The effect of post-thoracotomy pulmonary rehabilitation on quality of life.

Morbidity in the post operative phase of thoracotomies is characterised by
pain, dyspnea, shoulder dysfunction and a loss of exercise tolerance may occur.
There is literature about post-thoracotomy painsyndromes and postoperative
quality of life has been investigated. However, data on post-thoracotomy
rehabilitation and influence on morbidity and recovery are not available.

Primary:

To evaluate the effects of a rehabilitation program on health related quality
of life (SGRQ) in the 12 months postoperative period in patients with an
elective thoracotomy.

Secondary:

To evaluate the effects of a rehabilitation program on general quality of life
(SF-36), acute / chronic postthoracotomy pain, impairment (changes in pulmonary
function), disability (exercise capacity) and start to complete recovery (ECOG
score of 0 or 1) 12 months postoperatively in patients with an elective
thoracotomy.

Eighty-eight elective thoracotomy patients with an age between the 18 and 80
years will be recruited during two years. The follow up for each patient will
be one year. The exclusion criteria are chronic pain involvement, a previous
thoracotomy, comorbidity limiting rehabilitation, psychiatric illness and
non-compliance.

Patients will be asked for participation before thoracotomy by informed consent
and will be randomised post-thoracotomy, before discharge into a rehabilitation
or 'regular care' group. Regular care is the regular approach after discharge;
without a pulmonary rehabilitation program and with permission of regular
physical therapy or when indicated (not related to thoracotomy). Regular
sporting and exercises (no special training programs) will be tolerated.
Randomisation will take place for rehabilitation or regular care by a
minimisation program with special attendance to age (< 70 or >= 70 years),
gender, the result of the 6 minute walk test (< 100 m or >= 100 m), the FEV1
(FEV1< 40% or >= FEV1 40 %) and type of surgery (pneumectomy vs other). During
screening a spirometry and a 6 minute walk test will be performed. The first
questionnaires (VAS, McGill pain questionnaire) will be given to the patients
after enrolment and before thoracotomy. The SGRQ and the SF 36 will be given
before, during and after rehabilitation.

The post-thoracotomy pain management consists of the standard analgetic
treatment; a thoracic epidural catheter which will be slowly replaced by
paracetamol, opioids and NSAID's. The consumption of analgetics will also be
documented in the follow up. Supplementary oxygen and lung inhalation is given
when necessary. This will be scored too. Regular physical therapy will be
started directly after thoracotomy as soon as possible.

The rehabilitation program will be initiated within a month after discharge.
The degree of the rehabilitation program will be separately detected for each
patient by a cycle test (heart rate) within 3 weeks post-thoracotomy. Patients
in the pulmonary rehabilitation program will be guided by a multidisciplinary
team of pulmonologist, physical therapist and social worker during 12 weeks.
The program will last 3 x 2 hours weekly consisting of exercise training and
education.

All patients will be followed up after discharge at 1 month, 3 months, 6 months
and 12 months at the outpatient clinic of the pulmonology department and the
pain clinic of the anaesthesia department. Before discharge and at these
intervals (except for the SGRQ at 1 month), patients have to fill
questionnaires about quality of life and pain (SF 36, SGRQ; McGill pain
questionnaire and VAS). Exercise capacity by means of the 6 minutes walk test
and spirometry will be measured after the accomplishment of the rehabilitation
program at 3 months. Patients of the control group will also be asked during
this visits whether they have had regular physical therapy or whether they are
sporting to evaluate the exact effects of the rehabilitation program.

During follow up all the results between the experimental rehabilitation group
and the regular care group will be compared. In the interpretation of these
results start to complete recovery is defined as an ECOG score of 0 or 1.

An early pulmonary rehabilitation program during 12 weeks (3x2 hours) initiated
within a month after discharge from the hospital and will be guided by a
multidisciplinary team consisting of pulmonologist, social worker and physical
therapist.

Burden and risks associated with participation:

There are no adverse effects due to the rehabilitation program. Patients in the
*regular care* group will not be guided by the multidisciplinary rehabilitation
team.
The disadvantages are the following: Patients have to fill in quality of life
questionnaires (SGRQ and SF-36), have to fill in pain questionnaires, have to
evaluate a painscale at the pain clinic (VAS and McGill Pain questionnaire) and
have to perform the 6 minutes walk-test and spirometry tests. Finally, patients
have to visit the pulmonologist and the pain clinic more frequently.

The expected benefits are a faster recovery with a better exercise tolerance,
less pain and a better quality of life.