Effect of Two Different Preoperative Training Densities in Patients With Non-small-cell Lung Cancer Before Lung Resection Surgery (Preo-Dens)
Pulmonary resection surgery is currently the recommended curative treatment for early stages of non-small cell lung cancer. The implementation of preoperative respiratory rehabilitation programs has shown beneficial results on pulmonary function, functional level, cardiorespiratory conditioning and the occurrence and severity of postoperative complications in this population of patients. Despite these benefits, the most recent meta-analyzes highlight the fact that training modalities (duration, frequencies, intensity) are very heterogeneous. It is then difficult to structure a program only on the basis of data from the literature.
In a cohort analysis of 50 patients trained from 2014 to 2017, our team reported a significantly greater improvement in physiological parameters in patients who performed 15 or more preoperative training sessions. This number of 15 outpatient sessions is therefore considered a minimum training goal in our current practice.
The difficulty of the oncological context is to find the compromise between the necessary diligence to initiate the cancer surgical treatment and the necessary time to obtain the benefits of the preoperative rehabilitation. Previous study reports the difficulty of setting up a four-week training program, perceived as delaying surgery. In order to prevent any risk of prolonging the surgical management time, rehabilitation teams routinely offer short programs with high training frequencies of up to five to six sessions per week. It seems important to note that preoperative rehabilitation is normally considered in patients for whom there is a risk of moderate to high postoperative complications according to the European and North American recommendations. Thus these patients generally benefit from a longer period of assessment than patients whose risk is considered low in terms of their cardio-respiratory and muscular function.
The median duration between the physiological evaluation of patients considered "at risk" before pulmonary resection surgery is 44 (Q1-Q3 29-76) days at Rouen University Hospital, with no significant differences observed between patients who have benefited or not from preoperative rehabilitation. Some teams have even pointed out that there is no difference in survival prognosis in the short or long term between patients who have had an operative delay of more or less 60 or 90 days respectively, which shows the compatibility with the set up a dedicated training course.
As mentioned earlier, the concept of delay has led to extremely dense training for a functionally and cardio-respiratory fragile target population as evidenced by pejorative VO2peak. The density of the training, failing to generate significant physiological stimulation, may increase fatigue or limit adherence to training, especially if it requires movement, and is added to a therapeutic planning including many consultations and further examinations. To date, no study has evaluated the density of preoperative supervised training on pre-surgical benefits.
The objective of this work is to compare the effectiveness of a program of 15 training sessions on VO2peak according to two different densities, namely five times a week over three weeks, or three times a week over five weeks.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Normandie
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Bois-Guillaume、Normandie、フランス、76230
- ADIR Association
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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
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
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：Group 1
5 Preoperative Pulmonary Rehabilitation sessions / week during 3 weeks.
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Each prehabilitation session will last approximately 90 minutes and will include:
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他の：Group 2
3 Preoperative Pulmonary Rehabilitation sessions / week during 5 weeks.
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Each prehabilitation session will last approximately 90 minutes and will include:
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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 |
|---|---|---|
|
peak dioxyen consumption (VO2peak)
時間枠：before the preoperative training program
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VO2peak (in ml/kg/min) measured during and incremental Cardio-Pulmonary Exercise Testing (CPET)
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before the preoperative training program
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peak dioxyen consumption (VO2peak)
時間枠：through preoperative training program completion (15 sessions)
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VO2peak (in ml/kg/min) measured during and incremental Cardio-Pulmonary Exercise Testing (CPET)
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through preoperative training program completion (15 sessions)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
peak work-rate (WRpeak)
時間枠：before the preoperative training program
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maximum power reached during the Cardio-Pulmonary Exercise Testing (CPET)
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before the preoperative training program
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|
peak work-rate (WRpeak)
時間枠：through preoperative training program completion (15 sessions)
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maximum power reached during the Cardio-Pulmonary Exercise Testing (CPET)
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through preoperative training program completion (15 sessions)
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oxygen consumption at ventilatory threshold (VO2vt)
時間枠：before the preoperative training program
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oxygen consumption at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)
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before the preoperative training program
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oxygen consumption at ventilatory threshold (VO2vt)
時間枠：through preoperative training program completion (15 sessions)
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oxygen consumption at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)
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through preoperative training program completion (15 sessions)
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work-rate at ventilatory threshold (WRvt)
時間枠：before the preoperative training program
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work-rate at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)
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before the preoperative training program
|
|
work-rate at ventilatory threshold (WRvt)
時間枠：through preoperative training program completion (15 sessions)
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work-rate at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)
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through preoperative training program completion (15 sessions)
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ventilatory efficiency (VE/VCO2 slope)
時間枠：before the preoperative training program
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linear regression of the ratio between the increase in minute ventilation and the expired carbon dioxide flow (VE/VCO2 slope)
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before the preoperative training program
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ventilatory efficiency (VE/VCO2 slope)
時間枠：through preoperative training program completion (15 sessions)
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linear regression of the ratio between the increase in minute ventilation and the expired carbon dioxide flow (VE/VCO2 slope)
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through preoperative training program completion (15 sessions)
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body mass index (BMI)
時間枠：before the preoperative training program
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weight in kilograms divided by the square of height in meters
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before the preoperative training program
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body mass index (BMI)
時間枠：through preoperative training program completion (15 sessions)
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weight in kilograms divided by the square of height in meters
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through preoperative training program completion (15 sessions)
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fat-free mass
時間枠：before the preoperative training program
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impedancemetry (Bodystat® 1500MDD, (5/50 kHz), Bodystat, Douglas, Isle of Man, UK).
