Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-11 @ 12:56 AM
Study NCT ID:
NCT00592033
Status:
COMPLETED
Last Update Posted:
2012-03-22
First Post:
2007-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-21', 'studyFirstSubmitDate': '2007-12-31', 'studyFirstSubmitQcDate': '2007-12-31', 'lastUpdatePostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shuttle walk (endurance time)', 'timeFrame': '7 week, 3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'St. George Respiratory Questionnaire', 'timeFrame': '7 week, 3 and 6 months'}, {'measure': 'Usage of oxygen concentrator (Spent time according to the meter)', 'timeFrame': '7 weeks, 3 and 6 months'}, {'measure': 'Exacerbations requiring medical treatment (prednisolone or antibiotics)', 'timeFrame': '7 weeks, 3 and 6 months'}, {'measure': 'Hospitalisation', 'timeFrame': '7 weeks, 3 and 6 months'}, {'measure': 'Mortality', 'timeFrame': '7 weeks, 3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD oxygen', 'COPD rehabilitation', 'exercise'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'In COPD patients with desaturation during exercise, several studies have shown an acute beneficial effect of supplemental oxygen. Therefore, both the British Thoracic Society and the American Thoracic Society guidelines recommend supplemental oxygen to patients who desaturate \\>4% and to below 88-90%. However, long-term studies have not been able to support this intervention. In this study of COPD patients, who desaturate and participate in a 7-week pulmonary rehabilitation programme, we examine the effect of supplemental oxygen on exercise tolerance, health status, and exacerbation rates. In a randomised design patients trained either with room air or with 2 litres oxygen per minute from a portable oxygen concentrator. All patients were asked to exercise every day for 30 minutes.', 'detailedDescription': 'In COPD patients with desaturation during exercise, several studies have shown an acute beneficial effect of supplemental oxygen. Therefore, both the British Thoracic Society and the American Thoracic Society guidelines recommend supplemental oxygen to patients who desaturate \\>4% and to below 88-90%. However, long-term studies have not been able to support this intervention. In this study of COPD patients, who desaturate and participate in a 7-week pulmonary rehabilitation programme, we examine the effect of supplemental oxygen. Using a randomised design, patients trained either with room air (control) or with 2 litres oxygen per minute from a portable oxygen concentrator. All patients were asked to exercise every day for 30 minutes.\n\nPrimary effect parameters:\n\nendurance shuttle walk time at baseline, 7 weeks (after intensive supervised rehabilitation), 3 months (after maintenance training twice a month), and after 6 months.\n\nSecondary effect parameters:\n\nSt. George Respiratory Questionnaire (health status); usage of oxygen, exacerbations requiring medical treatment, hospitalisation and mortality in the same periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD\n* participate in a 7-weeks pulmonary rehabilitation programme\n* desaturate \\>4% to less than 90% during endurance shuttle walk test\n\nExclusion Criteria:\n\n* long-term oxygen therapy'}, 'identificationModule': {'nctId': 'NCT00592033', 'briefTitle': 'Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Effect of Ambulatory Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise. A Randomised Placebo Controlled Trial of Patients Who Participate in Pulmonary Rehabilitation', 'orgStudyIdInfo': {'id': '2007-41-0569'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Rehabilitation, no supplemental oxygen'}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Rehabilitation plus supplemental oxygen', 'interventionNames': ['Other: oxygen from a portable concentrator']}], 'interventions': [{'name': 'oxygen from a portable concentrator', 'type': 'OTHER', 'description': '2 l/minute during exercise', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'University Hospital, Hvidovre, Cardio-pulmonary depart.', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Thomas J Ringbaek, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hvidovre Hospital, University hospital, Cardio-pulmonary depart.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Lung Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant', 'investigatorFullName': 'Thomas Ringbaek', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}