Pre-habilitation in Lung Surgery Candidates

Not Applicable

Completed

• Conditions: Lung Cancer; Post-Op Complication
• Interventions: Other: High intensity inspiratory and expiratory muscle training

• Registration Number: NCT04826575
• Lead Sponsor: St. Anne's University Hospital Brno, Czech Republic

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.

Study Timeline

• Study Start: 2021-03-25
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• ventilatory efficiency (VE/VCO2) ≥ 33

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-Habilitation	High intensity inspiratory and expiratory muscle training	Two weeks of high intensity respiratory muscle training, optional smoking cessation and psychological support.

Primary Outcome Measures

Name	Time	Method
Post-operative cardiovascular complications	from the first 30 post-operative days or from the hospital stay	Post-operative cardiovascular complications
Post-operative pulmonary complications	from the first 30 post-operative days or from the hospital stay	Post-operative pulmonary complications

Secondary Outcome Measures

Name	Time	Method
Chest drainage	from the first 30 post-operative days or from the hospital stay	Duration of chest drainage
Intensive care unit length of stay	from the first 30 post-operative days or from the hospital stay	duration of intensive care unit length of stay
Hospital length of stay	from the first 30 post-operative days or from the hospital stay	duration of hospital length of stay

Trial Locations

Locations (3)

University Hospital Brno; 🇨🇿 Brno, Czech Republic, Czechia

St. Anne's University Hospital; 🇨🇿 Brno, Czech Republic, Czechia

Palacky University Olomouc; 🇨🇿 Olomouc, Czechia