Clinical trial NCT03936764: Effect of Two Different Preoperative Training Densities in Patients With Non-small-cell Lung Cancer Before Lung Resection Surgery
Official title: Effect of Two Different Preoperative Training Densities in Patients With Non-small-cell Lung Cancer Before Lung Resection Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC
Preoperative pulmonary rehabilitation
Preoperative training
Prehabilitation
Lung resection
Lead sponsor: ADIR Association
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: peak dioxyen consumption (VO2peak)
timeFrame: before the preoperative training program
measure: peak dioxyen consumption (VO2peak)
timeFrame: through preoperative training program completion (15 sessions)
Secondary outcomes:
measure: peak work-rate (WRpeak)
timeFrame: before the preoperative training program
measure: peak work-rate (WRpeak)
timeFrame: through preoperative training program completion (15 sessions)
measure: oxygen consumption at ventilatory threshold (VO2vt)
timeFrame: before the preoperative training program
measure: oxygen consumption at ventilatory threshold (VO2vt)
timeFrame: through preoperative training program completion (15 sessions)
measure: work-rate at ventilatory threshold (WRvt)
timeFrame: before the preoperative training program
measure: work-rate at ventilatory threshold (WRvt)
timeFrame: through preoperative training program completion (15 sessions)
measure: ventilatory efficiency (VE/VCO2 slope)
timeFrame: before the preoperative training program
measure: ventilatory efficiency (VE/VCO2 slope)
timeFrame: through preoperative training program completion (15 sessions)
measure: body mass index (BMI)
timeFrame: before the preoperative training program
measure: body mass index (BMI)
timeFrame: through preoperative training program completion (15 sessions)
measure: fat-free mass
timeFrame: before the preoperative training program
measure: fat-free mass
timeFrame: through preoperative training program completion (15 sessions)
measure: quadriceps peak torque
timeFrame: before the preoperative training program
measure: quadriceps peak torque
timeFrame: through preoperative training program completion (15 sessions)
measure: maximum inspiratory pressure (MIP)
timeFrame: before the preoperative training program
measure: maximum inspiratory pressure (MIP)
timeFrame: through preoperative training program completion (15 sessions)
measure: Health related quality of life (HRQoL) questionnaire
timeFrame: before the preoperative training program
measure: Health related quality of life (HRQoL) questionnaire
timeFrame: through preoperative training program completion (15 sessions)
measure: Adherence to sessions
timeFrame: through preoperative training program completion (15 sessions)
measure: Postoperative Complications
timeFrame: At 30 days post-intervention
Other outcomes:
Locations:
city: Bois-Guillaume
country: France
facility: ADIR Association
state: Normandie
Study officials:
References:
citation: Gravier FE, Smondack P, Boujibar F, Prieur G, Medrinal C, Combret Y, Muir JF, Baste JM, Cuvelier A, Debeaumont D, Bonnevie T. Prehabilitation sessions can be provided more frequently in a shortened regimen with similar or better efficacy in people with non-small cell lung cancer: a randomised trial. J Physiother. 2022 Jan;68(1):43-50. doi: 10.1016/j.jphys.2021.12.010. Epub 2021 Dec 21.