Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 12:35 AM
Study NCT ID:
NCT00291460
Status:
UNKNOWN
Last Update Posted:
2006-08-21
First Post:
2006-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inspiratory Muscle Training in Hypercapnic COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], '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': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-02', 'completionDateStruct': {'date': '2008-03'}, 'lastUpdateSubmitDate': '2006-08-18', 'studyFirstSubmitDate': '2006-02-13', 'studyFirstSubmitQcDate': '2006-02-13', 'lastUpdatePostDateStruct': {'date': '2006-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'inspiratory muscle strength'}, {'measure': 'inspiratory muscle endurance'}, {'measure': 'walking distance with dyspnea score'}, {'measure': 'Carbon dioxide level'}]}, 'conditionsModule': {'keywords': ['COPD', 'respiratory failure', 'inspiratory muscle training'], 'conditions': ['COPD', 'Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'The trial intends to investigate, whether inspiratory muscle training in hypercapnic patients improves inspiratory muscle strength, inspiratory muscle endurance and endurance to walk within six minutes.', 'detailedDescription': 'Inspiratory muscle training is known to improve inspiratory muscle strength, inspiratory muscle endurance and walking distance within six minutes in patients with neuromuscular and thoraco-restrictive disease as well as in patients with COPD. Studies have only been conducted in patients without established respiratory failure. COPD patients with respiratory failure though are characterized by higher work rates of the inspiratory muscles and higher esophageal pressure swings compared to non-hypercapnic patients indication a discrepancy between muscle load and muscle capabilities. Therefore we hypothesize that for these patients training of their inspiratory muscles will be of benefit in terms of improvement of muscular and whole body endurance.\n\nDuring this investigation inspiratory muscle training will be applied in a randomized controlled fashion in 40 patients over a period of four weeks parallel to physical rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD with FEV1/FVC \\< 70 %\n* age \\> 18\n* stable disease\n* able to walk\n* carbon dioxide \\>= 48 mmHg\n\nExclusion Criteria:\n\n* ejection fraction of the heart \\< 40 %\n* active psychiatric disease\n* bronchial hyperresponsiveness according to ATS criteria\n* pregnancy\n* renal insufficiency with a creatinine \\< 2 mg/dl'}, 'identificationModule': {'nctId': 'NCT00291460', 'briefTitle': 'Inspiratory Muscle Training in Hypercapnic COPD', 'organization': {'class': 'OTHER', 'fullName': 'Krankenhaus Kloster Grafschaft'}, 'officialTitle': 'Randomized Controlled Trial of Inspiratory Muscle Training in Patients With Stable Hypercapnic Respiratory Failure Due to COPD', 'orgStudyIdInfo': {'id': 'FKKG IMT 0106'}}, 'armsInterventionsModule': {'interventions': [{'name': 'inspiratory muscle training', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '57392', 'city': 'Schmallenberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dominic Dellweg, M.D.', 'role': 'CONTACT', 'email': 'd.dellweg@fkkg.de', 'phone': '+49 2972', 'phoneExt': '1257'}, {'name': 'Dominic Dellweg, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Karina Reissig', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fachkrankenhaus Kloster Grafschaft', 'geoPoint': {'lat': 51.15473, 'lon': 8.28505}}], 'centralContacts': [{'name': 'Dominic Dellweg, M.D.', 'role': 'CONTACT', 'email': 'd.dellweg@fkkg.de', 'phone': '+49 2972 791', 'phoneExt': '1257'}], 'overallOfficials': [{'name': 'Dominic Dellweg, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FKKG'}, {'name': 'Dieter Koehler, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'FKKG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Krankenhaus Kloster Grafschaft', 'class': 'OTHER'}}}}