A Prospective Single Centre Open Randomized Trial on the Effect of Post-thoracotomy Pulmonary Rehabilitation on Quality of Life
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Isala
- Enrollment
- 57
- Locations
- 2
- Primary Endpoint
- SGRQ total score
Study Overview
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), 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.
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), 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •elective, thoracotomy patients with a surgical intention to cure.
- •age between 18 and 80 years.
- •ECOG 0 - 2 post-thoracotomy.
Exclusion Criteria
- •patients with chronic pain.
- •a previous thoracotomy.
- •comorbidity limiting rehabilitation.
- •non-compliance
Outcomes
Primary Outcomes
SGRQ total score
Time Frame: 12 months
Secondary Outcomes
- SF-36 scores(12 months)
- McGill pain questionnaire scores(12 months)
- Pulmonary function and 6MWD(3 months)
Investigators
Jan W.K. van den Berg
Dr.
Isala