Reducing exacerbations in patients with chronic obstructive pulmonary disease with physiotherapy

Chronic obstructive pulmonary disease (COPD) is a major public health problem,
and is difficult to manage. The disease is highly prevalent and one of the main
causes of morbidity and mortality worldwide. Especially exacerbations of COPD
represent a large burden from both a patient- and healthcare perspective, since
these events often result in decreased physical health, impaired quality of
life and hospitalisation of patients.
Comprehensive rehabilitation programs, like guideline driven physiotherapy,
have shown to be effective in enhancing exercise capacity, reversing skeletal
muscle dysfunction and improving quality of life in COPD patients. However,
more information is needed to evaluate the efficacy of physiotherapy treatment
on COPD exacerbations. The focus on prevention of exacerbations by means of
physiotherapy treatment fits one of the prime management goals for COPD, which
is *reducing the frequency of hospitalisations due to exacerbations*. The
hypothesis in this study is: physiotherapy treatment is effective and
cost-effective in patients who recently experienced a COPD exacerbation by
reducing the frequency, duration and severity of following exacerbations. In
addition, it will improve the functional health status and quality of life of
COPD patients.

This study aims to investigate the potential of guideline driven physiotherapy
treatment as a supportive measure to postpone or prevent acute exacerbations in
COPD patients. So, the primary research question is: *What is the efficacy of
adding physiotherapy treatment to usual care on exacerbation frequency,
duration and severity in COPD patients who have recently experienced a COPD
exacerbation?*. Secondary research questions are: *What is the effect of
physiotherapy treatment on health status and quality of life in COPD patients
who have recently experienced an exacerbation?* and *What is the
cost-effectiveness of adding physiotherapy treatment to usual care on
exacerbations and hospitalisation of COPD patients who have recently
experienced a COPD exacerbation?*.

A cohort-nested, prospective, randomised, controlled trial with a 2-year
follow-up will be started to assess the efficacy and cost-effectiveness of
physiotherapy treatment in patients who recently experienced a COPD
exacerbation.

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 receive care as usual as provided
by their general practitioner and / or pulmonologist, controlled by their
physiotherapist, combined with evidence based physiotherapy (KNGF guideline
COPD, 2008). The usual care will be delivered according to standard of the
Dutch college of general practitioners (NHG standard, 2007). Participants from
the control group receive care as usual as provided by their general
practitioner and / or pulmonologist, but also controlled by their
physiotherapist (according to NHG standard, 2007). Besides, the patients from
the control group receive very low-intensity training that can be seen as
sham-treatment. Both groups will be monitored by a specific COPD electronic
documentation system and physiotherapists will also use this system as guidance
for treatment of the experimental group.

Independently of the randomised group, patients will visit a COPD certified
physiotherapist five times in a two-year period for counseling and physical
examination/questionnaires. These visits for measurements are part of standard
procedure. Patients from the experimental group will visit their
physiotherapist for COPD related high intensity physiotherapy treatment two
times every week, for one year. Besides, they are asked to do physical activity
on their own for one-three times a week for one year. Patients from the control
group are only asked to do physical activity on their own for three-five times
a week for one year, with the opportunity to train in the physiotherapy
practice for 30 minutes once a week. All visits for treatment and all advises
for home training are part of standard procedure, following the latest KNGF
guideline physiotherapy in COPD patients (2008) and the Dutch norm of healthy
activity (NNGB).
The study can only be done using patients suffering from a recent exacerbation.
By the information, COPD certified physiotherapists derive from frequent
physical examination and in most cases spirometry and a maximal bicycle test,
risks to participate in the study are very small and equivalent to standard
COPD related physiotherapeutic care and even smaller than risks associated with
patients who exercise on their own without physiotherapeutic control moments
(usual care). By participating in the study, patients may experience a
self-regulative and active way of reducing COPD related complaints, besides
standard medication treatment. No adverse events of pulmonary rehabilitation
(including physiotherapy) were reported in former studies.