Early Pulmonary Rehabilitation for Hospitalized Patients With Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

NCT00287625 | Completed

• 1 other identifier: Resp/ko/2006/001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; Pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  Baseline, 3 months, 6 months, 9 months and 12 months

Secondary Outcomes (4)

• Lung function

  Baseline, 3 month, 6 month, 9 month and 12 month

• Dyspnoea score

  Baseline, 3 month, 6 month, 9 month and 12 month

• 6 minute walk distance

  Baseline, 3 month, 6 month, 9 month and 12 month

• Frequency of COPD exacerbation

  Baseline, 3 month, 6 month, 9 month and 12 month

Study Arms (2)

1

ACTIVE COMPARATOR

PRP

Procedure: Pulmonary rehabilitation

2

NO INTERVENTION

control

Interventions

Pulmonary rehabilitation PROCEDURE

Pulmonary rehabilitation

1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, N.t., 000, Hong Kong

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fanny WS Ko, MBChB

  CUHK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

HK (1)