chronic obstructive pulmonary disease COPD exacerbations physiotherapy physical therapy counseling RCT cohort prognostic profiles chronisch obstructieve longziekten exacerbaties fysiotherapie prognostische profielen
Conditions
Interventions
Physiotherapy according to the latest KNGF guideline physiotherapy in COPD patients (2008) will be compared to usual care (counseling). Participants from the experimental group will receive care as us
Sponsors
Prof. dr. RA de Bie
Universiteit Maastricht
Eligibility
Inclusion criteria
Inclusion criteria: 1. COPD patients contacting a physiotherapist (within eight weeks after primary exacerbation), mostly but not exclusively, after visiting their general practitioner or pulmonologist because of an exacerbation, confirmed by general practitioner or pulmonologist; 2 - a: A general practitioner/pulmonologist diagnosed COPD in GOLD stage 2, 3 or 4 (confirmed by a post-bronchodilator FEV1/FVC < 0.7 and FEV1 < 80% of predicted). 2 - b: Eligible for reimbursement by health insurance companies for physical therapy (post-bronchodilator Tiffeneau-index < 0.6). 3. Known by their general practitioner of having an adequate and optimal medication (inhalation) regimen; 4. Motivated to collaborate both in the physiotherapy treatment and in the attainment of goals that will be established and need to sign informed consent; 5. Competent enough to speak and understand the Dutch language.
Exclusion criteria
Exclusion criteria: 1. COPD patients in GOLD stage 1 (supported by a post-bronchodilator FEV1 > 80% of predictive value). 2. Suffering from significant exercise limitations or co-morbidities that would prohibit a patient from following the physiotherapy program; 3. Patients who are expected to be lost for follow-up (e.g. because of a planned change of residency).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change 20-3-2016: The primary outcome is exacerbation frequency, the number of COPD exacerbations experienced by the patient. The initial primary outcome in the study protocol was listed as "time to exacerbation". However, the outcome exacerbation frequency is more informative seen the insight that a history of previously treated events is the best predictor of having frequent exacerbations. Moreover, the time to the next expected exacerbation can be derived directly from the outcome exacerbation frequency, which is the average number of exacerbations over a period of twelve months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures will be exacerbation frequency, duration and severity. Furthermore, health related quality of live, level of effective mucus clearance, level of motivation, peripheral muscle strength, functional exercise capacity, physical activity level and patients’ perceived benefit will be assessed. Also, co-morbidities, smoking and therapy compliance as well as health care contacts due to COPD will be recorded. | — |
Contacts
Public ContactE. Beekman
Department of Epidemiology Faculty of Health, Medicine and Life Sciences School for Public Health and Primary Care (CAPHRI) Peter Debyeplein 1, room A2.19 P.O. Box 616
Outcome results
None listed