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Pre-habilitation in Lung Surgery Candidates

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04826575
Enrollment
150
Registered
2021-04-01
Start date
2021-03-25
Completion date
2024-12-31
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Post-Op Complication

Keywords

cardiopulmonary exercise testing, VE/VCO2, PETCO2

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.

Interventions

OTHERHigh intensity inspiratory and expiratory muscle training

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.

Sponsors

Brno University Hospital
CollaboratorOTHER
Palacky University
CollaboratorOTHER
St. Anne's University Hospital Brno, Czech Republic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)

Masking description

Caretaking provider and investigators gathering data will be blinded.

Intervention model description

Eligible patients will be randomized to control and intervention (pre-habilitation) group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ventilatory efficiency (VE/VCO2) ≥ 33

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Post-operative pulmonary complicationsfrom the first 30 post-operative days or from the hospital stayPost-operative pulmonary complications
Post-operative cardiovascular complicationsfrom the first 30 post-operative days or from the hospital stayPost-operative cardiovascular complications

Secondary

MeasureTime frameDescription
Hospital length of stayfrom the first 30 post-operative days or from the hospital stayduration of hospital length of stay
Intensive care unit length of stayfrom the first 30 post-operative days or from the hospital stayduration of intensive care unit length of stay
Chest drainagefrom the first 30 post-operative days or from the hospital stayDuration of chest drainage

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026