{ "FullStudy":{ "Rank":217874, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515709", "OrgStudyIdInfo":{ "OrgStudyId":"2011LF001H" }, "Organization":{ "OrgFullName":"Royal Brompton & Harefield NHS Foundation Trust", "OrgClass":"OTHER" }, "BriefTitle":"Is the Short Physical Performance Battery a Useful Outcome Measure in Chronic Obstructive Pulmonary Disease", "OfficialTitle":"Is the Short Physical Performance Battery a Useful Outcome Measure in Patients With Chronic Obstructive Pulmonary Disease ?" }, "StatusModule":{ "StatusVerifiedDate":"October 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"April 2011", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2018", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"October 2, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"October 3, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Royal Brompton & Harefield NHS Foundation Trust", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Medical Research Council", "CollaboratorClass":"OTHER_GOV" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Patients with Chronic Obstructive Lung Disease (COPD) often develop muscle problems, particularly in their legs which makes them more limited in what they can do. The Short Physical Performance Battery (SPPB) is a simple test of standing balance, usual walking speed and ability to stand from a chair. The SPPB may be a useful measure to predict leg function.\n\nThis study aims to evaluate whether the SPPB is comparable with current exercise tests used in COPD patients, and whether it is useful in predicting disability, death and health resource usage over time." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Pulmonary Disease, Chronic Obstructive", "Lung Diseases, Obstructive", "Pulmonary Emphysema", "Bronchitis, Chronic", "Lung Diseases", "Disease Progression" ] }, "KeywordList":{ "Keyword":[ "Cohort Studies", "Longitudinal Studies" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Cohort" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"445", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Chronic Obstructive Pulmonary Disease", "ArmGroupDescription":"Patients with a diagnosis of COPD" } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Mortality rate", "PrimaryOutcomeTimeFrame":"36 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Hospitalisation rate", "SecondaryOutcomeTimeFrame":"36 months" },{ "SecondaryOutcomeMeasure":"Healthcare resource usage", "SecondaryOutcomeTimeFrame":"36 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nDiagnosis of COPD\n\nExclusion Criteria:\n\nAny patient in whom mobility and lower limb function have been significantly affected by a neuromuscular cause (eg. motor neurone disease), severe peripheral vascular disease or amputation\nAny patient whom is deemed unsafe to exercise\nPatients unable to complete the SPPB, walking tests and leg strength assessments.", "HealthyVolunteers":"No", "Gender":"All", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] }, "StudyPopulation":"Any patient with a diagnosis of COPD.", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"William DC Man, MRCP PhD", "OverallOfficialAffiliation":"NIHR Respiratory Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Harefield Hospital", "LocationCity":"Harefield", "LocationZip":"UB9 6JH", "LocationCountry":"United Kingdom" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"7838189", "ReferenceType":"background", "ReferenceCitation":"Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995 Mar 2;332(9):556-61." },{ "ReferencePMID":"8126356", "ReferenceType":"background", "ReferenceCitation":"Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94." },{ "ReferencePMID":"28476882", "ReferenceType":"derived", "ReferenceCitation":"Nolan CM, Kon SSC, Patel S, Jones SE, Barker RE, Polkey MI, Maddocks M, Man WD. Gait speed and pedestrian crossings in COPD. Thorax. 2018 Feb;73(2):191-192. doi: 10.1136/thoraxjnl-2017-210173. Epub 2017 May 5." } ] } } }, "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":"D000011656", "ConditionMeshTerm":"Pulmonary Emphysema" },{ "ConditionMeshId":"D000001991", "ConditionMeshTerm":"Bronchitis" },{ "ConditionMeshId":"D000029481", "ConditionMeshTerm":"Bronchitis, Chronic" },{ "ConditionMeshId":"D000018450", "ConditionMeshTerm":"Disease Progression" },{ "ConditionMeshId":"D000004646", "ConditionMeshTerm":"Emphysema" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" },{ "ConditionAncestorId":"D000020969", "ConditionAncestorTerm":"Disease Attributes" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000001982", "ConditionAncestorTerm":"Bronchial Diseases" },{ "ConditionAncestorId":"D000012141", "ConditionAncestorTerm":"Respiratory Tract Infections" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M19143", "ConditionBrowseLeafName":"Disease Progression", "ConditionBrowseLeafAsFound":"Disease Progression", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9751", "ConditionBrowseLeafName":"Lung Diseases", "ConditionBrowseLeafAsFound":"Lung Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9753", "ConditionBrowseLeafName":"Lung Diseases, Obstructive", "ConditionBrowseLeafAsFound":"Lung Diseases, Obstructive", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M22033", "ConditionBrowseLeafName":"Pulmonary Disease, Chronic Obstructive", "ConditionBrowseLeafAsFound":"Pulmonary Disease, Chronic Obstructive", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M6395", "ConditionBrowseLeafName":"Emphysema", "ConditionBrowseLeafAsFound":"Emphysema", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13093", "ConditionBrowseLeafName":"Pulmonary Emphysema", "ConditionBrowseLeafAsFound":"Pulmonary Emphysema", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3849", "ConditionBrowseLeafName":"Bronchitis", "ConditionBrowseLeafAsFound":"Bronchitis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M22036", "ConditionBrowseLeafName":"Bronchitis, Chronic", "ConditionBrowseLeafAsFound":"Bronchitis, Chronic", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M21284", "ConditionBrowseLeafName":"Disease Attributes", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3840", "ConditionBrowseLeafName":"Bronchial Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13561", "ConditionBrowseLeafName":"Respiratory Tract Infections", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" } ] } } } } } }