Pre-habilitation in Lung Surgery Candidates

May 6, 2023 updated by: Ivan Cundrle, St. Anne's University Hospital Brno, Czech Republic

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Olomouc, Czechia, 77147
        • Not yet recruiting
        • Palacky University Olomouc
        • Contact:
        • Sub-Investigator:
          • Petr Jakubec, M.D., Ph.D.
        • Sub-Investigator:
          • Samuel Genzor, M.D.
        • Sub-Investigator:
          • Marek Szkorupa, M.D., Ph.D.
        • Sub-Investigator:
          • Eliska Sovova, M.D., Ph.D.
        • Sub-Investigator:
          • Marketa Sovova, M.D.
        • Sub-Investigator:
          • Barbora Imrichová
        • Sub-Investigator:
          • Monika Mikulaskova
    • Czech Republic
      • Brno, Czech Republic, Czechia, 62500
        • Recruiting
        • University Hospital Brno
        • Contact:
        • Sub-Investigator:
          • Ladislav Mitas, M.D., Ph.D.
        • Sub-Investigator:
          • Marek Plutinsky, M.D.
        • Sub-Investigator:
          • Filip Dosbaba, Ph.D.
        • Sub-Investigator:
          • Martin Hartman
        • Sub-Investigator:
          • Anna Kapustová, M.D.
      • Brno, Czech Republic, Czechia, 656 91
        • Not yet recruiting
        • St. Anne's University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Andrej Mazur, M.D.
        • Sub-Investigator:
          • Vladimir Sramek, M.D., Ph.D.
        • Sub-Investigator:
          • Pavel Homolka, M.D., Ph.D.
        • Sub-Investigator:
          • Zdenek Chovanec, M.D., Ph.D.
        • Sub-Investigator:
          • Alena Sedlakova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ventilatory efficiency (VE/VCO2) ≥ 33

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention will be done in this group.
Experimental: Pre-Habilitation
Two weeks of high intensity respiratory muscle training, optional smoking cessation and psychological support.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pulmonary complications
Time Frame: from the first 30 post-operative days or from the hospital stay
Post-operative pulmonary complications
from the first 30 post-operative days or from the hospital stay
Post-operative cardiovascular complications
Time Frame: from the first 30 post-operative days or from the hospital stay
Post-operative cardiovascular complications
from the first 30 post-operative days or from the hospital stay

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: from the first 30 post-operative days or from the hospital stay
duration of hospital length of stay
from the first 30 post-operative days or from the hospital stay
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
from the first 30 post-operative days or from the hospital stay
Chest drainage
Time Frame: from the first 30 post-operative days or from the hospital stay
Duration of chest drainage
from the first 30 post-operative days or from the hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Anne's University Hospital Brno, Czech Republic

Collaborators

Brno University Hospital
Palacky University

Investigators

  • Principal Investigator: Ivan Cundrle, M.D., Ph.D., St. Anne's University Hospital in Brno

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2021

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 6, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU21-06-00086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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