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

2. srpna 2021 aktualizováno: ADIR Association

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Aktuální)

34

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Phase II time constant of Oxygen uptake kinetics (VO2τ), during a constant load test on a cyclo ergometer
Časové okno: 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)
before the preoperative training program
Phase II time constant of Oxygen uptake kinetics (VO2τ), during a constant load test on a cyclo ergometer
Časové okno: 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)
through preoperative training program completion (15 sessions), an average of 1 month

Sekundární výstupní opatření

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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

ADIR Association

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

16. července 2019

Primární dokončení (Aktuální)

19. května 2021

Dokončení studie (Aktuální)

16. června 2021

Termíny zápisu do studia

První předloženo

28. července 2019

První předloženo, které splnilo kritéria kontroly kvality

30. července 2019

První zveřejněno (Aktuální)

1. srpna 2019

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. srpna 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. srpna 2021

Naposledy ověřeno

1. srpna 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • Preo-Kinetics

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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