Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460668
Status:
COMPLETED
Last Update Posted:
2013-04-08
First Post:
2007-04-13
Brief Title:
The Effect of Post-thoracotomy Pulmonary Rehabilitation on Quality of Life
Sponsor:
Isala
Organization:
Isala
Study Overview
Official Title:
A Prospective Single Centre Open Randomized Trial on the Effect of Post-thoracotomy Pulmonary Rehabilitation on Quality of Life
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is 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 and to evaluate the effects of the program on general quality of life SF-36 acutechronic 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
Detailed Description:
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 acutechronic 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 NSAIDs 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
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 acutechronic 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 NSAIDs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None