Chronic Obstructive Pulmonary DiseaseNCT00287625
Early Pulmonary Rehabilitation for Hospitalized Patients With Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
A study testing Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pulmonary rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2006to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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).
Read the detailed description
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.5,17 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. Patients who have had PRP within the past 1 year will not be recruited for this study.
The subjects will be randomized to 2 groups:
- Usual care group (Control)
- PRP group
A random number generator will be used to assign whether the patient is to be in the control or PRP group. The computer programme will help to randomize subjects in equal opportunity in either group but taking into account 5 factors: age (< 70 years or ≥ 70 years),sex, length of hospital admission (< 7 days or ≥ 7 days), 6 minute walk test ( < 100 metres or ≥ 100 metres), and predicted FEV1 (< 30% or ≥ 30%). This method is adapted by the study of Man et al.
After recruitment in the AECOPD admission, baseline assessment will be done 24 hours before discharge from hospital. Each subject will then be followed up every 3 months after discharge for 1 year. For the intervention group, the PRP will start within 10 days of discharge from the hospital. Patients in the intervention group will attend the rehabilitation unit in our physiotherapy department on 3 half days per week for 6 weeks. In the first visit, the patient will be seen by a nurse specialist and offered smoking cessation counseling and inhaler technique will be reinforced. The nurse will also offer psychosocial support to the patient. The exercise sessions will be performed by 2 dedicated physiotherapists. Supervised exercise training includes use of treadmill, arm cycling, and arm and leg weight training will be provided with intensity adjusted by the physiotherapist based on the tolerability and physiological variables (oxygen saturation and heart rate) of the patient. Patients will also be advised to perform home exercises. The physiotherapist will also teach the patient on proper breathing techniques and how to cope with the daily activities.
For the control group, the patients will also be seen by the nurse specialist within 10 days of discharge from the hospital as in the PRP group. The patients will be offered smoking cessation advice and inhaler technique will be reinforced as in the PRP group. Both the control and PRP groups will be followed up every 3 months in our respiratory research clinic. The Standard medications (including inhaled corticosteroid if appropriate according to the GOLD guideline1) will be prescribed to the patients for management of COPD in both groups. Both the PRP group and control group will also be seen by nurse specialist in each visit for further education of the disease and counseling.
Assessments will be performed to monitor the patient's progress in both groups:
- Lung function test (pre and post bronchodilator) (baseline, 3 month, 6 month, 9 month and 12 month)
- 6 min walk test (baseline, 3 month, 6 month, 9 month and 12 month)
- Body mass index measurement (baseline, 3 month, 6 month, 9 month and 12 month)
- Modified Medical Research Council dyspnoea scale (MMRC)(baseline, 3 month, 6 month, 9 month and 12 month)
- St George's Respiratory Questionnaire (SGRQ), medical outcomes short form 36 questionnaire (SF-36) and chronic respiratory questionnaire(baseline, 3 months, 12 months)
Exacerbations (that required treatment with a course of oral steroid or antibiotics), AED department visits and hospitalization will be counted. Patient will be phone contacted to check for any mortality if the patient does not return for follow up.
Each patient will be asked to give informed consent and ethical committee approval will be obtained from the Joint The Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pulmonary rehabilitation
- Keywords
- Chronic obstructive pulmonary disease, Pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationProcedure or surgery
Pulmonary rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | PRP Receives: Procedure: Pulmonary rehabilitation |
| 2 | No intervention | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Measured: Baseline, 3 months, 6 months, 9 months and 12 months
Secondary outcomes (4)
Lung function
Measured: Baseline, 3 month, 6 month, 9 month and 12 month
Dyspnoea score
Measured: Baseline, 3 month, 6 month, 9 month and 12 month
6 minute walk distance
Measured: Baseline, 3 month, 6 month, 9 month and 12 month
Frequency of COPD exacerbation
Measured: Baseline, 3 month, 6 month, 9 month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Fanny WS Ko, MBChB, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287625
- Sponsor's protocol ID
- Resp/ko/2006/001
- Status last verified
- Jun 2011
- First submitted
- 6 Feb 2006
- Last updated
- 23 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00287625
- Acronym / sponsor ID
- Resp/ko/2006/001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, Pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.5,17 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. Patients who have had PRP within the past 1 year will not be recruited for this study.
