Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2026-01-04 @ 5:16 PM
Study NCT ID:
NCT02471235
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2015-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-course Out-patient Pulmonary Rehabilitation and COPD Exacerbations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2015-06-08', 'studyFirstSubmitQcDate': '2015-06-10', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hospital readmissions', 'timeFrame': '12 months', 'description': 'The primary endpoint is the hospital readmissions'}], 'secondaryOutcomes': [{'measure': 'Activity measure by the activity monitor', 'timeFrame': '12 months'}, {'measure': 'mortality', 'timeFrame': '12 months'}, {'measure': 'lung function', 'timeFrame': '12 months'}, {'measure': 'Body mass index', 'timeFrame': '12 months'}, {'measure': 'exercise capacities', 'timeFrame': '12 month', 'description': 'by 6 minute walk test'}, {'measure': 'Quality of life questionnaire', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Global initiative for chronic obstructive lung disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. 2013 http://www.goldcopd.org/uploads/users/files/GOLD_Report_2013_Feb20.pdf Access date: 28 Oct 2013.'}, {'pmid': '17765523', 'type': 'BACKGROUND', 'citation': 'Buist AS, McBurnie MA, Vollmer WM, Gillespie S, Burney P, Mannino DM, Menezes AM, Sullivan SD, Lee TA, Weiss KB, Jensen RL, Marks GB, Gulsvik A, Nizankowska-Mogilnicka E; BOLD Collaborative Research Group. International variation in the prevalence of COPD (the BOLD Study): a population-based prevalence study. Lancet. 2007 Sep 1;370(9589):741-50. doi: 10.1016/S0140-6736(07)61377-4.'}, {'pmid': '18544193', 'type': 'BACKGROUND', 'citation': 'Ko FW, Hui DS, Lai CK. Worldwide burden of COPD in high- and low-income countries. Part III. Asia-Pacific studies. Int J Tuberc Lung Dis. 2008 Jul;12(7):713-7.'}, {'pmid': '18945323', 'type': 'BACKGROUND', 'citation': 'Chan-Yeung M, Lai CK, Chan KS, Cheung AH, Yao TJ, Ho AS, Ko FW, Yam LY, Wong PC, Tsang KW, Lam WK, Ho JC, Chu CM, Yu WC, Chan HS, Ip MS, Hui DS, Tam CY; Hong Kong Thoracic Society. The burden of lung disease in Hong Kong: a report from the Hong Kong Thoracic Society. Respirology. 2008 Nov;13 Suppl 4:S133-65. doi: 10.1111/j.1440-1843.2008.01394.x.'}, {'pmid': '18684847', 'type': 'BACKGROUND', 'citation': 'Ko FW, Woo J, Tam W, Lai CK, Ngai J, Kwok T, Hui DS. Prevalence and risk factors of airflow obstruction in an elderly Chinese population. Eur Respir J. 2008 Dec;32(6):1472-8. doi: 10.1183/09031936.00058708. Epub 2008 Aug 6.'}, {'pmid': '17218555', 'type': 'BACKGROUND', 'citation': 'Ko FW, Ip M, Chan PK, Fok JP, Chan MC, Ngai JC, Chan DP, Hui DS. A 1-year prospective study of the infectious etiology in patients hospitalized with acute exacerbations of COPD. Chest. 2007 Jan;131(1):44-52. doi: 10.1378/chest.06-1355.'}, {'pmid': '17573516', 'type': 'BACKGROUND', 'citation': 'Ko FW, Ip M, Chan PK, Chan MC, To KW, Ng SS, Chau SS, Tang JW, Hui DS. Viral etiology of acute exacerbations of COPD in Hong Kong. Chest. 2007 Sep;132(3):900-8. doi: 10.1378/chest.07-0530. Epub 2007 Jun 15.'}, {'pmid': '17311838', 'type': 'BACKGROUND', 'citation': 'Ko FW, Tam W, Wong TW, Chan DP, Tung AH, Lai CK, Hui DS. Temporal relationship between air pollutants and hospital admissions for chronic obstructive pulmonary disease in Hong Kong. Thorax. 2007 Sep;62(9):780-5. doi: 10.1136/thx.2006.076166. Epub 2007 Feb 20.'}, {'pmid': '20655186', 'type': 'BACKGROUND', 'citation': 'Ko FW, Tam W, Tung AH, Ngai J, Ng SS, Lai K, Au KF, Hui DS. A longitudinal study of serial BODE indices in predicting mortality and readmissions for COPD. Respir Med. 2011 Feb;105(2):266-73. doi: 10.1016/j.rmed.2010.06.022. Epub 2010 Jul 22.'