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出境医 / 临床实验 / Comparison of the Cardiopulmonary and Gaz-exchange Response Between the Six-minute Stepper Test and the Incremental Cardiopulmonary Exercise Testing in Patients With Chronicle Obstructive Pulmonary Disease (PH-6MST)

Comparison of the Cardiopulmonary and Gaz-exchange Response Between the Six-minute Stepper Test and the Incremental Cardiopulmonary Exercise Testing in Patients With Chronicle Obstructive Pulmonary Disease (PH-6MST)

Study Description
Brief Summary:

Chronicle obstructive pulmonary disease is a worldwide cause of mortality and morbidity. This systemic disease progressively leads to dyspnea, muscle wasting and exercise capacity impairment.

Pulmonary rehabilitation is a cornerstone in the management of these systemic effects. Unfortunately, access to pulmonary rehabilitation is limited for many people who would benefit from it, primarily because of a lack of pulmonary rehabilitation and assessment centers. Optimal assessment should include an incremental cardiopulmonary exercise testing. This test allows to evaluate the factors contributing to exercise intolerance by linking performance and physiological parameters to the underlying metabolism. Moreover, it is the standard test to determine both the optimal training settings as well as any cardiopulmonary contraindications to pulmonary rehabilitation. However, this test is not available in most centers and when it is, consultations are limited. Therefore, pulmonary rehabilitation is often delayed for several weeks and patients can lose motivation.

In order to promote pulmonary rehabilitation, the incremental cardiopulmonary exercise testing could be replaced by field tests to individualize pulmonary rehabilitation prescription.

The six-minute stepper test is a new field tool. Its sensitivity and reproducibility have previously been reported in patients with chronicle obstructive pulmonary disease. It is easy to set up in the clinical setting and could be used to individualize pulmonary rehabilitation.

The main drawback when using field test is that they only provide a non specific assessement of the functional capacity because cardiopulmonary parameters and gaz exchanges are not monitored.

Although the performance during the 6-minute stepper test is moderately related with the maximal oxygen consumption during the incremental cardiopulmonary exercise testing performed on a cycloergometer, a direct comprehensive comparison of cardiopulmonary parameters and gaz exchanges during these two tests have never been performed.

Moreover, stepping is more closely related with activities of daily life (requiring a repetitive transition from rest to submaximal exercise intensity) than the maximal incremental exercise on cycloergometer and could provide further insight on the disability of patients during their usual activities, such as stair climbing (which is frequently avoided). Additionally, on-transient phase two oxygen consumption kinetic is particularly relevant because it evaluation is independent of the patient's motivation or criteria used to terminate exercise.

Therefore, the aim of this study is to compare the cardiorespiratory parameters, the gaz exchanges and the maximality between the six-minute stepper test and the incremental cardiopulmonary exercise testing performed on a cycloergometer.

The secondary objective was to compare the on-transient oxygen consumption phase two kinetic parameters (time constant, span and steady state) according to the severity of the disease.


Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Pulmonary Rehabilitation 6-minute Stepper Test Other: 2 times : 6-minute stepper test with cardiorespiratory parameters and gaz exchange monitoring (with a rest of 20min between each test).

Detailed Description:

Experimental design:

This study is a pre-specified ancillary study to two other studies (with exactly the same design but a different population) aimed to assess the usability of the six-minute stepper test to prescribe endurance training in patients with mild to moderate (NCT02842463) and severe to very severe (NCT04004689) chronicle obstructive pulmonary disease respectively.

Patients already participating in one of these studies will be approached and offered to participate in an additional testing session (on a different day) using exactly the same procedure but monitoring cardiopulmonary parameters and gaz exchanges using a face mask, a pneumotachograph and a gaz analyser (indirect calorimetry).

Data from these additional two six-minute stepper tests will be compared with those obtained from the previously performed incremental cardiopulmonary exercise testing.

According to the American Thoracic Society and American College of Chest Physicians statement on cardiopulmonary exercise testing, maximality will be considered if either one or more of the following criteria occured:

  1. The patient achieves predicted peak oxygen uptake and/or a plateau is observed.
  2. Predicted maximal heart rate is achieved (>90%)
  3. There is evidence of ventilatory limitation (breathing reserve <11liters or < 15%)
  4. Respiratory exchange ratio > 1.15
  5. Patient exhaustion/Borg Scale rating of 9-10 on a 0-to-10 scale.

