Early Pulmonary Rehabilitation for Hospitalized Patients With Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
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Purpose
Chronic obstructive pulmonary disease (COPD) is a disease state characterized by airflow limitation that is not fully reversible. Acute exacerbation of COPD (AECOPD) with increasing symptoms like dyspnea, cough and sputum is the natural history of the disease and incurs significant burden to our health care system. In Hong Kong, COPD was the 5th leading cause of death, and accounted for at least 4% of all public hospital acute admissions in 2003. Previous studies have shown that pulmonary function and quality of life were adversely affected by frequent exacerbations. Strategies to decrease the heavy use of health care resources is urgently needed for the benefits of the patients and the society.
Pulmonary rehabilitation programme (PRP) is a multidisciplinary programme of care for patients with chronic respiratory impairment. In COPD patients, the programme can be tailored individually and can optimize each patient's physical and social performance and autonomy. Previous studies on patients with stable COPD found that a PRP including education and physical training could lead to statistically significant and clinically meaningful improvements in health related quality of life and exercise capacity.
COPD patients who just have experienced an episode of acute exacerbations are at high risk of developing another attack. There has been only one randomized controlled study looking at the effect of out-patient PRP for patients immediately after an exacerbation. It has shown that PRP immediately after an exacerbation was safe and improved the exercise capacity and the quality of life at 3 months. However, the follow up duration of the study was short and thus the effect of rehabilitation on recurrent exacerbations and hospitalizations is not assessed and this information is important.
The investigators would thus like perform a randomized controlled trial to assess if a short course (for 6 weeks) out-patient PRP for patients admitted to acute hospital for AECOPD could have a positive impact on the patients by decreasing their health care resources utilization (recurrent COPD exacerbations, hospitalizations and accident and emergency department [AED] attendance) and improving the quality of life of the patients over a period of 1 year. Patients will be randomized to either a control group or PRP intervention group.
It is hope that the information generated from this study will be able to give a guide to whether short course PRP is effective for the patient (in terms of quality of life) and the health care system (in terms of health care utilization).
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Pulmonary Disease |
Procedure: Pulmonary rehabilitation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | To Study the Effect of Early Pulmonary Rehabilitation on Exacerbations, Hospitalization Rates and Quality of Life in Patients Admitted to Hospital With Acute Exacerbation of Chronic Obstructive Pulmonary Disease. |
- Quality of Life [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ] [ Designated as safety issue: No ]
- Lung function [ Time Frame: Baseline, 3 month, 6 month, 9 month and 12 month ] [ Designated as safety issue: No ]
- Dyspnoea score [ Time Frame: Baseline, 3 month, 6 month, 9 month and 12 month ] [ Designated as safety issue: No ]
- 6 minute walk distance [ Time Frame: Baseline, 3 month, 6 month, 9 month and 12 month ] [ Designated as safety issue: No ]
- Frequency of COPD exacerbation [ Time Frame: Baseline, 3 month, 6 month, 9 month and 12 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2006 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
PRP
|
Procedure: Pulmonary rehabilitation
Pulmonary rehabilitation
|
|
No Intervention: 2
control
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients admitted with AECOPD will be recruited for the study. AECOPD will be defined when a patient with background COPD has at least two of the major symptoms (increased dyspnoea, increased sputum purulence, increased sputum amount) or one major and one minor symptom (nasal discharge/congestion, wheeze, sore throat, cough) for at least two consecutive days.
- Inclusion criteria include patients who are ambulatory (no major joint problem and no Class III or IV angina),
- patients agree to join exercise programme if offered, the forced expiratory volume in 1 second (FEV1) <70% predicted normal and an age of over 40 years old.
Exclusion Criteria:
- Patients who have had PRP within the past 1 year will not be recruited for this study.
- Patient who are unable or refuse to consent for the study will also be excluded.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr. Fanny WS Ko, The Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT00287625 History of Changes |
| Other Study ID Numbers: | Resp/ko/2006/001 |
| Study First Received: | February 6, 2006 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Hong Kong: Department of Health |
Keywords provided by Chinese University of Hong Kong:
|
Chronic obstructive pulmonary disease Pulmonary rehabilitation |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013