Evaluation of NSCLC Patients' Oxygen Uptake On-kinetics at Cycle-ergometer During Prehabilitation (Preo-Kinetics)

Evaluation of Non-Small Cell Lung Cancer Patients' Oxygen Uptake On-kinetics at Cycle-ergometer During Prehabilitation

In developed countries cancer has become the second leading cause of death after cardiovascular disease. The lung is a particularly exposed organ since broncho-pulmonary cancers rank second in terms of incidence, and the first rank in terms of mortality of all cancers listed in like reported in United States.

Lung resection surgery is currently the recommended curative treatment for the early stages of non-small cell lung cancer (NSCLC). Despite this preferred indication, some patients can not be eligible for surgery because of their cardiovascular or respiratory comorbidities or their impaired functional capacity.

Thus, the evaluation of aerobic capacity through cardiopulmonary exercise testing (CPET) of patients estimated at risk of postoperative complication is now recommended to estimate the level of predictive risk associated. The American Thoracic Society and the European Respiratory Socitety agree on thresholds of <10 and> 20 ml/kg/min of maximum oxygen uptake (VO2peak) respectively determining a high or low postoperative risk, between these two thresholds risk is considered moderate.

Aerobic capacity is traditionally expressed in terms of maximum oxygen uptake (VO2max or VO2peak) evaluated during an incremental CPET. In patients with significant respiratory impairment, these tests are often limited by ventilation and sub-maximally on the metabolic or cardiac parameters. However, the analysis of the VO2 kinetic during a constant-intensity test of moderate intensity is also a relevant way of measuring aerobic conditioning. Indeed, the time constant (τ) of phase II of VO2 kinetics (VO2τ) is a marker that closely reflects the adjustment of oxidative metabolism in skeletal muscle. Analysis of the kinetic parameters of the cardio-respiratory response to exercise has been shown to be reproducible and training-sensitive in patients with chronic obstructive pulmonary disease (COPD). The value of VO2τ was also reported to be strongly correlated with markers of severity and prognosis in COPD patients. Previous work has shown that exercise training can improve the speed of the VO2 kinetic response in COPD patients as well as in healthy subjects.

To date, no study to our knowledge has evaluated the kinetics of the cardiorespiratory response during moderate intensity constant-load test in patients with NSCLC. In this context, this work aims to evaluate the applicability of this measure as well as its evolution during a preoperative exercise training program in patients with NSCLC.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Other: Preoperative Pulmonary Rehabilitation

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• France
  • Normandie
    • Bois-Guillaume, Normandie, France, 76230
      • ADIR Association

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients referred in the ADIR Association for a preoperative pulmonary rehabilitation program in preparation for lung resection surgery for non-small cell lung cancer are concerned.

They are contacted by one of the rehabilitation physiotherapists to carry out an inclusion consultation in the respiratory rehabilitation program. During this session, the study is presented to them and their consent to study is collected.

Participation in or refusal of the study does not affect the overall standard of care provided during the program.

Description

Inclusion Criteria:

• Age> 18 years old;
• Beneficiary of a social security scheme;
• Non-Small Cell Lung Cancer or suspicion of bronchial neoplasia;
• Addressed to respiratory rehabilitation in a preoperative setting with a moderate to high risk estimate (VO2peak < 20 ml/kg/min);
• Intervention date not established when included in the program or ≥ 5 wk.

Exclusion Criteria:

