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Short-course Out-patient Pulmonary Rehabilitation and COPD Exacerbations

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince of Wales Hospital
  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm 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.

The control group will receive no physiotherapy training by physiotherapist and no phone calls from case manager for reinforcement of home exercise. .

Outcomes

Primary Outcome Measures

hospital readmissions
The primary endpoint is the hospital readmissions

Secondary Outcome Measures

Activity measure by the activity monitor
mortality
lung function
Body mass index
exercise capacities
by 6 minute walk test
Quality of life questionnaire

Full Information

First Posted
June 8, 2015
Last Updated
January 31, 2019
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02471235
Brief Title
Short-course Out-patient Pulmonary Rehabilitation and COPD Exacerbations
Official Title
Effect of Short Course Out-patient Pulmonary Rehabilitation on the Activity and Frequency of Exacerbations of Patients With Chronic Obstructive Pulmonary Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive no physiotherapy training by physiotherapist and no phone calls from case manager for reinforcement of home exercise. .
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy
Intervention Description
Pulmonary rehabilitation
Primary Outcome Measure Information:
Title
hospital readmissions
Description
The primary endpoint is the hospital readmissions
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Activity measure by the activity monitor
Time Frame
12 months
Title
mortality
Time Frame
12 months
Title
lung function
Time Frame
12 months
Title
Body mass index
Time Frame
12 months
Title
exercise capacities
Description
by 6 minute walk test
Time Frame
12 month
Title
Quality of life questionnaire
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with COPD exacerbations Exclusion Criteria: History of asthma, lung resection or other significant pulmonary disease like pulmonary fibrosis. Active infection like pulmonary tuberculosis Unable to complete assessment due to physical and/or cognitive impairment Completed a pulmonary rehabilitation program in the previous 24 months. Having short life expectancy like subjects with terminal malignancy or intractable heart failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanny WS Ko, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
State/Province
N.t.
ZIP/Postal Code
000
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong

12. IPD Sharing Statement

Citations:
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.
Results Reference
background
PubMed Identifier
17765523
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. Erratum In: Lancet. 2012 Sep 1;380(9844):806.
Results Reference
background
PubMed Identifier
18544193
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.
Results Reference
background
PubMed Identifier
18945323
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.
Results Reference
background
PubMed Identifier
18684847
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.
Results Reference
background
PubMed Identifier
17218555
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.
Results Reference
background
PubMed Identifier
17573516
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.
Results Reference
background
PubMed Identifier
17311838
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.
Results Reference
background
PubMed Identifier
20655186
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.
Results Reference
background
PubMed Identifier
14999112
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.
Results Reference
background
PubMed Identifier
12647946
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.
Results Reference
background
PubMed Identifier
9603117
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.
Results Reference
background
PubMed Identifier
10362051
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.
Results Reference
background
PubMed Identifier
15763452
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.
Results Reference
background
PubMed Identifier
16835422
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.
Results Reference
background
PubMed Identifier
19276984
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.
Results Reference
background
PubMed Identifier
21273294
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.
Results Reference
background
PubMed Identifier
21124233
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.
Results Reference
background
PubMed Identifier
22815389
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.
Results Reference
background
PubMed Identifier
32542906
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.
Results Reference
derived

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Short-course Out-patient Pulmonary Rehabilitation and COPD Exacerbations

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