Pre-habilitation in Lung Surgery Candidates

Study Overview
=================
Brief Summary
-----------------
We hypothesize that high intensity respiratory muscle training will improve ventilatory efficiency (VE/VCO2 slope) and will be associated with decreased PPC, decreased mortality and better quality of life in lung resection candidates. Accordingly, the aim of this study will be to compare rest and exercise ventilation and gas exchange parameters as well as postoperative complications, quality of life and mortality in patients who undergo high intensity respiratory muscle training compared to patients who receive the usual standard of care.

Detailed Description
-----------------
Lung resection surgery is the major curative option for lung cancer. Therefore, it is alarming that up to 37% of suitable patients are considered inoperable because of lung function impairment and those suitable for operation still carry a significant risk of especially postoperative pulmonary complications (PPC) development and increased mortality. Several predictors of postoperative morbidity and mortality have been identified. However, most of the factors are not easily modifiable before surgery. Ventilatory efficiency for carbon dioxide (VE/VCO2 slope) is an exercise parameter that has been shown to predict respiratory complications and mortality of lung resection candidates and to be superior to peak oxygen uptake (peak VO2). Importantly, in contrast to most previously established PPC risk factors, VE/VCO2 slope and peak VO2 may be therapeutically improved by physical and/or respiratory muscle training (e.g. by prehabilitation) and may thereby enable preoperative patient optimization. In thoracic surgery patients, trials looking at improvement of exercise capacity and PPC development give conflicting results, probably because of huge heterogeneity in terms of type, intensity and the length of pre-habilitation program. However, it seems that inclusion of only selected patients that may benefit from pre-habilitation (high risk patients), using VE/VCO2 slope and not peak VO2 to define the high risk patients and using interventions that could effectively improve VE/VCO2 slope (like the inspiratory and expiratory muscle training) is crucial and may be the key to lowering of postoperative pulmonary complications. Therefore, we hypothesize that high intensity respiratory muscle training will improve ventilatory efficiency (VE/VCO2 slope) and will be associated with decreased PPC, decreased mortality and better quality of life in lung resection candidates.

Official Title
-----------------
High Intensity Respiratory Muscle Training as a Pre-habilitation in Lung Surgery

Conditions
-----------------
Lung Cancer, Post-Op Complication

Intervention / Treatment
-----------------
* Other: High intensity inspiratory and expiratory muscle training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ventilatory efficiency (VE/VCO2) ≥ 33 Exclusion Criteria: contraindication for lung resection (e.g. inoperable tumor)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients will be randomized to control and intervention (pre-habilitation) group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No intervention will be done in this group. | |
| Experimental: Pre-Habilitation<br>Two weeks of high intensity respiratory muscle training, optional smoking cessation and psychological support. | Other: High intensity inspiratory and expiratory muscle training<br>* Inspiratory Muscle Training will be performed using the Threshold inspiratory muscle trainer device (Threshold IMT®, Philips Respironics, Inc., Murrysville, PA, USA). Expiratory muscle training (EMT) will be performed using the Threshold positive expiratory pressure device (Threshold PEP®, Philips Respironics, Inc., Murrysville, PA, USA) or Expiratory Muscle Strength Trainer EMST 150TM (Aspire Products), depending on the initial MEP. Patients will train 2 times a day, 7 days per week, for 2 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pulmonary complications | Post-operative pulmonary complications | from the first 30 post-operative days or from the hospital stay | 
| Post-operative cardiovascular complications | Post-operative cardiovascular complications | from the first 30 post-operative days or from the hospital stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | duration of hospital length of stay | from the first 30 post-operative days or from the hospital stay | 
| Intensive care unit length of stay | duration of intensive care unit length of stay | from the first 30 post-operative days or from the hospital stay | 
| Chest drainage | Duration of chest drainage | from the first 30 post-operative days or from the hospital stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiopulmonary exercise testing, VE/VCO2, PETCO2