• Patient under guardianship;
• Pregnant or lactating woman;
• Cardiological contraindication to training;
• Neoadjuvant radio-chemotherapy;
• Refusal to carry out a training program in a rehabilitation center;
• Orthopedic, neurological, vascular or neuromuscular pathology limiting training;
• Exacerbation or deterioration of the general condition requiring stopping the preoperative re-training program;
• Modification of the therapeutic project at a multidisciplinary consultation meeting requiring the cessation of rehabilitation or participation in the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase II time constant of Oxygen uptake kinetics (VO2τ), during a constant load test on a cyclo ergometer	maintaining a constant power corresponding to 80% of the anaerobic threshold or failing that 50% of the VO2peak obtained at the incremental CPET (Puente-Maestu et al. 2001). VO2 uptake is collected cycle by cycle by a gas exchange analysis system (Vyntus® CPX, CareFusion, Hoechberg, Germany)	before the preoperative training program
Phase II time constant of Oxygen uptake kinetics (VO2τ), during a constant load test on a cyclo ergometer	maintaining a constant power corresponding to 80% of the anaerobic threshold or failing that 50% of the VO2peak obtained at the incremental CPET (Puente-Maestu et al. 2001). VO2 uptake is collected cycle by cycle by a gas exchange analysis system (Vyntus® CPX, CareFusion, Hoechberg, Germany)	through preoperative training program completion (15 sessions), an average of 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase II time constant of heart rate kinetics (HRτ), during a constant load test on a cyclo ergometer	maintaining a constant power corresponding to 80% of the anaerobic threshold or failing that 50% of the VO2peak obtained at the incremental CPET (Puente-Maestu et al. 2001). Heart rate is continuously collected by a 12-lead electrocardiogram dyspositif (EC Sense Lexor, Cardiolex, Solna, Sweden)	before the preoperative training program
Phase II time constant of heart rate kinetics (HRτ), during a constant load test on a cyclo ergometer	maintaining a constant power corresponding to 80% of the anaerobic threshold or failing that 50% of the VO2peak obtained at the incremental CPET (Puente-Maestu et al. 2001). Heart rate is continuously collected by a 12-lead electrocardiogram dyspositif (EC Sense Lexor, Cardiolex, Solna, Sweden)	through preoperative training program completion (15 sessions), an average of 1 month
Steady state oxygen uptake (VO2ss), during a constant load test on a cyclo ergometer	maintaining a constant power corresponding to 80% of the anaerobic threshold or failing that 50% of the VO2peak obtained at the incremental CPET (Puente-Maestu et al. 2001). VO2 uptake is collected cycle by cycle by a gas exchange analysis system (Vyntus® CPX, CareFusion, Hoechberg, Germany)	before the preoperative training program
Steady state oxygen uptake (VO2ss), during a constant load test on a cyclo ergometer	maintaining a constant power corresponding to 80% of the anaerobic threshold or failing that 50% of the VO2peak obtained at the incremental CPET (Puente-Maestu et al. 2001). VO2 uptake is collected cycle by cycle by a gas exchange analysis system (Vyntus® CPX, CareFusion, Hoechberg, Germany)	through preoperative training program completion (15 sessions), an average of 1 month
Steady-state heart rate (HRss), during a constant load test on a cyclo ergometer	maintaining a constant power corresponding to 80% of the anaerobic threshold or failing that 50% of the VO2peak obtained at the incremental CPET (Puente-Maestu et al. 2001). Heart rate is continuously collected by a 12-lead electrocardiogram dyspositif (EC Sense Lexor, Cardiolex, Solna, Sweden)	before the preoperative training program
Steady-state heart rate (HRss), during a constant load test on a cyclo ergometer	maintaining a constant power corresponding to 80% of the anaerobic threshold or failing that 50% of the VO2peak obtained at the incremental CPET (Puente-Maestu et al. 2001). Heart rate is continuously collected by a 12-lead electrocardiogram dyspositif (EC Sense Lexor, Cardiolex, Solna, Sweden)	through preoperative training program completion (15 sessions), an average of 1 month
Peak oxygen uptake (VO2peak) obtained during the incremental cardiopulmonary exercise testing	Incremental cardiopulmonary exercise testing (CPET) standardized on the statement of the American Thoracic Society and American College of Chest Physicians 2003, on cyclo-ergometer. Performed during the evaluation process before pulmonary resection surgery and allows to refer patients at risk to preoperative retraining.	before the preoperative training program
Peak oxygen uptake (VO2peak) obtained during the incremental cardiopulmonary exercise testing	Incremental cardiopulmonary exercise testing (CPET) standardized on the statement of the American Thoracic Society and American College of Chest Physicians 2003, on cyclo-ergometer. Evaluation post preoperative exercise training to re-calculate postoperative risk.	through preoperative training program completion (15 sessions), an average of 1 month
Maximum heart rate (HRmax) reached during the incremental cardiopulmonary exercise testing	Incremental cardiopulmonary exercise testing (CPET) standardized on the statement of the American Thoracic Society and American College of Chest Physicians 2003, on cyclo-ergometer. Evaluation post preoperative exercise training to re-calculate postoperative risk.	before the preoperative training program
Maximum heart rate (HRmax) reached during the incremental cardiopulmonary exercise testing	Incremental cardiopulmonary exercise testing (CPET) standardized on the statement of the American Thoracic Society and American College of Chest Physicians 2003, on cyclo-ergometer. Evaluation post preoperative exercise training to re-calculate postoperative risk.	through preoperative training program completion (15 sessions), an average of 1 month

Collaborators and Investigators

• Sponsor: ADIR Association

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2019
• Primary Completion (Actual): May 19, 2021
• Study Completion (Actual): June 16, 2021

Study Registration Dates

• First Submitted: July 28, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Non Small Cell Lung Cancer; Prehabilitation; Preoperative training; oxygen-uptake kinetics
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: Preo-Kinetics

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No