Reducing sudden worsening of the patient's condition in patients with progressive lung disease, with physiotherapy.

Conditions: chronic obstructive pulmonary diseaseCOPDexacerbationsphysiotherapyphysical therapycounselingRCTcohortprognostic profileschronisch obstructieve longziektenexacerbatiesfysiotherapieprognostische profielen

Registration Number: NL-OMON28024

Lead Sponsor: Prof. dr. RA de BieUniversiteit Maastricht

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 200

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;

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;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.