Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer

Study Overview
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Brief Summary
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Morbidity in the post-operative phase of pulmonary surgery is characterised by impairment due to pain, dyspnoea and loss of exercise tolerance. We demonstrated previously that rehabilitation after thoracotomy is limited due to pain. Since minimal invasive surgery is the new standard in lung cancer, resulting in a reduction of postoperative pain, we believe there are new possibilities for post-operative integrated multidisciplinary rehabilitation in lung cancer.

Official Title
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Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer

Conditions
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Surgery, Lung Cancer

Intervention / Treatment
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* Behavioral: Pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective, minimal invasive surgery with intention to cure. Age between 18 and 80 years. ECOG 0 - 2 post-surgery. Exclusion Criteria: Patients with chronic pain Previous pulmonary surgery Comorbidity limiting rehabilitation Rheumatoid arthritis Severe ischaemic heart disease or myocardial failure; EF ≤ 35 %. Muscle disease Fibromyalgia Neurologic disorders (Parkinson disease, CVA and lesions of the spinal cord) Psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>An integrated multidisciplinary rehabilitation program on general quality of life (short form 36, SF-36, subdomain general health) in the 12 months postoperative period in patients undergoing elective minimal invasive surgery in lung cancer | Behavioral: Pulmonary rehabilitation<br>* Patients in the intervention group will receive physical therapy, scheduled pain monitoring and coaching by a social worker. The intensity of the rehabilitation training program will be determined separately for each patient by a steepramp and 1-repetition test within 3 weeks post-operative. The intervention group will be trained and educated in 2 sessions of 2 hours per week, for a period of 3 months.<br>* Other names: Pain clinic;|
| No Intervention: Control<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (SF-36) | effects of an integrated multidisciplinary rehabilitation program on general quality of life | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SGRQ | health-related quality of life | 12 months | 
| VAS | post-operative pain | 12 months | 
| WHO-PS | performance score | 12 months | 
| 6 minute walking distance | exercise tolerance | 12 months | 
| international physical activity questionnaire, iPAQ | physical activity | 12 months |