{ "FullStudy":{ "Rank":218032, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513616", "OrgStudyIdInfo":{ "OrgStudyId":"DMED-986-06" }, "Organization":{ "OrgFullName":"Queen's University", "OrgClass":"OTHER" }, "BriefTitle":"The Impact of Pulmonary Rehabilitation on Dyspnea in Chronic Obstructive Pulmonary Disease", "OfficialTitle":"Mechanisms of Dyspnea Relief Following Exercise Training in COPD" }, "StatusModule":{ "StatusVerifiedDate":"December 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 2006" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2011", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2011", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 11, 2012", "StudyFirstSubmitQCDate":"January 16, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"December 14, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 17, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Dr. Denis O'Donnell", "ResponsiblePartyInvestigatorTitle":"Principal Investigator", "ResponsiblePartyInvestigatorAffiliation":"Queen's University" }, "LeadSponsor":{ "LeadSponsorName":"Queen's University", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Dyspnea (respiratory discomfort) and activity limitation are the most common symptoms of chronic obstructive pulmonary disease (COPD) and contribute importantly to a perceived poor quality of life. Recent international guidelines have stressed the importance of dyspnea alleviation and improvement exercise tolerance as a means of enhancing quality of life and other long term outcomes in this population. Modern pharmacotherapy is the first step in symptom management but the overall impact of bronchodilator therapy is relatively small. Exercise training remains the most effective treatment for ameliorating dyspnea and improving exercise endurance and was the main focus of this study.\n\nThe main objectives of the study were:\n\nTo conduct and compare detailed studies of respiratory mechanics during cycle exercise before and after exercise training (EXT) compared with an untrained control group. By multiple regression analysis, the investigators will establish the main contributors to dyspnea relief after EXT.\nTo compare the magnitude of change in endurance during constant work rate cycle exercise with those measured during walk tests and the endurance shuttle walk test after EXT relative to control. To evaluate which test (constant work rate cycle, six-minute walk test, or endurance shuttle walk test) is the most sensitive test for measuring changes in endurance after EXT versus control.\nTo compare the change in standardized dyspnea ratings (Borg Scale) during constant-load cycling with a variety of other activity-related dyspnea questionnaires. To evaluate which of these measurements is the most sensitive for examining changes in perceived discomfort during exercise.\nTo evaluate the contribution of psychological factors (anxiety, fear, respiratory panic, self-efficacy) to the perceived improvement of symptoms following EXT. The investigators will use multiple regression analysis to examine associations between changes in perceived dyspnea and changes in anxiety and self-efficacy measured by validated questionnaires and Borg intensity ratings?" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Chronic Obstructive Pulmonary Disease" ] }, "KeywordList":{ "Keyword":[ "COPD", "dyspnea", "exercise", "measurement", "respiratory physiology" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"48", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Pulmonary rehabilitation", "ArmGroupType":"Experimental", "ArmGroupDescription":"A supervised 8-wk outpatient pulmonary rehabilitation program consisting of multi-modality exercise training and COPD self-management education.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Pulmonary rehabilitation" ] } },{ "ArmGroupLabel":"Usual care control", "ArmGroupType":"Sham Comparator", "ArmGroupDescription":"An 8-wk control period consisting of usual medical care which included optimization of respiratory medications, instructions on how best to manage COPD, standard access to treatment in the event of an exacerbation, self-management education.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Pulmonary rehabilitation", "Other: Usual care" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"Pulmonary rehabilitation", "InterventionDescription":"8-week program, 3 supervised session per week", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Pulmonary rehabilitation", "Usual care control" ] } },{ "InterventionType":"Other", "InterventionName":"Usual care", "InterventionDescription":"An 8-week control period (includes optimization of respiratory medications, instructions on how best to manage COPD, standard access to treatment in the event of an exacerbation, self-management education)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Usual care control" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Exertional dyspnea intensity", "PrimaryOutcomeDescription":"Post-intervention comparisons (pulmonary rehabilitation vs. usual care control) of dyspnea measurements (i.e., Borg ratings at a standardized time during high-intensity constant-work rate cycle exercise testing)", "PrimaryOutcomeTimeFrame":"8 weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Multidimensional measurements of dyspnea and physiological measurements", "SecondaryOutcomeDescription":"Activity-related dyspnea: MRC dyspnea scale, Transition Dyspnea Index, CRQ dyspnea component, SGRQ activity component", "SecondaryOutcomeTimeFrame":"8 weeks" },{ "SecondaryOutcomeMeasure":"Dyspnea-related anxiety", "SecondaryOutcomeDescription":"Intensity of dyspnea-related anxiety measured during cycle exercise testing (Borg scale)", "SecondaryOutcomeTimeFrame":"8 weeks" },{ "SecondaryOutcomeMeasure":"disease-specific self-efficacy", "SecondaryOutcomeDescription":"COPD Self-Efficacy Score", "SecondaryOutcomeTimeFrame":"8 weeks" },{ "SecondaryOutcomeMeasure":"Pulmonary function", "SecondaryOutcomeDescription":"Detailed measurements of pulmonary function: spirometry, body plethysmography, diffusing capacity, maximal respiratory pressures", "SecondaryOutcomeTimeFrame":"8 weeks" },{ "SecondaryOutcomeMeasure":"Cardiopulmonary exercise test measurements", "SecondaryOutcomeDescription":"Physiological measurements obtained during cycle exercise testing", "SecondaryOutcomeTimeFrame":"8 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\ndiagnosis of COPD\nclinically stable\npresence of activity-related dyspnea (Baseline Dyspnea Index < 9)\n40-80 years of age\n\nExclusion Criteria:\n\nother significant disorders or diseases that could interfere with conduct of the intervention or tests\nbody mass index < 18 or > 40 kg/m2", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"40 Years", "MaximumAge":"80 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Denis O'Donnell, MD, FRCPC", "OverallOfficialAffiliation":"Queen's University and Kingston General Hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Respiratory Investigation Unit at Kingston General Hospital", "LocationCity":"Kingston", "LocationState":"Ontario", "LocationZip":"K7L 2V7", "LocationCountry":"Canada" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000008171", "ConditionMeshTerm":"Lung Diseases" },{ "ConditionMeshId":"D000008173", "ConditionMeshTerm":"Lung Diseases, Obstructive" },{ "ConditionMeshId":"D000029424", "ConditionMeshTerm":"Pulmonary Disease, Chronic Obstructive" },{ "ConditionMeshId":"D000004417", "ConditionMeshTerm":"Dyspnea" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" },{ "ConditionAncestorId":"D000012120", "ConditionAncestorTerm":"Respiration Disorders" },{ "ConditionAncestorId":"D000012818", "ConditionAncestorTerm":"Signs and Symptoms, Respiratory" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M9751", "ConditionBrowseLeafName":"Lung Diseases", "ConditionBrowseLeafAsFound":"Pulmonary Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9753", "ConditionBrowseLeafName":"Lung Diseases, Obstructive", "ConditionBrowseLeafAsFound":"Obstructive Pulmonary Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M22033", "ConditionBrowseLeafName":"Pulmonary Disease, Chronic Obstructive", "ConditionBrowseLeafAsFound":"Chronic Obstructive Pulmonary Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M6174", "ConditionBrowseLeafName":"Dyspnea", "ConditionBrowseLeafAsFound":"Dyspnea", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13540", "ConditionBrowseLeafName":"Respiration Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14206", "ConditionBrowseLeafName":"Signs and Symptoms, Respiratory", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }