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Chronic Obstructive Pulmonary DiseaseNCT02471235

Short-course Out-patient Pulmonary Rehabilitation and COPD Exacerbations

A study testing Physiotherapy in people with Chronic Obstructive Pulmonary Disease, run by Chinese University of Hong Kong at 2 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
2 sitesHong Kong
Study dates
Jul 2015to Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with COPD exacerbations

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites

  • Prince of Wales Hospital

    Shatin, N.T., 000

  • Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

About this study

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

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.

Read the 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.

Being tested
Physiotherapy
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02471235
Study groupRoleWhat they receive
Intervention groupExperimentalThe 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.
Receives: Behavioral: Physiotherapy
Control groupNo interventionThe control group will receive no physiotherapy training by physiotherapist and no phone calls from case manager for reinforcement of home exercise. .

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hospital readmissions

    The primary endpoint is the hospital readmissions

    Measured: 12 months

Secondary outcomes (6)

  1. Activity measure by the activity monitor

    Measured: 12 months

  2. mortality

    Measured: 12 months

  3. lung function

    Measured: 12 months

  4. Body mass index

    Measured: 12 months

  5. exercise capacities

    by 6 minute walk test

    Measured: 12 month

  6. Quality of life questionnaire

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionSep 2018
  4. Study completionNov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02471235
Sponsor's protocol ID
2012 COPD care program_02
Status last verified
Jan 2019
First submitted
8 Jun 2015
Last updated
4 Feb 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

  • 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.

    PubMed 17765523

  • 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.

    PubMed 18544193

  • 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.

    PubMed 18945323

  • 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.

    PubMed 18684847

  • 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.

    PubMed 17218555

  • 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.

    PubMed 17573516

  • 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.

    PubMed 17311838

  • 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.

    PubMed 20655186

  • 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.

    PubMed 14999112

  • 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.

    PubMed 12647946

  • 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.

    PubMed 9603117

  • 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.

    PubMed 10362051

  • 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.

    PubMed 15763452

  • 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.

    PubMed 16835422

Questions about this trial

What is this clinical trial studying?

A study testing Physiotherapy in people with Chronic Obstructive Pulmonary Disease, run by Chinese University of Hong Kong at 2 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hospital readmissions (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02471235, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.

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