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

Sponsor

ADIR Association (Other)

Overall Status

Completed

CT.gov ID

NCT04041297

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Other: Preoperative Pulmonary Rehabilitation

Study Design

Study Type:

Observational

Actual Enrollment :

34 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 16, 2019

Actual Primary Completion Date :

May 19, 2021

Actual Study Completion Date :

Jun 16, 2021

Outcome Measures

Primary Outcome Measures

Phase II time constant of Oxygen uptake kinetics (VO2τ), during a constant load test on a cyclo ergometer [before the preoperative training program]
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)
Phase II time constant of Oxygen uptake kinetics (VO2τ), during a constant load test on a cyclo ergometer [through preoperative training program completion (15 sessions), an average of 1 month]
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)

Secondary Outcome Measures

Phase II time constant of heart rate kinetics (HRτ), during a constant load test on a cyclo ergometer [before the preoperative training program]
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)
Phase II time constant of heart rate kinetics (HRτ), during a constant load test on a cyclo ergometer [through preoperative training program completion (15 sessions), an average of 1 month]
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)
Steady state oxygen uptake (VO2ss), during a constant load test on a cyclo ergometer [before the preoperative training program]
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)
Steady state oxygen uptake (VO2ss), during a constant load test on a cyclo ergometer [through preoperative training program completion (15 sessions), an average of 1 month]
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)
Steady-state heart rate (HRss), during a constant load test on a cyclo ergometer [before the preoperative training program]
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)
Steady-state heart rate (HRss), during a constant load test on a cyclo ergometer [through preoperative training program completion (15 sessions), an average of 1 month]
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)
Peak oxygen uptake (VO2peak) obtained during the incremental cardiopulmonary exercise testing [before the preoperative training program]
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.
Peak oxygen uptake (VO2peak) obtained during the incremental cardiopulmonary exercise testing [through preoperative training program completion (15 sessions), an average of 1 month]
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.
Maximum heart rate (HRmax) reached during the incremental cardiopulmonary exercise testing [before the preoperative training program]
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.
Maximum heart rate (HRmax) reached during the incremental cardiopulmonary exercise testing [through preoperative training program completion (15 sessions), an average of 1 month]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.