Pre-habilitation in Lung Surgery Candidates

NCT ID: NCT04826575

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-25

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer Post-Op Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators
Caretaking provider and investigators gathering data will be blinded.

Study Groups

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Control

No intervention will be done in this group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Pre-Habilitation

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

Group Type EXPERIMENTAL

High intensity inspiratory and expiratory muscle training

Intervention Type 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.

Interventions

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High 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ventilatory efficiency (VE/VCO2) ≥ 33

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brno University Hospital

OTHER

Sponsor Role collaborator

Palacky University

OTHER

Sponsor Role collaborator

St. Anne's University Hospital Brno, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Ivan Cundrle

Ivan Cundrle M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ivan Cundrle, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

St. Anne's University Hospital in Brno

Locations

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University Hospital Brno

Brno, Czech Republic, Czechia

Site Status

St. Anne's University Hospital

Brno, Czech Republic, Czechia

Site Status

Palacky University Olomouc

Olomouc, , Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type BACKGROUND
PMID: 30345096 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16640807 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20805178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20609776 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24626266 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22560968 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20356758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22197120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28870770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26528451 (View on PubMed)

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.

Reference Type DERIVED
PMID: 41043965 (View on PubMed)

Other Identifiers

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NU21-06-00086

Identifier Type: -

Identifier Source: org_study_id

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