The subjects will be randomized to 2 groups:
- Usual care group (Control)
- PRP group
A random number generator will be used to assign whether the patient is to be in the control or PRP group. The computer programme will help to randomize subjects in equal opportunity in either group but taking into account 5 factors: age (< 70 years or ≥ 70 years),sex, length of hospital admission (< 7 days or ≥ 7 days), 6 minute walk test ( < 100 metres or ≥ 100 metres), and predicted FEV1 (< 30% or ≥ 30%). This method is adapted by the study of Man et al.
After recruitment in the AECOPD admission, baseline assessment will be done 24 hours before discharge from hospital. Each subject will then be followed up every 3 months after discharge for 1 year. For the intervention group, the PRP will start within 10 days of discharge from the hospital. Patients in the intervention group will attend the rehabilitation unit in our physiotherapy department on 3 half days per week for 6 weeks. In the first visit, the patient will be seen by a nurse specialist and offered smoking cessation counseling and inhaler technique will be reinforced. The nurse will also offer psychosocial support to the patient. The exercise sessions will be performed by 2 dedicated physiotherapists. Supervised exercise training includes use of treadmill, arm cycling, and arm and leg weight training will be provided with intensity adjusted by the physiotherapist based on the tolerability and physiological variables (oxygen saturation and heart rate) of the patient. Patients will also be advised to perform home exercises. The physiotherapist will also teach the patient on proper breathing techniques and how to cope with the daily activities.
For the control group, the patients will also be seen by the nurse specialist within 10 days of discharge from the hospital as in the PRP group. The patients will be offered smoking cessation advice and inhaler technique will be reinforced as in the PRP group. Both the control and PRP groups will be followed up every 3 months in our respiratory research clinic. The Standard medications (including inhaled corticosteroid if appropriate according to the GOLD guideline1) will be prescribed to the patients for management of COPD in both groups. Both the PRP group and control group will also be seen by nurse specialist in each visit for further education of the disease and counseling.
Assessments will be performed to monitor the patient's progress in both groups:
- Lung function test (pre and post bronchodilator) (baseline, 3 month, 6 month, 9 month and 12 month)
- 6 min walk test (baseline, 3 month, 6 month, 9 month and 12 month)
- Body mass index measurement (baseline, 3 month, 6 month, 9 month and 12 month)
- Modified Medical Research Council dyspnoea scale (MMRC)(baseline, 3 month, 6 month, 9 month and 12 month)
- St George's Respiratory Questionnaire (SGRQ), medical outcomes short form 36 questionnaire (SF-36) and chronic respiratory questionnaire(baseline, 3 months, 12 months)
Exacerbations (that required treatment with a course of oral steroid or antibiotics), AED department visits and hospitalization will be counted. Patient will be phone contacted to check for any mortality if the patient does not return for follow up.
Each patient will be asked to give informed consent and ethical committee approval will be obtained from the Joint The Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Pulmonary rehabilitationPRP |
| 2 | No intervention | –control |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitationPulmonary rehabilitation | Procedure or surgery | 1 |
Primary outcome
Quality of Life
Time frame: Baseline, 3 months, 6 months, 9 months and 12 months
4 secondary outcomes
Lung function
Time frame: Baseline, 3 month, 6 month, 9 month and 12 month
Dyspnoea score
Time frame: Baseline, 3 month, 6 month, 9 month and 12 month
6 minute walk distance
Time frame: Baseline, 3 month, 6 month, 9 month and 12 month
Frequency of COPD exacerbation
Time frame: Baseline, 3 month, 6 month, 9 month and 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fanny WS Ko, MBChB principal investigator
CUHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: Baseline, 3 months, 6 months, 9 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.