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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)

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ClinicalTrials.gov Identifier: NCT03936764
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
ADIR Association

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.


Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Other: Preoperative Pulmonary Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Two Different Preoperative Training Densities in Patients With Non-small-cell Lung Cancer Before Lung Resection Surgery
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Group 1
5 Preoperative Pulmonary Rehabilitation sessions / week during 3 weeks.
Other: 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.

Group 2
3 Preoperative Pulmonary Rehabilitation sessions / week during 5 weeks.
Other: 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.




Primary Outcome Measures :
  1. peak dioxyen consumption (VO2peak) [ Time Frame: before the preoperative training program ]
    VO2peak (in ml/kg/min) measured during and incremental Cardio-Pulmonary Exercise Testing (CPET)

  2. peak dioxyen consumption (VO2peak) [ Time Frame: through preoperative training program completion (15 sessions) ]
    VO2peak (in ml/kg/min) measured during and incremental Cardio-Pulmonary Exercise Testing (CPET)


Secondary Outcome Measures :
  1. peak work-rate (WRpeak) [ Time Frame: before the preoperative training program ]
    maximum power reached during the Cardio-Pulmonary Exercise Testing (CPET)

  2. peak work-rate (WRpeak) [ Time Frame: through preoperative training program completion (15 sessions) ]
    maximum power reached during the Cardio-Pulmonary Exercise Testing (CPET)

  3. oxygen consumption at ventilatory threshold (VO2vt) [ Time Frame: before the preoperative training program ]
    oxygen consumption at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)

  4. oxygen consumption at ventilatory threshold (VO2vt) [ Time Frame: through preoperative training program completion (15 sessions) ]
    oxygen consumption at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)

  5. work-rate at ventilatory threshold (WRvt) [ Time Frame: before the preoperative training program ]
    work-rate at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)

  6. work-rate at ventilatory threshold (WRvt) [ Time Frame: through preoperative training program completion (15 sessions) ]
    work-rate at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)

  7. ventilatory efficiency (VE/VCO2 slope) [ Time Frame: 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)

  8. ventilatory efficiency (VE/VCO2 slope) [ Time Frame: 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)

  9. body mass index (BMI) [ Time Frame: before the preoperative training program ]
    weight in kilograms divided by the square of height in meters

  10. body mass index (BMI) [ Time Frame: through preoperative training program completion (15 sessions) ]
    weight in kilograms divided by the square of height in meters

  11. fat-free mass [ Time Frame: before the preoperative training program ]
    impedancemetry (Bodystat® 1500MDD, (5/50 kHz), Bodystat, Douglas, Isle of Man, UK).

  12. fat-free mass [ Time Frame: through preoperative training program completion (15 sessions) ]
    impedancemetry (Bodystat® 1500MDD, (5/50 kHz), Bodystat, Douglas, Isle of Man, UK).

  13. quadriceps peak torque [ Time Frame: before the preoperative training program ]
    quadriceps peak torque (in Nm) assessed by dynamometry (MicroFET2®, Hogan Health Industries, Inc., UT)

  14. quadriceps peak torque [ Time Frame: through preoperative training program completion (15 sessions) ]
    quadriceps peak torque (in Nm) assessed by dynamometry (MicroFET2®, Hogan Health Industries, Inc., UT)

  15. maximum inspiratory pressure (MIP) [ Time Frame: before the preoperative training program ]
    Maximum negative oral pressure generated by the patient during inspiration (in cmH2O)

  16. maximum inspiratory pressure (MIP) [ Time Frame: through preoperative training program completion (15 sessions) ]
    Maximum negative oral pressure generated by the patient during inspiration (in cmH2O)

  17. Health related quality of life (HRQoL) questionnaire [ Time Frame: 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.


  18. Health related quality of life (HRQoL) questionnaire [ Time Frame: 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.


  19. Adherence to sessions [ Time Frame: through preoperative training program completion (15 sessions) ]
    number of sessions performed on number of sessions planned

  20. Postoperative Complications [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936764


Contacts
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Contact: Francis-Edouard GRAVIER, MSc +33235592970 kine@adir-hautenormandie.com

Locations
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France
ADIR Association Recruiting
Bois-Guillaume, Normandie, France, 76230
Contact: Francis-Edouard FE GRAVIER, MSc    +33235592970    kine@adir-hautenormandie.com   
Principal Investigator: Antoine CUVELIER, MD, PhD         
Sub-Investigator: Francis-Edouard GRAVIER, MSc         
Sub-Investigator: Tristan BONNEVIE, MSc         
Sub-Investigator: Jean-François MUIR, MD         
Sub-Investigator: David DEBEAUMONT, MD         
Sponsors and Collaborators
ADIR Association
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Responsible Party: ADIR Association
ClinicalTrials.gov Identifier: NCT03936764    
Other Study ID Numbers: Preo-Dens
ID-RCB : 2018-A03301-54 ( Registry Identifier: 2018-A03301-54 )
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ADIR Association:
NSCLC
Preoperative pulmonary rehabilitation
Preoperative training
Prehabilitation
Lung resection
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms