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Reducing exacerbations in patients with chronic obstructive pulmonary disease with physiotherapy

Reducing exacerbations in patients with chronic obstructive pulmonary disease with physiotherapy - Reducing exacerbations in patients with COPD with physiotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39765
Enrollment
200
Registered
2009-09-17
Start date
2010-03-19
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic obstructive pulmonary disease persistent lung disease

Interventions

Physiotherapy according to the latest KNGF guideline physiotherapy in COPD patients (2008) will be compared to sham-treatment reflecting usual care. Participants from the experimental group will rec

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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: Known by their general practitioner with the diagnosis COPD in GOLD stage 2, 3 or 4 (supported by a post-bronchodilator FEV1/FVC ratio

Exclusion criteria

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).

Design outcomes

Primary

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

Secondary

MeasureTime 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)