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

NCT04041297 | Completed

• 1 other identifier: Preo-Kinetics
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer; Preoperative training; Prehabilitation; oxygen-uptake kinetics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Phase II time constant of heart rate kinetics (HRτ), during a constant load test on a cyclo ergometer

  before the preoperative training program

• 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

• Steady state oxygen uptake (VO2ss), during a constant load test on a cyclo ergometer

  before the preoperative training program

• 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

• Steady-state heart rate (HRss), during a constant load test on a cyclo ergometer

  before the preoperative training program

Interventions

Preoperative Pulmonary Rehabilitation OTHER

Each prehabilitation session will last approximately 90 minutes and will include: Endurance training at the ventilatory threshold, determined according to the initial CPET. The first session will last for 15 to 20 minutes then increase by 5 minutes each session to reach 45 minutes in total (including a 5-minute warm-up and 5 minutes of active recovery). The intensity will then increase by 5 or 10 W, as could be tolerated; Peripheral muscle strengthening at 60% to 70% of the 1-repetition maximum of 3 main components (quadriceps press, whole-leg extension, and upper limb pull down). Three sets of 12 movements will carry out for each exercise and the load will increase weekly as tolerated; Inspiratory muscle training using a threshold calibrated to at least 30% of the MIP. Patients will be encouraged to carry out 15 minutes of independent training daily and to increase the resistance regularly. Education to bronchial drainage techniques as well as directed coughing.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ADIR Association: lead

Study Sites (1)

ADIR Association

Bois-Guillaume, Normandy, 76230, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2019
• First Posted: August 1, 2019
• Study Start: July 16, 2019
• Primary Completion: May 19, 2021
• Study Completion: June 16, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Locations

FR (1)