Chronic Obstructive Pulmonary Disease Clinical Trial
It has been shown, that in patients with very severe chronic obstructive pulmonary disease
(COPD) the additional use of non-invasive ventilation during pulmonary rehabilitation (PR)
may enhance the benefits of PR. It is assumed that the non-invasive ventilation techniques
provides a better recovery of the respiratory pump during the night. If non-invasive
ventilation also decreases the metabolic demands during night is unknown and is aim of this
study. During a 3 week inpatient pulmonary rehabilitation program a total of 85 patients with
chronic obstructive pulmonary disease stage IV will be recruited for this study. There will
be a 4:1 distribution into 2 groups. 68 patients with an indication for the use of a
non-invasive ventilation will be involved in the intervention group where non-invasive
ventilation will be initialized. 17 patients with chronic obstructive pulmonary disease stage
IV without an indication for the use of non-invasive ventilation will be involved in a
control group to detect the changes in nocturnal energy expenditure produced by pulmonary
rehabilitation alone. All outcome measurements will be performed during day 1-3 and will be
repeated after 12 days (with or without non-invasive ventilation) at day 15-17 of the
pulmonary rehabilitation program.
A sub-trial of this study is to validate night movement accuracy of the Dynaport activity
monitor with the observations made by a night-vision camera in the sleep lab. This will be
performed in study participants as well as in healthy volunteers.
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