Phase II oxygen consumption kinetics will be modelized by averaging the breath by breath measurement over consecutive periods of 5s for using the following monoexponential equation :

VO2 (τ) = VO2rest + VO2ss - VO2rest))*(1-e-t/τ). with " VO2rest " representing the baseline level of VO2 at rest, " VO2ss " representing the steady state of VO2 during exertion and τ (time constant) representing the time course of the monoexponential VO2 curve. The amplitude of the VO2 (VO2span) corresponds to the difference between VO2ss and VO2rest.

A curve by curve analysis will be performed across participants and parameters (time constant, span and steady state oxygen consumption) will be compared according to the stage of severity.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of the Cardiopulmonary and Gaz-exchange Response Between the Six-minute Stepper Test and the Incremental Cardiopulmonary Exercise Testing in Patients With Chronicle Obstructive Pulmonary Disease
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : September 30, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Prospective observational cohort

Every patient referred to pulmonary rehabilitation program will be eligible. They will perform cardiopulmonary exercise testing prior to join rehabilitation program.

During the first session of pulmonary rehabilitation, they will perform 2 6-minute stepper test with a rest of 20 minutes minimum between each test.

For the purpose of this study, patients will be offered to participate in an additional exercise session in which they will repeat the same procedure (two 6-minute stepper test) but but monitoring cardiopulmonary parameters and gaz exchanges using a face mask, a pneumotachograph and a gaz analyser (indirect calorimetry).

Other: 2 times : 6-minute stepper test with cardiorespiratory parameters and gaz exchange monitoring (with a rest of 20min between each test).

For the 6-minute stepper test, please refer to NCT02842463 and NCT04004689. Gaz exchange analyzer will be calibrate before every test. Data will be recorded breath by breath.

Heart rate will be monitored using a 12-lead electrocardiogram. Transcutaneous oxygen saturation will be assessed using a pulse oxymetry system at the earlobe.


Outcome Measures
Primary Outcome Measures :
  1. Oxygen consumption using indirect calorimetry [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The tests will be performed using a face mask, a pneumotachograph and a gaz analyzer.


Secondary Outcome Measures :
  1. Steps during 6-minute stepper test using stepper device. [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
  2. Carbon dioxide production using indirect calorimetry [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The tests will be performed using a face mask, a pneumotachograph and a gaz analyzer.

  3. Heart rate using a 12-lead electrocardiogram [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    Heart rate wil be continuously monitored throughout the tests.

  4. Transcutaneous oxygen saturation using a pulse oxymetry system [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    Transcutaneous oxygen saturation will be continuously monitored throughout the tests at the earlobe.

  5. Tidal volume using a pneumotachograph [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The outcome will be continuously monitored throughout the tests.

  6. Respiratory rate using a pneumotachograph [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The outcome will be continuously monitored throughout the tests.

  7. Minute ventilation using a pneumotachograph [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The outcome will be continuously monitored throughout the tests.

  8. Respiratory exchange ratio using indirect calorimetry [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The outcome will be continuously monitored throughout the tests.

  9. Oxygen equivalent using indirect calorimetry [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The outcome will be continuously monitored throughout the tests and calculated as the ratio between minute ventilation to oxygen consumption

  10. Carbon dioxide equivalent using indirect calorimetry [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The outcome will be continuously monitored throughout the tests and calculated as the ratio between minute ventilation to carbon dioxide production

  11. Ratio between dead space volume to tidal volume using a pneumotachograph and indirect calorimetry [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The outcome will be continuously monitored throughout the tests.

  12. Dyspnea using the Borg scale [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    Borg scale range from 0 (no breathlessness) to 10 (maximal breathlessness)

  13. Lower limb fatigue using the Borg scale [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    Borg scale range from 0 (no breathlessness) to 10 (maximal breathlessness)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronicle obstructive pulmonary disease reffered for pulmonary rehabilitation.
Criteria

Inclusion Criteria:

  • Age > 18 ans ;
  • Chronicle obstructive pulmonary disease stage I/IV ;
  • Weight ≤ 90kg ;
  • Eligible for pulmonary rehabilitation.

