Short-course Out-patient Pulmonary Rehabilitation and COPD Exacerbations

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effect of Short Course Out-patient Pulmonary Rehabilitation on the Activity and Frequency of Exacerbations of Patients With Chronic Obstructive Pulmonary Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471235
• Other study ID #: 2012 COPD care program_02
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: November 2018

Study information

• Verified date: January 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Hypothesis: The above programme can reduce readmissions for AECOPD

Design: Randomised control trial. Patients will be randomised to the intervention or usual care group

Subjects: Patients discharged from hospital after an episode of acute exacerbation of COPD

Study instruments: Activity monitor, quality of life questionnaire

Interventions: 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: November 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Patients with COPD exacerbations

Exclusion Criteria:

1. History of asthma, lung resection or other significant pulmonary disease like pulmonary fibrosis.

2. Active infection like pulmonary tuberculosis

3. Unable to complete assessment due to physical and/or cognitive impairment

4. Completed a pulmonary rehabilitation program in the previous 24 months.

5. Having short life expectancy like subjects with terminal malignancy or intractable heart failure

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Physiotherapy
Pulmonary rehabilitation

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin	N.t.
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (19)

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. Erratum in: Lancet. 2012 Sep 1;380(9844):806. — View 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. — View 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. Erratum in: Respirology. 2009 Jan;14(1):150. — View Citation

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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.

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. — View 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. — View 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. — View 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. — View 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. Epub 2007 Jun 15. — View 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. — View 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. — View 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. — View 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. Epub 2007 Feb 20. — View 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. — View 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. — View 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. — View 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. — View Citation

Waschki B, Kirsten A, Holz O, Müller 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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospital readmissions	The primary endpoint is the hospital readmissions	12 months
Secondary	Activity measure by the activity monitor		12 months
Secondary	mortality		12 months
Secondary	lung function		12 months
Secondary	Body mass index		12 months
Secondary	exercise capacities	by 6 minute walk test	12 month
Secondary	Quality of life questionnaire		12 months