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临床试验/NCT03936764
NCT03936764已完成不适用

Effect of Two Different Preoperative Training Densities in Patients With Non-small-cell Lung Cancer Before Lung Resection Surgery

ADIR Association1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年5月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
peak dioxyen consumption (VO2peak)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Group 1

Other

5 Preoperative Pulmonary Rehabilitation sessions / week during 3 weeks.

干预措施: Preoperative Pulmonary Rehabilitation (Other)

Group 2

Other

3 Preoperative Pulmonary Rehabilitation sessions / week during 5 weeks.

干预措施: Preoperative Pulmonary Rehabilitation (Other)

结局指标

主要结局

peak dioxyen consumption (VO2peak)

时间窗: through preoperative training program completion (15 sessions)

VO2peak (in ml/kg/min) measured during and incremental Cardio-Pulmonary Exercise Testing (CPET)

peak dioxyen consumption (VO2peak)

时间窗: before the preoperative training program

VO2peak (in ml/kg/min) measured during and incremental Cardio-Pulmonary Exercise Testing (CPET)

次要结局

  • fat-free mass(through preoperative training program completion (15 sessions))
  • body mass index (BMI)(through preoperative training program completion (15 sessions))
  • peak work-rate (WRpeak)(through preoperative training program completion (15 sessions))
  • ventilatory efficiency (VE/VCO2 slope)(through preoperative training program completion (15 sessions))
  • work-rate at ventilatory threshold (WRvt)(through preoperative training program completion (15 sessions))
  • quadriceps peak torque(through preoperative training program completion (15 sessions))
  • maximum inspiratory pressure (MIP)(through preoperative training program completion (15 sessions))
  • Health related quality of life (HRQoL) questionnaire(through preoperative training program completion (15 sessions))
  • Postoperative Complications(At 30 days post-intervention)
  • oxygen consumption at ventilatory threshold (VO2vt)(through preoperative training program completion (15 sessions))
  • Adherence to sessions(through preoperative training program completion (15 sessions))
  • peak work-rate (WRpeak)(before the preoperative training program)
  • oxygen consumption at ventilatory threshold (VO2vt)(before the preoperative training program)
  • work-rate at ventilatory threshold (WRvt)(before the preoperative training program)
  • ventilatory efficiency (VE/VCO2 slope)(before the preoperative training program)
  • body mass index (BMI)(before the preoperative training program)
  • fat-free mass(before the preoperative training program)
  • quadriceps peak torque(before the preoperative training program)
  • maximum inspiratory pressure (MIP)(before the preoperative training program)
  • Health related quality of life (HRQoL) questionnaire(before the preoperative training program)

研究者

发起方
ADIR Association
申办方类型
Other
责任方
Sponsor

研究点 (1)

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