Exclusion Criteria:

  • Require during exercise oxygen ;
  • Pregnant woman or likely to be ;
  • Patient under guardianship ;
  • Contraindication to cardiopulmonary exercise testing ;
  • Patient medically treated with heart rate modulator (excluding oral B2-agonist) ;
  • Patient treated with pacemaker or defibrillator ;
  • History of lower limb impairment (i.e. peripheral artery disease, orthopedic disorder etc.).
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Tristan Bonnevie, MsC 02 65 59 29 70 ext +33 rehabilitation@adir-hautenormandie.com

Locations
Layout table for location information
France
ADIR Association Recruiting
Bois-Guillaume, France
Contact: Tristan Bonnevie    02 35 59 27 70    rehabilitation@adir-hautenormandie.com   
Centre Hostalier Intercommunal Elbeuf-Louviers-Val de Reuil Recruiting
Elbeuf, France
Contact: Pierre-Alexandre Hauss, MD         
Groupe Hospitalier du Havre Recruiting
Le Havre, France
Contact: Clément Médrinal, MD         
Sponsors and Collaborators
ADIR Association
Investigators
Layout table for investigator information
Principal Investigator: David Debeaumont, MD CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Study Chair: Catherine Tardif, MD CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Study Chair: Antoine Cuvelier, Prof, PhD CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.
Study Chair: Tristan Bonnevie, MsC ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
Study Chair: Francis-Edouard Gravier, PT ADIR Association, Bois-Guillaume, France
Study Chair: Catherine Viacroze, MD CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
Study Chair: Jean-François Muir, Prof, PhD CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; ADIR Association, Bois-Guillaume, France
Study Chair: Bouchra Lamia, Prof, PhD UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Study Chair: Jean Quieffin, MD Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Study Chair: Guillaume Prieur, PT, MsC Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Study Chair: Clément Médrinal, PT, MsC UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France. Service de réanimation, Groupe Hospitalier du Havre, France
Study Chair: Pierre-Alexandre Hauss, MD Service de pneumologie, Centre Hosptalier Intercommunal Elbeuf-Louviers-Val de Reuil
Tracking Information
First Submitted Date July 2, 2019
First Posted Date July 5, 2019
Last Update Posted Date January 13, 2021
Actual Study Start Date August 1, 2019
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 2, 2019)
Oxygen consumption using indirect calorimetry [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
The tests will be performed using a face mask, a pneumotachograph and a gaz analyzer.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 2, 2019)
  • Steps during 6-minute stepper test using stepper device. [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
  • Carbon dioxide production using indirect calorimetry [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The tests will be performed using a face mask, a pneumotachograph and a gaz analyzer.
  • Heart rate using a 12-lead electrocardiogram [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    Heart rate wil be continuously monitored throughout the tests.
  • Transcutaneous oxygen saturation using a pulse oxymetry system [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    Transcutaneous oxygen saturation will be continuously monitored throughout the tests at the earlobe.
  • Tidal volume using a pneumotachograph [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The outcome will be continuously monitored throughout the tests.
  • Respiratory rate using a pneumotachograph [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The outcome will be continuously monitored throughout the tests.
  • Minute ventilation using a pneumotachograph [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The outcome will be continuously monitored throughout the tests.
  • Respiratory exchange ratio using indirect calorimetry [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The outcome will be continuously monitored throughout the tests.
  • Oxygen equivalent using indirect calorimetry [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The outcome will be continuously monitored throughout the tests and calculated as the ratio between minute ventilation to oxygen consumption
  • Carbon dioxide equivalent using indirect calorimetry [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The outcome will be continuously monitored throughout the tests and calculated as the ratio between minute ventilation to carbon dioxide production
  • Ratio between dead space volume to tidal volume using a pneumotachograph and indirect calorimetry [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    The outcome will be continuously monitored throughout the tests.
  • Dyspnea using the Borg scale [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    Borg scale range from 0 (no breathlessness) to 10 (maximal breathlessness)
  • Lower limb fatigue using the Borg scale [ Time Frame: The 2 6-minute stepper test will be carried out on the same day (20 minute of rest between each test) for a total time frame of 1 day. ]
    Borg scale range from 0 (no breathlessness) to 10 (maximal breathlessness)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of the Cardiopulmonary and Gaz-exchange Response Between the Six-minute Stepper Test and the Incremental Cardiopulmonary Exercise Testing in Patients With Chronicle Obstructive Pulmonary Disease
Official Title Comparison of the Cardiopulmonary and Gaz-exchange Response Between the Six-minute Stepper Test and the Incremental Cardiopulmonary Exercise Testing in Patients With Chronicle Obstructive Pulmonary Disease
Brief Summary

Chronicle obstructive pulmonary disease is a worldwide cause of mortality and morbidity. This systemic disease progressively leads to dyspnea, muscle wasting and exercise capacity impairment.