}, {'pmid': '14999112', 'type': 'BACKGROUND', 'citation': 'Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.'}, {'pmid': '12647946', 'type': 'BACKGROUND', 'citation': 'Halpern MT, Stanford RH, Borker R. The burden of COPD in the U.S.A.: results from the Confronting COPD survey. Respir Med. 2003 Mar;97 Suppl C:S81-9. doi: 10.1016/s0954-6111(03)80028-8.'}, {'pmid': '9603117', 'type': 'BACKGROUND', 'citation': 'Seemungal TA, Donaldson GC, Paul EA, Bestall JC, Jeffries DJ, Wedzicha JA. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998 May;157(5 Pt 1):1418-22. doi: 10.1164/ajrccm.157.5.9709032.'}, {'pmid': '10362051', 'type': 'BACKGROUND', 'citation': 'Donaldson GC, Seemungal T, Jeffries DJ, Wedzicha JA. Effect of temperature on lung function and symptoms in chronic obstructive pulmonary disease. Eur Respir J. 1999 Apr;13(4):844-9. doi: 10.1034/j.1399-3003.1999.13d25.x.'}, {'pmid': '15763452', 'type': 'BACKGROUND', 'citation': 'Ko FW, Ng TK, Li TS, Fok JP, Chan MC, Wu AK, Hui DS. Sputum bacteriology in patients with acute exacerbations of COPD in Hong Kong. Respir Med. 2005 Apr;99(4):454-60. doi: 10.1016/j.rmed.2004.09.011.'}, {'pmid': '16835422', 'type': 'BACKGROUND', 'citation': 'Manini TM, Everhart JE, Patel KV, Schoeller DA, Colbert LH, Visser M, Tylavsky F, Bauer DC, Goodpaster BH, Harris TB. Daily activity energy expenditure and mortality among older adults. JAMA. 2006 Jul 12;296(2):171-9. doi: 10.1001/jama.296.2.171.'}, {'pmid': '19276984', 'type': 'BACKGROUND', 'citation': 'Hamer M, Stamatakis E. Physical activity and mortality in men and women with diagnosed cardiovascular disease. Eur J Cardiovasc Prev Rehabil. 2009 Apr;16(2):156-60. doi: 10.1097/HJR.0b013e32831f1b77.'}, {'pmid': '21273294', 'type': 'BACKGROUND', 'citation': 'Waschki B, Kirsten A, Holz O, Muller KC, Meyer T, Watz H, Magnussen H. Physical activity is the strongest predictor of all-cause mortality in patients with COPD: a prospective cohort study. Chest. 2011 Aug;140(2):331-342. doi: 10.1378/chest.10-2521. Epub 2011 Jan 27.'}, {'pmid': '21124233', 'type': 'BACKGROUND', 'citation': 'Katz P, Chen H, Omachi TA, Gregorich SE, Julian L, Cisternas M, Balmes J, Blanc PD. The role of physical inactivity in increasing disability among older adults with obstructive airway disease. J Cardiopulm Rehabil Prev. 2011 May-Jun;31(3):193-7. doi: 10.1097/HCR.0b013e3181fc09b7.'}, {'pmid': '22815389', 'type': 'BACKGROUND', 'citation': 'van den Borst B, Slot IG, Hellwig VA, Vosse BA, Kelders MC, Barreiro E, Schols AM, Gosker HR. Loss of quadriceps muscle oxidative phenotype and decreased endurance in patients with mild-to-moderate COPD. J Appl Physiol (1985). 2013 May;114(9):1319-28. doi: 10.1152/japplphysiol.00508.2012. Epub 2012 Jul 19.'}, {'pmid': '32542906', 'type': 'DERIVED', 'citation': 'Ko FW, Tam W, Siu EHS, Chan KP, Ngai JC, Ng SS, Chan TO, Hui DS. Effect of short-course exercise training on the frequency of exacerbations and physical activity in patients with COPD: A randomized controlled trial. Respirology. 2021 Jan;26(1):72-79. doi: 10.1111/resp.13872. Epub 2020 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'This study assessed whether a short course pulmonary rehabilitation programme with periodic reinforcement exercise training and phone call reminders would help to increase physical activity in COPD patients and also decrease readmissions for AECOPD.', 'detailedDescription': 'Objectives: Chronic obstructive pulmonary disease (COPD) is a disease with significant morbidity and incurs heavy utilization of healthcare resources. The direct cost of hospital admissions related to COPD is the single largest source of expenditure in the public hospital system. This study assessed whether a short course pulmonary rehabilitation programme with periodic reinforcement exercise training and phone call reminders would help to increase physical activity in COPD patients and also decrease readmissions for AECOPD.