Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-29 @ 5:55 AM
Study NCT ID:
NCT01218295
Status:
UNKNOWN
Last Update Posted:
2010-10-11
First Post:
2010-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inspiratory Muscle Training With Normocapnic Hyperpnea in Chronic Obstructive Pulmonary Disease (COPD)
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-10-08', 'studyFirstSubmitDate': '2010-10-07', 'studyFirstSubmitQcDate': '2010-10-08', 'lastUpdatePostDateStruct': {'date': '2010-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise Capacity', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'inspiratory muscles training'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'Many studies suggest that inspiratory muscles training by means of normocapnic hyperpnea improves exercise tolerance in healthy subjects. No information is available about the use of this training in COPD patients even if other methods (such as threshold loading and resistive loading) have been shown to be effective in terms of Inspiratory Muscle Function, Health-Related Quality of Life and Exercise Tolerance.\n\nThis study is designed to evaluate the effects of normocapnic hyperventilation by means of Spirotiger®, an instrument training the respiratory muscles, avoiding hypocapnia (using the methodology of isocapnic hyperpnoea)in COPD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD patients. All patients are at stable state, free from an exacerbation from at least 3 months.\n\nExclusion Criteria:\n\n* COPD patients with a recent history of cardiovascular disease, neurologic disease and other diseases that would interfere with the training.'}, 'identificationModule': {'nctId': 'NCT01218295', 'briefTitle': 'Inspiratory Muscle Training With Normocapnic Hyperpnea in Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Ferrara'}, 'officialTitle': 'Efficacy of Inspiratory Muscle Training by Means of Spirotiger® in COPD Patients.', 'orgStudyIdInfo': {'id': 'IMTCOPD2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Respiratory muscle training', 'description': 'Patients assigned to this arm train the respiratory muscles by means of normocapnic hyperpnea.', 'interventionNames': ['Device: Spirotiger®']}], 'interventions': [{'name': 'Spirotiger®', 'type': 'DEVICE', 'otherNames': ['Pulmonary rehabilitation'], 'description': 'training session :10 minutes twice a day X 4 weeks', 'armGroupLabels': ['Respiratory muscle training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44100', 'city': 'Ferrara', 'state': 'Ferrara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Annalisa Cogo, MD', 'role': 'CONTACT', 'email': 'cga@unife.it', 'phone': '+390532210420'}, {'name': 'Luca Pomidori, PhD', 'role': 'CONTACT', 'email': 'pmdlcu@unife.it', 'phone': '+390532455888'}], 'facility': 'Pulmonary Respiratory Unit- University Hospital', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}], 'centralContacts': [{'name': 'Annalisa Cogo, MD', 'role': 'CONTACT', 'email': 'cga@unife.it', 'phone': '+390532210420'}, {'name': 'Luca Pomidori, PhD', 'role': 'CONTACT', 'email': 'pmdlcu@unife.it', 'phone': '+390532455888'}], 'overallOfficials': [{'name': 'Annalisa Cogo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università di Ferrara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Ferrara', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Annalisa Cogo', 'oldOrganization': 'University of Ferrara'}}}}