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

2 de agosto de 2021 actualizado por: ADIR Association

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

36

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Group 1
5 Preoperative Pulmonary Rehabilitation sessions / week during 3 weeks.
Otro: Preoperative Pulmonary Rehabilitation

Each prehabilitation session will last approximately 90 minutes and will include:

  • Endurance training at the ventilatory threshold, determined according to the initial CPET. The first session will last for 15 to 20 minutes then increase by 5 minutes each session to reach 45 minutes in total (including a 5-minute warm-up and 5 minutes of active recovery). The intensity will then increase by 5 or 10 W, as could be tolerated;
  • Peripheral muscle strengthening at 60% to 70% of the 1-repetition maximum of 3 main components (quadriceps press, whole-leg extension, and upper limb pull down). Three sets of 12 movements will carry out for each exercise and the load will increase weekly as tolerated;
  • Inspiratory muscle training using a threshold calibrated to at least 30% of the MIP. Patients will be encouraged to carry out 15 minutes of independent training daily and to increase the resistance regularly.
  • Education to bronchial drainage techniques as well as directed coughing.
Otro: Group 2
3 Preoperative Pulmonary Rehabilitation sessions / week during 5 weeks.
Otro: Preoperative Pulmonary Rehabilitation

Each prehabilitation session will last approximately 90 minutes and will include:

  • Endurance training at the ventilatory threshold, determined according to the initial CPET. The first session will last for 15 to 20 minutes then increase by 5 minutes each session to reach 45 minutes in total (including a 5-minute warm-up and 5 minutes of active recovery). The intensity will then increase by 5 or 10 W, as could be tolerated;
  • Peripheral muscle strengthening at 60% to 70% of the 1-repetition maximum of 3 main components (quadriceps press, whole-leg extension, and upper limb pull down). Three sets of 12 movements will carry out for each exercise and the load will increase weekly as tolerated;
  • Inspiratory muscle training using a threshold calibrated to at least 30% of the MIP. Patients will be encouraged to carry out 15 minutes of independent training daily and to increase the resistance regularly.
  • Education to bronchial drainage techniques as well as directed coughing.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
peak dioxyen consumption (VO2peak)
Periodo de tiempo: before the preoperative training program
VO2peak (in ml/kg/min) measured during and incremental Cardio-Pulmonary Exercise Testing (CPET)
before the preoperative training program
peak dioxyen consumption (VO2peak)
Periodo de tiempo: through preoperative training program completion (15 sessions)
VO2peak (in ml/kg/min) measured during and incremental Cardio-Pulmonary Exercise Testing (CPET)
through preoperative training program completion (15 sessions)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
peak work-rate (WRpeak)
Periodo de tiempo: before the preoperative training program
maximum power reached during the Cardio-Pulmonary Exercise Testing (CPET)
before the preoperative training program
peak work-rate (WRpeak)
Periodo de tiempo: through preoperative training program completion (15 sessions)
maximum power reached during the Cardio-Pulmonary Exercise Testing (CPET)
through preoperative training program completion (15 sessions)
oxygen consumption at ventilatory threshold (VO2vt)
Periodo de tiempo: before the preoperative training program
oxygen consumption at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)
before the preoperative training program
oxygen consumption at ventilatory threshold (VO2vt)
Periodo de tiempo: through preoperative training program completion (15 sessions)
oxygen consumption at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)
through preoperative training program completion (15 sessions)
work-rate at ventilatory threshold (WRvt)
Periodo de tiempo: before the preoperative training program
work-rate at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)
before the preoperative training program
work-rate at ventilatory threshold (WRvt)
Periodo de tiempo: through preoperative training program completion (15 sessions)
work-rate at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)
through preoperative training program completion (15 sessions)
ventilatory efficiency (VE/VCO2 slope)
Periodo de tiempo: before the preoperative training program
linear regression of the ratio between the increase in minute ventilation and the expired carbon dioxide flow (VE/VCO2 slope)
before the preoperative training program
ventilatory efficiency (VE/VCO2 slope)
Periodo de tiempo: through preoperative training program completion (15 sessions)
linear regression of the ratio between the increase in minute ventilation and the expired carbon dioxide flow (VE/VCO2 slope)
through preoperative training program completion (15 sessions)
body mass index (BMI)
Periodo de tiempo: before the preoperative training program
weight in kilograms divided by the square of height in meters
before the preoperative training program
body mass index (BMI)
Periodo de tiempo: through preoperative training program completion (15 sessions)
weight in kilograms divided by the square of height in meters
through preoperative training program completion (15 sessions)
fat-free mass
Periodo de tiempo: before the preoperative training program
impedancemetry (Bodystat® 1500MDD, (5/50 kHz), Bodystat, Douglas, Isle of Man, UK).
before the preoperative training program
fat-free mass
Periodo de tiempo: through preoperative training program completion (15 sessions)
impedancemetry (Bodystat® 1500MDD, (5/50 kHz), Bodystat, Douglas, Isle of Man, UK).
through preoperative training program completion (15 sessions)
quadriceps peak torque
Periodo de tiempo: before the preoperative training program
quadriceps peak torque (in Nm) assessed by dynamometry (MicroFET2®, Hogan Health Industries, Inc., UT)
before the preoperative training program
quadriceps peak torque
Periodo de tiempo: through preoperative training program completion (15 sessions)
quadriceps peak torque (in Nm) assessed by dynamometry (MicroFET2®, Hogan Health Industries, Inc., UT)
through preoperative training program completion (15 sessions)
maximum inspiratory pressure (MIP)
Periodo de tiempo: before the preoperative training program
Maximum negative oral pressure generated by the patient during inspiration (in cmH2O)
before the preoperative training program
maximum inspiratory pressure (MIP)
Periodo de tiempo: through preoperative training program completion (15 sessions)
Maximum negative oral pressure generated by the patient during inspiration (in cmH2O)
through preoperative training program completion (15 sessions)
Health related quality of life (HRQoL) questionnaire
Periodo de tiempo: 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
Health related quality of life (HRQoL) questionnaire
Periodo de tiempo: 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)
Adherence to sessions
Periodo de tiempo: through preoperative training program completion (15 sessions)
number of sessions performed on number of sessions planned
through preoperative training program completion (15 sessions)
Postoperative Complications
Periodo de tiempo: At 30 days post-intervention
number and type of complication during the 30 days post lung resection. Each complication severity is evaluated with the Clavien-Dindo scale.
At 30 days post-intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

ADIR Association

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

7 de mayo de 2019

Finalización primaria (Actual)

19 de mayo de 2021

Finalización del estudio (Actual)

16 de junio de 2021

Fechas de registro del estudio

Enviado por primera vez

30 de abril de 2019

Primero enviado que cumplió con los criterios de control de calidad

1 de mayo de 2019

Publicado por primera vez (Actual)

3 de mayo de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de agosto de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

2 de agosto de 2021

Última verificación

1 de agosto de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Preo-Dens
  • ID-RCB : 2018-A03301-54 (Identificador de registro: 2018-A03301-54)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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