Chronic Obstructive Pulmonary Disease Clinical Trial
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.
Verified date | June 2011 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | Hong Kong: Department of Health |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 60 |
Est. completion date | June 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Shatin | N.t. |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of Life | Baseline, 3 months, 6 months, 9 months and 12 months | No | |
Secondary | Lung function | Baseline, 3 month, 6 month, 9 month and 12 month | No | |
Secondary | Dyspnoea score | Baseline, 3 month, 6 month, 9 month and 12 month | No | |
Secondary | 6 minute walk distance | Baseline, 3 month, 6 month, 9 month and 12 month | No | |
Secondary | Frequency of COPD exacerbation | Baseline, 3 month, 6 month, 9 month and 12 month | No |
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