Pre-habilitation in Lung Surgery Candidates

NCT04826575 | Completed

• 1 other identifier: NU21-06-00086
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer; Post-Op Complication

Keywords

cardiopulmonary exercise testing; VE/VCO2; PETCO2

Outcome Measures

Primary Outcomes (2)

• Post-operative pulmonary complications

  Post-operative pulmonary complications

  from the first 30 post-operative days or from the hospital stay

• Post-operative cardiovascular complications

  Post-operative cardiovascular complications

  from the first 30 post-operative days or from the hospital stay

Secondary Outcomes (3)

• Hospital length of stay

  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

• Chest drainage

  from the first 30 post-operative days or from the hospital stay

Study Arms (2)

Control

NO INTERVENTION

No intervention will be done in this group.

Pre-Habilitation

EXPERIMENTAL

Two weeks of high intensity respiratory muscle training, optional smoking cessation and psychological support.

Other: High intensity inspiratory and expiratory muscle training

Interventions

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.

Pre-Habilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ventilatory efficiency (VE/VCO2) ≥ 33

You may not qualify if:

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

Sponsors & Collaborators

• St. Anne's University Hospital Brno, Czech Republic: lead
• Brno University Hospital: collaborator
• Palacky University: collaborator

Study Sites (3)

University Hospital Brno

Brno, Czech Republic, 62500, Czechia

Location

St. Anne's University Hospital

Brno, Czech Republic, 656 91, Czechia

Location

Palacky University Olomouc

Olomouc, 77147, Czechia

Location

Related Publications (11)

• Sanchez-Lorente D, Navarro-Ripoll R, Guzman R, Moises J, Gimeno E, Boada M, Molins L. Prehabilitation in thoracic surgery. J Thorac Dis. 2018 Aug;10(Suppl 22):S2593-S2600. doi: 10.21037/jtd.2018.08.18.

  PMID: 30345096 BACKGROUND

• Baser S, Shannon VR, Eapen GA, Jimenez CA, Onn A, Keus L, Lin E, Morice RC. Pulmonary dysfunction as a major cause of inoperability among patients with non-small-cell lung cancer. Clin Lung Cancer. 2006 Mar;7(5):344-9. doi: 10.3816/CLC.2006.n.017.

  PMID: 16640807 BACKGROUND

• Agostini P, Cieslik H, Rathinam S, Bishay E, Kalkat MS, Rajesh PB, Steyn RS, Singh S, Naidu B. Postoperative pulmonary complications following thoracic surgery: are there any modifiable risk factors? Thorax. 2010 Sep;65(9):815-8. doi: 10.1136/thx.2009.123083.

  PMID: 20805178 BACKGROUND

• Brunelli A, Varela G, Refai M, Jimenez MF, Pompili C, Sabbatini A, Aranda JL. A scoring system to predict the risk of prolonged air leak after lobectomy. Ann Thorac Surg. 2010 Jul;90(1):204-9. doi: 10.1016/j.athoracsur.2010.02.054.

  PMID: 20609776 BACKGROUND

• Stanzani F, Paisani Dde M, Oliveira Ad, Souza RC, Perfeito JA, Faresin SM. Morbidity, mortality, and categorization of the risk of perioperative complications in lung cancer patients. J Bras Pneumol. 2014 Jan-Feb;40(1):21-9. doi: 10.1590/S1806-37132014000100004.

  PMID: 24626266 BACKGROUND

• Brunelli A, Belardinelli R, Pompili C, Xiume F, Refai M, Salati M, Sabbatini A. Minute ventilation-to-carbon dioxide output (VE/VCO2) slope is the strongest predictor of respiratory complications and death after pulmonary resection. Ann Thorac Surg. 2012 Jun;93(6):1802-6. doi: 10.1016/j.athoracsur.2012.03.022. Epub 2012 May 4.

  PMID: 22560968 BACKGROUND

• Torchio R, Guglielmo M, Giardino R, Ardissone F, Ciacco C, Gulotta C, Veljkovic A, Bugiani M. Exercise ventilatory inefficiency and mortality in patients with chronic obstructive pulmonary disease undergoing surgery for non-small-cell lung cancer. Eur J Cardiothorac Surg. 2010 Jul;38(1):14-9. doi: 10.1016/j.ejcts.2010.01.032. Epub 2010 Mar 30.

  PMID: 20356758 BACKGROUND

• Fu TC, Wang CH, Lin PS, Hsu CC, Cherng WJ, Huang SC, Liu MH, Chiang CL, Wang JS. Aerobic interval training improves oxygen uptake efficiency by enhancing cerebral and muscular hemodynamics in patients with heart failure. Int J Cardiol. 2013 Jul 15;167(1):41-50. doi: 10.1016/j.ijcard.2011.11.086. Epub 2011 Dec 22.

  PMID: 22197120 BACKGROUND

• Tucker WJ, Lijauco CC, Hearon CM Jr, Angadi SS, Nelson MD, Sarma S, Nanayakkara S, La Gerche A, Haykowsky MJ. Mechanisms of the Improvement in Peak VO2 With Exercise Training in Heart Failure With Reduced or Preserved Ejection Fraction. Heart Lung Circ. 2018 Jan;27(1):9-21. doi: 10.1016/j.hlc.2017.07.002. Epub 2017 Aug 4.

  PMID: 28870770 BACKGROUND

• Kasahara Y, Izawa KP, Watanabe S, Osada N, Omiya K. The Relation of Respiratory Muscle Strength to Disease Severity and Abnormal Ventilation During Exercise in Chronic Heart Failure Patients. Res Cardiovasc Med. 2015 Sep 15;4(4):e28944. doi: 10.5812/cardiovascmed.28944. eCollection 2015 Nov.

  PMID: 26528451 BACKGROUND

• Filakovszky A, Brat K, Tschoellitsch T, Bartos S, Mazur A, Meier J, Olson L, Cundrle I. Cardiopulmonary exercise testing before lung resection surgery: still indicated? Evaluating predictive utility using machine learning. Thorax. 2025 Oct 2:thorax-2024-221485. doi: 10.1136/thorax-2024-221485. Online ahead of print.

  PMID: 41043965 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ivan Cundrle, M.D., Ph.D.

  St. Anne's University Hospital in Brno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Caretaking provider and investigators gathering data will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ivan Cundrle M.D., Ph.D.

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

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: March 25, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3)