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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 augustus 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

36

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Group 1
5 Preoperative Pulmonary Rehabilitation sessions / week during 3 weeks.
Ander: 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.
Ander: Group 2
3 Preoperative Pulmonary Rehabilitation sessions / week during 5 weeks.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
peak dioxyen consumption (VO2peak)
Tijdsspanne: 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)
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
peak work-rate (WRpeak)
Tijdsspanne: before the preoperative training program
maximum power reached during the Cardio-Pulmonary Exercise Testing (CPET)
before the preoperative training program
peak work-rate (WRpeak)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

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Sponsor

ADIR Association

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 mei 2019

Primaire voltooiing (Werkelijk)

19 mei 2021

Studie voltooiing (Werkelijk)

16 juni 2021

Studieregistratiedata

Eerst ingediend

30 april 2019

Eerst ingediend dat voldeed aan de QC-criteria

1 mei 2019

Eerst geplaatst (Werkelijk)

3 mei 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 augustus 2021

Laatste update ingediend die voldeed aan QC-criteria

2 augustus 2021

Laatst geverifieerd

1 augustus 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Preo-Dens
  • ID-RCB : 2018-A03301-54 (Register-ID: 2018-A03301-54)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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