Clinical trial NCT04826575: Pre-habilitation in Lung Surgery Candidates
Official title: High Intensity Respiratory Muscle Training as a Pre-habilitation in Lung Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Post-Op Complication
Keywords: cardiopulmonary exercise testing
VE/VCO2
PETCO2
Lead sponsor: St. Anne's University Hospital Brno, Czech Republic
Sponsor class: OTHER
Collaborators: name: Brno University Hospital
name: Palacky University
First posted: 2021-04-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomized to control and intervention (pre-habilitation) group
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* ventilatory efficiency (VE/VCO2) ≥ 33

Exclusion Criteria:

* contraindication for lung resection (e.g. inoperable tumor)

Primary outcomes:
measure: Post-operative pulmonary complications
timeFrame: from the first 30 post-operative days or from the hospital stay
measure: Post-operative cardiovascular complications
timeFrame: from the first 30 post-operative days or from the hospital stay
Secondary outcomes:
measure: Hospital length of stay
timeFrame: from the first 30 post-operative days or from the hospital stay
measure: Intensive care unit length of stay
timeFrame: from the first 30 post-operative days or from the hospital stay
measure: Chest drainage
timeFrame: from the first 30 post-operative days or from the hospital stay
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
state: Czech Republic
city: Brno
country: Czechia
facility: St. Anne's University Hospital
state: Czech Republic
city: Olomouc
country: Czechia
facility: Palacky University Olomouc
Study officials:
affiliation: St. Anne's University Hospital in Brno
name: Ivan Cundrle, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
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