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Completed

NCT Number: NCT04826575

Pre-habilitation in Lung Surgery Candidates

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Op Complication Postoperative Complications Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ventilatory efficiency (VE/VCO2) ≥ 33

Exclusion criteria

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

Treatment and study plan

High intensity inspiratory and expiratory muscle training

Other

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.

Primary outcomes

  1. Post-operative pulmonary complications

    Time frame: from the first 30 post-operative days or from the hospital stay

    Post-operative pulmonary complications

  2. Post-operative cardiovascular complications

    Time frame: from the first 30 post-operative days or from the hospital stay

    Post-operative cardiovascular complications

Secondary outcomes

  1. Hospital length of stay

    Time frame: from the first 30 post-operative days or from the hospital stay

    duration of hospital length of stay

  2. Intensive care unit length of stay

    Time frame: from the first 30 post-operative days or from the hospital stay

    duration of intensive care unit length of stay

  3. Chest drainage

    Time frame: from the first 30 post-operative days or from the hospital stay

    Duration of chest drainage

Sponsors and collaborators

Lead sponsor

St. Anne's University Hospital Brno, Czech Republic

Other

Collaborators

  • Brno University Hospital
  • Palacky University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2021
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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