Trial Information

A Prospective Single Centre Open Randomized Trial on 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.

Aim of the study:

Primary: To evaluate the effects of an integrated multidisciplinary rehabilitation program
on health related quality of life in the 12 months postoperative period in patients with an
elective thoracotomy.

Secondary: To evaluate the effects of the program on general quality of life (SF-36),
acute/chronic post-thoracotomy 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.

Study design: prospective single-centre, open randomised trial. 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.
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 FEV (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 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 (SF-36 and SGRQ) and pain
(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.

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 ECOG 0 and 1.

Randomisation, blinding and treatment allocation 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).

Study population:

Eighty-eight patients with an elective thoracotomy between the age of 18 and 80 years.

Intervention:

An early pulmonary rehabilitation program during 12 weeks initiated after discharge from the
hospital.

Inclusion criteria:

1. elective, thoracotomy patients with a surgical intention to cure.

2. age between 18 and 80 years.

3. ECOG 0 - 2 post-thoracotomy.

Exclusion criteria:

1. patients with chronic pain.

2. a previous thoracotomy.

3. comorbidity limiting rehabilitation.

4. non-compliance.

Main study endpoints

1. health related quality of life (SGRQ score). Secondary study endpoints

1. general quality of life (SF-36).

2. acute / chronic post-thoracotomy pain (McGill and VAS).

3. impairment (changes in pulmonary function).

4. disability (exercise capacity; 6 Minute Walking Distance).

5. start to complete recovery (ECOG score of 0 or 1).

Statistical analysis: All analysis will be on an intention-to-treat basis. The primary
analysis will be on an intention-to-treat basis. The mean change in the primary endpoint
(SGRQ total score) after 6 months between the groups will be analysed using unpaired
t-tests. These tests will also be used to analyse differences after 12 months in secondary
endpoints (SF-36 scores, 6-minute walking difference, pain scores, and lung function
values). Since some study endpoints (quality of life and pain scores) will be measured more
than two times (repeatedly measured) the course of these scores in time will be tested using
MANOVA-analysis. To test for differences in proportions (proportion of patients with an
ECOG-score of 0 or 1 after rehabilitation) the Chi2 -test will be used.

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,
pain questionnaires and have to evaluate painscales (SGRQ, SF-36; McGill Pain questionnaire
and VAS) have to perform the 6 minutes walk-test and a spirometry twice. Finally, patients
have to visit the pulmonologist and the pain clinic more frequently. The expected benefits
are a better exercise tolerance, less pain and a better quality of life; a faster recovery.