% predicted and mean age of 64.1 ± 5.3.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD patients diagnosed with moderate to very severe airway obstruction according to GOLD classification (9)\n* clinical stability with no clinical exacerbation during the previous 30 days prior to the beginning of the study and to sign an informed consent form\n\nExclusion Criteria:\n\n* Inability to perform the slow vital capacity maneuver\n* excessive perceived dyspnea during the test\n* arterial oxyhemoglobin saturation (SpO2) lower than 80% during activities and/or need of oxygen supplementation'}, 'identificationModule': {'nctId': 'NCT01475812', 'acronym': 'Hyperinflation', 'briefTitle': 'Daily Activities Are Sufficient to Induce Dynamic Pulmonary Hyperinflation and Dyspnea in Chronic Obstructive Pulmonary Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'orgStudyIdInfo': {'id': '0353/03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD hyperinflation', 'interventionNames': ['Other: Hyperinflation and ADL']}], 'interventions': [{'name': 'Hyperinflation and ADL', 'type': 'OTHER', 'description': 'Assessment of dynamic pulmonary hyperinflation during activities of daily living in COPD patients.', 'armGroupLabels': ['COPD hyperinflation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05414000', 'city': 'São Paulo', 'state': 'São Paulo/SP', 'country': 'Brazil', 'facility': 'Federal University of São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Antonio A.M. Castro', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}