Reducing exacerbations in patients with chronic obstructive pulmonary disease with physiotherapy

Completed

Conditions: chronic obstructive pulmonary disease
persistent lung disease
10006436

Registration Number: NL-OMON39765

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

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: Known by their general practitioner with the diagnosis COPD in GOLD stage 2, 3 or 4 (supported by a post-bronchodilator FEV1/FVC ratio < 0.7 and a post-bronchodilator FEV1 < 60% of predictive value).
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

1: COPD patients in GOLD stage 1 and stage 2 (supported by a post-bronchodilator FEV1 > 60% 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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure will be time to exacerbation, calculated as the<br /><br>time between randomisation and the onset of the first subsequent exacerbation<br /><br>for the first occurrence, and as the time between two exacerbations for<br /><br>following events.<br /><br>Exacerbations will be identified by means of an event based approach (seeking<br /><br>medical attention) and symptom based approach (clear increase of respiratory<br /><br>symptoms). Given the definition of the primary outcome measure time to<br /><br>exacerbation, results of the trial will be reported as a risk ratio for an<br /><br>exacerbation in the physiotherapy group versus the usual care group. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures will be exacerbation frequency, duration and<br /><br>severity. Furthermore, health related quality of live, level of effective mucus<br /><br>clearance, level of motivation, peripheral muscle strength, functional exercise<br /><br>capacity, physical activity level and patients* perceived benefit will be<br /><br>assessed. Also, co-morbidities, smoking and therapy compliance as well as<br /><br>health care contacts due to COPD will be recorded.</p><br>