Chronic Obstructive Pulmonary Disease, Energy Expenditure, Non-invasive Ventilation, Pulmonary Rehabilitation
Conditions
Brief summary
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.
Interventions
patients will undergo a non-invasive ventilation during the night
Sponsors
Schön Klinik Berchtesgadener Land
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
for Intervention group: * chronic obstructive pulmonary disease stage IV * indication for the use of a nocturnal non-invasive ventilation (according to the German guidelines Schoenhofer et al. 2008) * patient has not yet used non-invasive ventilation at all or inadequately (less than 3 hours per day)
Exclusion criteria
for Intervention group: * acute exacerbation of chronic obstructive pulmonary disease * severe heart failure * body-mass-index \>35 m²/kg * fever Inclusion Criteria for control group: * chronic obstructive pulmonary disease stage IV (- healthy volunteers are also eligible for the sub-trial of this study to validate night movement accuracy of an activity monitor)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| energy expenditure during night | day 1-3 and day 14-16 | energy expenditure will be assessed by Sensewear Armband |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| energy expenditure during day | day 1-3 and day 14-16 | energy expenditure will be assessed by SenseWear Armband |
| lung function | day 1-3 and day 14-16 | measured by a bodyplethysmograph |
| sleep quality | day 1-3 and day 14-16 | measured by Severe Respiratory Insufficiency Questionnaire |
| arterial pressure of carbon dioxide during night | day 1-3 and day 14-16 | measured transcutaneously by a Sentec device |
| movement activity during the night | day 1 | night movement activity will be measured in a subgroup with the Dynaport device |
Countries
Germany
Contacts
Primary ContactKlaus Kenn, Dr.
Backup ContactRainer Gloeckl
Outcome results
None listed