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.
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).
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:
1. Usual care group (Control)
2. 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:
1. Lung function test (pre and post bronchodilator) (baseline, 3 month, 6 month, 9 month
and 12 month)
2. 6 min walk test (baseline, 3 month, 6 month, 9 month and 12 month)
3. Body mass index measurement (baseline, 3 month, 6 month, 9 month and 12 month)
4. Modified Medical Research Council dyspnoea scale (MMRC)(baseline, 3 month, 6 month, 9
month and 12 month)
5. 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05102305 -
A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
|
||
Completed |
NCT01867762 -
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Recruiting |
NCT05562037 -
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
|
N/A | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03089515 -
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
|
N/A | |
Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
Recruiting |
NCT05552833 -
Pulmonary Adaptive Responses to HIIT in COPD
|
N/A | |
Recruiting |
NCT05835492 -
A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
|
||
Recruiting |
NCT05631132 -
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
|
N/A | |
Completed |
NCT03244137 -
Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
|
||
Not yet recruiting |
NCT03282526 -
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
|
N/A | |
Completed |
NCT02546700 -
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 2 | |
Withdrawn |
NCT04446637 -
Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD
|
Phase 3 | |
Completed |
NCT04535986 -
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
|
Phase 3 | |
Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
Completed |
NCT03295474 -
Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
|
||
Completed |
NCT03256695 -
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Withdrawn |
NCT04042168 -
Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
Completed |
NCT03414541 -
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Completed |
NCT02552160 -
DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
|