Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
BACE Trial - Physical Activity as a Crucial Patient Reported Outcome in COPD
A first sub-analysis of the BACE trial will address physical activity levels in a subgroup of the intervention study with portable validated activity monitors.
Physical activity is strongly reduced with exacerbations and failure to increase physical
activity is associated with relapse. In addition, physical inactivity is known to be
associated with cardiovascular and metabolic morbidity and is one of the strongest predictors
of mortality in COPD. Apart from potential direct effects of the intervention on treatment
failure and symptoms, positive effects on physical activity may offer considerable benefits
in the long run.
Randomized patients that are willing to participate in the sub-study will be monitored for
activity by validated and easy-to-wear portable devices (Dynaport®). This activity monitor
was recently thoroughly validated for use in COPD by the Pro-Active consortium and will be
used at the baseline, 3 months and 9 months visit. We hypothesize that with a positive
medical intervention, differences in recovery of physical activity will be appreciated.
Patients will follow the standard protocol but will also wear the activity monitor for 7 days
post discharge from hospital (at investigator discretion), at day 90 (end of treatment) and
at day 270 (end of follow-up). This device is not only registering physical activity for 7
days but is also coupled to a standardized and patient-validated questionnaire on physical
activities which needs to be filled out at day 8 to cover a recall period of 7 (monitored)
days.
Patient will have to give informed consent for the additional measures that are related to
the activity sub-study. However, individual patients can still opt out for these tests
(sub-study) and only participate in the medical intervention study (main study).
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