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before the preoperative training program
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fat-free mass
時間枠：through preoperative training program completion (15 sessions)
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impedancemetry (Bodystat® 1500MDD, (5/50 kHz), Bodystat, Douglas, Isle of Man, UK).
|
through preoperative training program completion (15 sessions)
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quadriceps peak torque
時間枠：before the preoperative training program
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quadriceps peak torque (in Nm) assessed by dynamometry (MicroFET2®, Hogan Health Industries, Inc., UT)
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before the preoperative training program
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quadriceps peak torque
時間枠：through preoperative training program completion (15 sessions)
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quadriceps peak torque (in Nm) assessed by dynamometry (MicroFET2®, Hogan Health Industries, Inc., UT)
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through preoperative training program completion (15 sessions)
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maximum inspiratory pressure (MIP)
時間枠：before the preoperative training program
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Maximum negative oral pressure generated by the patient during inspiration (in cmH2O)
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before the preoperative training program
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maximum inspiratory pressure (MIP)
時間枠：through preoperative training program completion (15 sessions)
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Maximum negative oral pressure generated by the patient during inspiration (in cmH2O)
|
through preoperative training program completion (15 sessions)
|
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Health related quality of life (HRQoL) questionnaire
時間枠：before the preoperative training program
|
Full name of the scale : "European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire and modular supplement for Lung Cancer patients" (EORTC QLQ-C30 / LC13) The EORTC QLQ-C30, is a 30 questions questionnaire developed by the European Organization for Research and Treatment of Cancer, to assess the QoL of cancer patients. It has been translated and validated into over 100 languages and is used in more than 3,000 studies worldwide. For patients with Lung Cancer, a 13 questions modular supplement, the LC-13, is validated. The HRQoL is therefore evaluated by a set of 43 questions gathering all aspects that could be impacted. A raw score is calculated for each dimension and summary score, then standardized from 0 to 100 points. The additional module for Lung Cancer (LC-13) provides a complementary dimension with specific items related to the tumor site. (see Fayers et. al., The EORTC QLQ-C30 Scoring Manual (3rd Edition) 2001. |
before the preoperative training program
|
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Health related quality of life (HRQoL) questionnaire
時間枠：through preoperative training program completion (15 sessions)
|
Full name of the scale : "European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire and modular supplement for Lung Cancer patients" (EORTC QLQ-C30 / LC13) The EORTC QLQ-C30, is a 30 questions questionnaire developed by the European Organization for Research and Treatment of Cancer, to assess the QoL of cancer patients. It has been translated and validated into over 100 languages and is used in more than 3,000 studies worldwide. For patients with Lung Cancer, a 13 questions modular supplement, the LC-13, is validated. The HRQoL is therefore evaluated by a set of 43 questions gathering all aspects that could be impacted. A raw score is calculated for each dimension and summary score, then standardized from 0 to 100 points. The additional module for Lung Cancer (LC-13) provides a complementary dimension with specific items related to the tumor site. (see Fayers et. al., The EORTC QLQ-C30 Scoring Manual (3rd Edition) 2001. |
through preoperative training program completion (15 sessions)
|
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Adherence to sessions
時間枠：through preoperative training program completion (15 sessions)
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number of sessions performed on number of sessions planned
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through preoperative training program completion (15 sessions)
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Postoperative Complications
時間枠：At 30 days post-intervention
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number and type of complication during the 30 days post lung resection.
Each complication severity is evaluated with the Clavien-Dindo scale.
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At 30 days post-intervention
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スポンサー
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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
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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
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非小細胞肺がんの臨床試験
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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
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Bahçeşehir UniversityNevsehir Haci Bektas Veli Universityまだ募集していません