Short-course Out-patient Pulmonary Rehabilitation and COPD Exacerbations

January 31, 2019 updated by: Fanny W.S. Ko, Chinese University of Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • Prince of Wales Hospital
    • N.t.
      • Shatin, N.t., Hong Kong, 000
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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.
Behavioral: Physiotherapy
Pulmonary rehabilitation
No Intervention: Control group
The control group will receive no physiotherapy training by physiotherapist and no phone calls from case manager for reinforcement of home exercise. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospital readmissions
Time Frame: 12 months
The primary endpoint is the hospital readmissions
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life questionnaire
Time Frame: 12 months
12 months
Body mass index
Time Frame: 12 months
12 months
mortality
Time Frame: 12 months
12 months
Activity measure by the activity monitor
Time Frame: 12 months
12 months
lung function
Time Frame: 12 months
12 months
exercise capacities
Time Frame: 12 month
by 6 minute walk test
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Fanny WS Ko, MD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

June 8, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 15, 2015

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012 COPD care program_02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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