Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Long-term Evaluation of Activity and Health Status Pre and Post Pulmonary Rehabilitation - A Multi-Centred Trial.
NCT number | NCT00959855 |
Other study ID # | ITS-1-MCT |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2009 |
Est. completion date | September 2011 |
Verified date | July 2019 |
Source | Beaumont Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study has been designed to capture a large group of patients who undergo pulmonary
rehabilitation and map their progression over a 5 year time-frame.
The outcome measures have been chosen to capture physiological, functional capacity,
free-living activities plus admission and exacerbation rates thereby enhancing our
understanding of the potential effects exercise and self management techniques may have on
the disease progression.
Pulmonary rehabilitation has not been shown to reduce inflammation; therefore, unlike acute
exacerbation's where a decrease in inflammation indicates recovery, the exact mechanisms
responsible for improvement during pulmonary rehabilitation are as yet unknown.
Status | Completed |
Enrollment | 120 |
Est. completion date | September 2011 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. A diagnosis of COPD based on the GOLD staging of the Disease 2. MMRC score of 3 or above 3. Ability to mobilize independently 4. Willing to comply with the home exercise and inspiratory muscle training programmes 5. Willing to wear the SenseWare Armband 6. Optimal medical management 7. No adverse effects to exercise testing 8. Patient's awaiting lung transplant Exclusion Criteria: 1. Evidence of ischemic heart disease/acute changes on ECG 2. Uncontrolled hypertension 3. Insulin dependent diabetes mellitus 4. Uncontrolled CCF / idiopathic cardiomyopathy 5. Reversible Asthma 6. A diagnosis of lung cancer/TB/recent pneumothorax/PE or pneumonia 7. Any musculoskeletal/neurological condition which would render the patient incapable of completing the course 8. Exacerbation of COPD within 4 weeks of program 9. Poor cognitive status 10. Previous attendance at a pulmonary rehabilitation program |
Country | Name | City | State |
---|---|---|---|
Ireland | Beaumont Hospital | Beaumont | Dublin |
Lead Sponsor | Collaborator |
---|---|
Beaumont Hospital | ITS Pulmonary Rehabilitation Research Network |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of life score | St George's quality of life score at the end of one year will be compared between those who underwent rehabilitaion and those who were in the control non intervention group. | One year | |
Secondary | Spiromtery | Differences between the intervention group at 12 months . | 12 months | |
Secondary | Number of exacerbations of COPD. | The number of exacerbations of COPD will be compared between the control and the rehabilitation group. | over one year |
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