\n\nHypothesis: The above programme can reduce readmissions for AECOPD\n\nDesign: Randomised control trial. Patients will be randomised to the intervention or usual care group\n\nSubjects: Patients discharged from hospital after an episode of acute exacerbation of COPD\n\nStudy instruments: Activity monitor, quality of life questionnaire\n\nInterventions: The Intervention group will receive a short course pulmonary rehabilitation training as out-patient in the physiotherapy department for 4-8 sessions, 2 hours each time, 1-2 times weekly. The training is scheduled in the way that each subject would have at least 4-8 weeks supervised training by trained physiotherapist. Home exercise will be taught and the case manager will give phone calls to the subject every 2 weeks to provide support and reinforcement for having continuous exercise at home for one year. Patients will be invited to attend reinforcement out-patient physiotherapy training once very month or every 2 months if they are willing to attend.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with COPD exacerbations\n\nExclusion Criteria:\n\n1. History of asthma, lung resection or other significant pulmonary disease like pulmonary fibrosis.\n2. Active infection like pulmonary tuberculosis\n3. Unable to complete assessment due to physical and/or cognitive impairment\n4. Completed a pulmonary rehabilitation program in the previous 24 months.\n5. Having short life expectancy like subjects with terminal malignancy or intractable heart failure'}, 'identificationModule': {'nctId': 'NCT02471235', 'briefTitle': 'Short-course Out-patient Pulmonary Rehabilitation and COPD Exacerbations', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Effect of Short Course Out-patient Pulmonary Rehabilitation on the Activity and Frequency of Exacerbations of Patients With Chronic Obstructive Pulmonary Disease.', 'orgStudyIdInfo': {'id': '2012 COPD care program_02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'The physiotherapist will provide every patient an individualized physical training programme that fits their cardiopulmonary status. Patients will have the training as out-patient in the physiotherapy department for 4-8 sessions, 2 hours each time, 1-2 times weekly. Home exercise will be taught. Our case manager will give phone calls to the subject every 2 weeks to provide support and reinforcement for having continuous exercise at home for one year. Patients will be invited to attend reinforcement out-patient physiotherapy training once very month or every 2 months if they are willing to attend.', 'interventionNames': ['Behavioral: Physiotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group will receive no physiotherapy training by physiotherapist and no phone calls from case manager for reinforcement of home exercise. .'}], 'interventions': [{'name': 'Physiotherapy', 'type': 'BEHAVIORAL', 'description': 'Pulmonary rehabilitation', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '000', 'city': 'Shatin', 'state': 'N.T.', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}, {'city': 'Shatin', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'overallOfficials': [{'name': 'Fanny WS Ko, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Honorary Associate Professor', 'investigatorFullName': 'Fanny W.S. Ko', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}