Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-27 @ 3:28 AM
Study NCT ID:
NCT01649193
Status:
COMPLETED
Last Update Posted:
2014-11-05
First Post:
2012-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What is an Important Change in the Short Physical Performance Battery (SPPB)?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood taken and stored as whole blood, serum, and plasma.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-04', 'studyFirstSubmitDate': '2012-07-09', 'studyFirstSubmitQcDate': '2012-07-20', 'lastUpdatePostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of Short Physical Performance Battery', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline of MRC Dyspnoea Scale', 'timeFrame': '8 weeks'}, {'measure': "Change from baseline of St George's Respiratory Questionaire", 'timeFrame': '8 weeks'}, {'measure': 'Anchor question (5-point Likert scale)', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rehabilitation [E02.831]', 'Exercise [G11.427.394.380]', 'Health Education [I02.233.332]', '[C08]', '[C08.381]'], 'conditions': ['Respiratory Tract Diseases', 'Lung Diseases']}, 'referencesModule': {'references': [{'pmid': '1494764', 'type': 'BACKGROUND', 'citation': 'Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.'}, {'pmid': '1595997', 'type': 'BACKGROUND', 'citation': "Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321."}, {'pmid': '7838189', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1056/NEJM199503023320902.'}, {'pmid': '28476882', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the important change in the Short Physical Performance Battery (SPPB) when used in patients with lung disease. The SPPB is a simple physical test that measures balance and the functioning of the legs. It has been widely used in healthy elderly populations and predicts hospital admission and the onset of disability. The SPPB has not previously been used in patients with lung disease, and it is not clear what change in this test is considered meaningful and worthwhile by patients or doctors (the minimal clinically important difference: MID). Knowing what the MID for the SPPB will allow researchers and doctors to evaluate the effectiveness of current and new treatments, and to detect improvement or deterioration in the condition of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All chronic respiratory disease patients referred for pulmonary rehabilitation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients entering pulmonary rehabilitation\n\nExclusion Criteria:\n\n* Any patient in whom mobility and lower limb function have been significantly affected by a neuromuscular cause, severe peripheral vascular disease or amputation.\n* Any patient whom the chief investigator feels it is unsafe to exercise (e.g. unstable cardiac disease).'}, 'identificationModule': {'nctId': 'NCT01649193', 'briefTitle': 'What is an Important Change in the Short Physical Performance Battery (SPPB)?', 'organization': {'class': 'OTHER', 'fullName': 'Royal Brompton & Harefield NHS Foundation Trust'}, 'officialTitle': 'Determining the Minimal Important Difference of the Short Physical Performance Battery and 4m Gait Speed in Chronic Respiratory Disease Patients.', 'orgStudyIdInfo': {'id': '2012LF001H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Respiratory Disease', 'description': 'Any patient with a chronic respiratory disease referred for pulmonary rehabilitation', 'interventionNames': ['Other: Pulmonary rehabilitation']}], 'interventions': [{'name': 'Pulmonary rehabilitation', 'type': 'OTHER', 'description': 'An eight week out-patient based programme consisting of twice weekly supervised exercise and educational sessions', 'armGroupLabels': ['Chronic Respiratory Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'UB9 6JH', 'city': 'Harefield', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Harefield Hospital', 'geoPoint': {'lat': 51.60333, 'lon': -0.48546}}], 'overallOfficials': [{'name': 'William DC Man, MRCP, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Repiratory Biomedical Reserach Unit, Royal Brompton & Harefield NHS Foundation Trust and Imperial College London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Brompton & Harefield NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}