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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)

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Preoperative Pulmonary Rehabilitation
Sponsored by
ADIR Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non-Small Cell Lung Cancer focused on measuring NSCLC, Preoperative pulmonary rehabilitation, Preoperative training, Prehabilitation, Lung resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ADIR Association

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group 1

Group 2

Arm Description

5 Preoperative Pulmonary Rehabilitation sessions / week during 3 weeks.

3 Preoperative Pulmonary Rehabilitation sessions / week during 5 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 30, 2019
Last Updated
August 2, 2021
Sponsor
ADIR Association
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1. Study Identification

Unique Protocol Identification Number
NCT03936764
Brief Title
Effect of Two Different Preoperative Training Densities in Patients With Non-small-cell Lung Cancer Before Lung Resection Surgery
Acronym
Preo-Dens
Official Title
Effect of Two Different Preoperative Training Densities in Patients With Non-small-cell Lung Cancer Before Lung Resection Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
May 19, 2021 (Actual)
Study Completion Date
June 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ADIR Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
NSCLC, Preoperative pulmonary rehabilitation, Preoperative training, Prehabilitation, Lung resection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Other
Arm Description
5 Preoperative Pulmonary Rehabilitation sessions / week during 3 weeks.
Arm Title
Group 2
Arm Type
Other
Arm Description
3 Preoperative Pulmonary Rehabilitation sessions / week during 5 weeks.
Intervention Type
Other
Intervention Name(s)
Preoperative Pulmonary Rehabilitation
Intervention Description
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 Measure Information:
Title
peak dioxyen consumption (VO2peak)
Description
VO2peak (in ml/kg/min) measured during and incremental Cardio-Pulmonary Exercise Testing (CPET)
Time Frame
before the preoperative training program
Title
peak dioxyen consumption (VO2peak)
Description
VO2peak (in ml/kg/min) measured during and incremental Cardio-Pulmonary Exercise Testing (CPET)
Time Frame
through preoperative training program completion (15 sessions)
Secondary Outcome Measure Information:
Title
peak work-rate (WRpeak)
Description
maximum power reached during the Cardio-Pulmonary Exercise Testing (CPET)
Time Frame
before the preoperative training program
Title
peak work-rate (WRpeak)
Description
maximum power reached during the Cardio-Pulmonary Exercise Testing (CPET)
Time Frame
through preoperative training program completion (15 sessions)
Title
oxygen consumption at ventilatory threshold (VO2vt)
Description
oxygen consumption at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)
Time Frame
before the preoperative training program
Title
oxygen consumption at ventilatory threshold (VO2vt)
Description
oxygen consumption at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)
Time Frame
through preoperative training program completion (15 sessions)
Title
work-rate at ventilatory threshold (WRvt)
Description
work-rate at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)
Time Frame
before the preoperative training program
Title
work-rate at ventilatory threshold (WRvt)
Description
work-rate at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)
Time Frame
through preoperative training program completion (15 sessions)
Title
ventilatory efficiency (VE/VCO2 slope)
Description
linear regression of the ratio between the increase in minute ventilation and the expired carbon dioxide flow (VE/VCO2 slope)
Time Frame
before the preoperative training program
Title
ventilatory efficiency (VE/VCO2 slope)
Description
linear regression of the ratio between the increase in minute ventilation and the expired carbon dioxide flow (VE/VCO2 slope)
Time Frame
through preoperative training program completion (15 sessions)
Title
body mass index (BMI)
Description
weight in kilograms divided by the square of height in meters
Time Frame
before the preoperative training program
Title
body mass index (BMI)
Description
weight in kilograms divided by the square of height in meters
Time Frame
through preoperative training program completion (15 sessions)
Title
fat-free mass
Description
impedancemetry (Bodystat® 1500MDD, (5/50 kHz), Bodystat, Douglas, Isle of Man, UK).
Time Frame
before the preoperative training program
Title
fat-free mass
Description
impedancemetry (Bodystat® 1500MDD, (5/50 kHz), Bodystat, Douglas, Isle of Man, UK).
Time Frame
through preoperative training program completion (15 sessions)
Title
quadriceps peak torque
Description
quadriceps peak torque (in Nm) assessed by dynamometry (MicroFET2®, Hogan Health Industries, Inc., UT)
Time Frame
before the preoperative training program
Title
quadriceps peak torque
Description
quadriceps peak torque (in Nm) assessed by dynamometry (MicroFET2®, Hogan Health Industries, Inc., UT)
Time Frame
through preoperative training program completion (15 sessions)
Title
maximum inspiratory pressure (MIP)
Description
Maximum negative oral pressure generated by the patient during inspiration (in cmH2O)
Time Frame
before the preoperative training program
Title
maximum inspiratory pressure (MIP)
Description
Maximum negative oral pressure generated by the patient during inspiration (in cmH2O)
Time Frame
through preoperative training program completion (15 sessions)
Title
Health related quality of life (HRQoL) questionnaire
Description
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.
Time Frame
before the preoperative training program
Title
Health related quality of life (HRQoL) questionnaire
Description
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.
Time Frame
through preoperative training program completion (15 sessions)
Title
Adherence to sessions
Description
number of sessions performed on number of sessions planned
Time Frame
through preoperative training program completion (15 sessions)
Title
Postoperative Complications
Description
number and type of complication during the 30 days post lung resection. Each complication severity is evaluated with the Clavien-Dindo scale.
Time Frame
At 30 days post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
ADIR Association
City
Bois-Guillaume
State/Province
Normandie
ZIP/Postal Code
76230
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34952813
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.
Results Reference
derived

Learn more about this trial

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

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