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Clinical Trials/NCT04826575
NCT04826575CompletedNot Applicable

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

St. Anne's University Hospital Brno, Czech Republic6 sites in 1 country150 target enrollmentStarted: March 25, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
150
Locations
6
Primary Endpoint
Post-operative pulmonary complications

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Care Provider, Investigator)

Masking Description

Caretaking provider and investigators gathering data will be blinded.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ventilatory efficiency (VE/VCO2) ≥ 33

Exclusion Criteria

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

Outcomes

Primary Outcomes

Post-operative pulmonary complications

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

Post-operative pulmonary complications

Post-operative cardiovascular complications

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

Post-operative cardiovascular complications

Secondary Outcomes

  • Chest drainage(from the first 30 post-operative days or from the hospital stay)
  • Intensive care unit length of stay(from the first 30 post-operative days or from the hospital stay)
  • Hospital length of stay(from the first 30 post-operative days or from the hospital stay)

Investigators

Sponsor
St. Anne's University Hospital Brno, Czech Republic
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ivan Cundrle

Ivan Cundrle M.D., Ph.D.

St. Anne's University Hospital Brno, Czech Republic

Study Sites (6)

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