Early Pulmonary Rehabilitation for Hospitalized Patients With Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
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).
|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 ]
|Study Start Date:||January 2006|
|Study Completion Date:||June 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Procedure: Pulmonary rehabilitation
No Intervention: 2
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287625
|Prince of Wales Hospital|
|Shatin, N.t., Hong Kong, 000|
|Principal Investigator:||Fanny WS Ko, MBChB||CUHK|