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.
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.
The benefits of pulmonary rehabilitation are well documented elsewhere, however, the exact
mechanisms responsible for these significant improvements and alteration of the disease
progression are unexplained. Also unexplained is the apparent lack of carry over of
functional capacity into free-living activities as measured by activity monitors.
There are no reported effects on decreasing level of inflammatory cytokines or C-reactive
protein (CRP) post rehabilitation, however, a training response to reactive oxidative stress
(ROS) after a moderate intensity pulmonary rehabilitation programme has been reported. As
oxidative stress is a catalyst to inflammation, a training response to exercise induced ROS
in patients with COPD may also have a secondary effect of modifying inflammation in the
stable COPD patient thereby improving patient outcomes.
No studies to-date have combined free-living activities, biomarkers and standard outcome
measures in patient's pre and post pulmonary rehabilitation or follow-up patients over a five
year period.
Subjects referred to pulmonary rehabilitation who fulfil the GOLD criteria for COPD will be
recruited on a rolling basis and randomly allocated to one of two groups. Group 1 (Control),
Group 2 (Intervention).
It is a multi-centred, randomised controlled trial using the above convenience sample of
patients referred to pulmonary rehabilitation who meet the inclusion/exclusion criteria.
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