Pre-habilitation in Lung Surgery Candidates
Primary Purpose
Lung Cancer, Post-Op Complication
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
High intensity inspiratory and expiratory muscle training
Sponsored by
About this trial
This is an interventional prevention trial for Lung Cancer focused on measuring cardiopulmonary exercise testing, VE/VCO2, PETCO2
Eligibility Criteria
Inclusion Criteria:
- ventilatory efficiency (VE/VCO2) ≥ 33
Exclusion Criteria:
- contraindication for lung resection (e.g. inoperable tumor)
Sites / Locations
- University Hospital BrnoRecruiting
- St. Anne's University Hospital
- Palacky University Olomouc
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Pre-Habilitation
Arm Description
No intervention will be done in this group.
Two weeks of high intensity respiratory muscle training, optional smoking cessation and psychological support.
Outcomes
Primary Outcome Measures
Post-operative pulmonary complications
Post-operative pulmonary complications
Post-operative cardiovascular complications
Post-operative cardiovascular complications
Secondary Outcome Measures
Hospital length of stay
duration of hospital length of stay
Intensive care unit length of stay
duration of intensive care unit length of stay
Chest drainage
Duration of chest drainage
Full Information
NCT ID
NCT04826575
First Posted
March 29, 2021
Last Updated
May 6, 2023
Sponsor
St. Anne's University Hospital Brno, Czech Republic
Collaborators
Brno University Hospital, Palacky University
1. Study Identification
Unique Protocol Identification Number
NCT04826575
Brief Title
Pre-habilitation in Lung Surgery Candidates
Official Title
High Intensity Respiratory Muscle Training as a Pre-habilitation in Lung Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Anne's University Hospital Brno, Czech Republic
Collaborators
Brno University Hospital, Palacky University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Post-Op Complication
Keywords
cardiopulmonary exercise testing, VE/VCO2, PETCO2
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eligible patients will be randomized to control and intervention (pre-habilitation) group
Masking
Care ProviderInvestigator
Masking Description
Caretaking provider and investigators gathering data will be blinded.
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention will be done in this group.
Arm Title
Pre-Habilitation
Arm Type
Experimental
Arm Description
Two weeks of high intensity respiratory muscle training, optional smoking cessation and psychological support.
Intervention Type
Other
Intervention Name(s)
High intensity inspiratory and expiratory muscle training
Intervention Description
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 Outcome Measure Information:
Title
Post-operative pulmonary complications
Description
Post-operative pulmonary complications
Time Frame
from the first 30 post-operative days or from the hospital stay
Title
Post-operative cardiovascular complications
Description
Post-operative cardiovascular complications
Time Frame
from the first 30 post-operative days or from the hospital stay
Secondary Outcome Measure Information:
Title
Hospital length of stay
Description
duration of hospital length of stay
Time Frame
from the first 30 post-operative days or from the hospital stay
Title
Intensive care unit length of stay
Description
duration of intensive care unit length of stay
Time Frame
from the first 30 post-operative days or from the hospital stay
Title
Chest drainage
Description
Duration of chest drainage
Time Frame
from the first 30 post-operative days or from the hospital stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ventilatory efficiency (VE/VCO2) ≥ 33
Exclusion Criteria:
contraindication for lung resection (e.g. inoperable tumor)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan Cundrle, M.D., Ph.D.
Phone
00420543182553
Email
Ivan.Cundrle@seznam.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Milos Chobola, M.D.
Phone
00420543182553
Email
milos.chobola@fnusa.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Cundrle, M.D., Ph.D.
Organizational Affiliation
St. Anne's University Hospital in Brno
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Brno
City
Brno
State/Province
Czech Republic
ZIP/Postal Code
62500
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristian Brat, M.D., Ph.D.
Phone
00420532232193
Email
Brat.Kristian@fnbrno.cz
First Name & Middle Initial & Last Name & Degree
Ladislav Mitas, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Marek Plutinsky, M.D.
First Name & Middle Initial & Last Name & Degree
Filip Dosbaba, Ph.D.
First Name & Middle Initial & Last Name & Degree
Martin Hartman
First Name & Middle Initial & Last Name & Degree
Anna Kapustová, M.D.
Facility Name
St. Anne's University Hospital
City
Brno
State/Province
Czech Republic
ZIP/Postal Code
656 91
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Cundrle, M.D., Ph.D.
Phone
00420543182553
Email
Ivan.Cundrle@seznam.cz
First Name & Middle Initial & Last Name & Degree
Milos Chobola, M.D.
Phone
00420543182553
Email
milos.chobola@fnusa.cz
First Name & Middle Initial & Last Name & Degree
Andrej Mazur, M.D.
First Name & Middle Initial & Last Name & Degree
Vladimir Sramek, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Pavel Homolka, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Zdenek Chovanec, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Alena Sedlakova
Facility Name
Palacky University Olomouc
City
Olomouc
ZIP/Postal Code
77147
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milan Sova, M.D., Ph.D.
Phone
420588444648
Email
milan.sova@upol.cz
First Name & Middle Initial & Last Name & Degree
Petr Jakubec, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Samuel Genzor, M.D.
First Name & Middle Initial & Last Name & Degree
Marek Szkorupa, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Eliska Sovova, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Marketa Sovova, M.D.
First Name & Middle Initial & Last Name & Degree
Barbora Imrichová
First Name & Middle Initial & Last Name & Degree
Monika Mikulaskova
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30345096
Citation
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.
Results Reference
background
PubMed Identifier
16640807
Citation
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.
Results Reference
background
PubMed Identifier
20805178
Citation
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.
Results Reference
background
PubMed Identifier
20609776
Citation
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.
Results Reference
background
PubMed Identifier
24626266
Citation
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.
Results Reference
background
PubMed Identifier
22560968
Citation
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.
Results Reference
background
PubMed Identifier
20356758
Citation
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.
Results Reference
background
PubMed Identifier
22197120
Citation
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.
Results Reference
background
PubMed Identifier
28870770
Citation
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.
Results Reference
background
PubMed Identifier
26528451
Citation
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.
Results Reference
background
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Pre-habilitation in Lung Surgery Candidates
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