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.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Normandie
-
Bois-Guillaume、Normandie、フランス、76230
- ADIR Association
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase II time constant of Oxygen uptake kinetics (VO2τ), during a constant load test on a cyclo ergometer
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase II time constant of heart rate kinetics (HRτ), during a constant load test on a cyclo ergometer
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
非小細胞肺がんの臨床試験
-
Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ
Preoperative Pulmonary Rehabilitationの臨床試験
-
Bahçeşehir UniversityNevsehir Haci Bektas Veli Universityまだ募集していません