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

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00287625
First received: February 6, 2006
Last updated: June 22, 2011
Last verified: June 2011
  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.

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287625

Locations
Hong Kong
Prince of Wales Hospital
Shatin, N.t., Hong Kong, 000
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Fanny WS Ko, MBChB CUHK
  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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014