Pulmonary rehabilitation is a cornerstone in the management of these systemic effects. Unfortunately, access to pulmonary rehabilitation is limited for many people who would benefit from it, primarily because of a lack of pulmonary rehabilitation and assessment centers. Optimal assessment should include an incremental cardiopulmonary exercise testing. This test allows to evaluate the factors contributing to exercise intolerance by linking performance and physiological parameters to the underlying metabolism. Moreover, it is the standard test to determine both the optimal training settings as well as any cardiopulmonary contraindications to pulmonary rehabilitation. However, this test is not available in most centers and when it is, consultations are limited. Therefore, pulmonary rehabilitation is often delayed for several weeks and patients can lose motivation.

In order to promote pulmonary rehabilitation, the incremental cardiopulmonary exercise testing could be replaced by field tests to individualize pulmonary rehabilitation prescription.

The six-minute stepper test is a new field tool. Its sensitivity and reproducibility have previously been reported in patients with chronicle obstructive pulmonary disease. It is easy to set up in the clinical setting and could be used to individualize pulmonary rehabilitation.

The main drawback when using field test is that they only provide a non specific assessement of the functional capacity because cardiopulmonary parameters and gaz exchanges are not monitored.

Although the performance during the 6-minute stepper test is moderately related with the maximal oxygen consumption during the incremental cardiopulmonary exercise testing performed on a cycloergometer, a direct comprehensive comparison of cardiopulmonary parameters and gaz exchanges during these two tests have never been performed.

Moreover, stepping is more closely related with activities of daily life (requiring a repetitive transition from rest to submaximal exercise intensity) than the maximal incremental exercise on cycloergometer and could provide further insight on the disability of patients during their usual activities, such as stair climbing (which is frequently avoided). Additionally, on-transient phase two oxygen consumption kinetic is particularly relevant because it evaluation is independent of the patient's motivation or criteria used to terminate exercise.

Therefore, the aim of this study is to compare the cardiorespiratory parameters, the gaz exchanges and the maximality between the six-minute stepper test and the incremental cardiopulmonary exercise testing performed on a cycloergometer.

The secondary objective was to compare the on-transient oxygen consumption phase two kinetic parameters (time constant, span and steady state) according to the severity of the disease.

Detailed Description

Experimental design:

This study is a pre-specified ancillary study to two other studies (with exactly the same design but a different population) aimed to assess the usability of the six-minute stepper test to prescribe endurance training in patients with mild to moderate (NCT02842463) and severe to very severe (NCT04004689) chronicle obstructive pulmonary disease respectively.

Patients already participating in one of these studies will be approached and offered to participate in an additional testing session (on a different day) using exactly the same procedure but monitoring cardiopulmonary parameters and gaz exchanges using a face mask, a pneumotachograph and a gaz analyser (indirect calorimetry).

Data from these additional two six-minute stepper tests will be compared with those obtained from the previously performed incremental cardiopulmonary exercise testing.

According to the American Thoracic Society and American College of Chest Physicians statement on cardiopulmonary exercise testing, maximality will be considered if either one or more of the following criteria occured:

  1. The patient achieves predicted peak oxygen uptake and/or a plateau is observed.
  2. Predicted maximal heart rate is achieved (>90%)
  3. There is evidence of ventilatory limitation (breathing reserve <11liters or < 15%)
  4. Respiratory exchange ratio > 1.15
  5. Patient exhaustion/Borg Scale rating of 9-10 on a 0-to-10 scale.

Phase II oxygen consumption kinetics will be modelized by averaging the breath by breath measurement over consecutive periods of 5s for using the following monoexponential equation :

VO2 (τ) = VO2rest + VO2ss - VO2rest))*(1-e-t/τ). with " VO2rest " representing the baseline level of VO2 at rest, " VO2ss " representing the steady state of VO2 during exertion and τ (time constant) representing the time course of the monoexponential VO2 curve. The amplitude of the VO2 (VO2span) corresponds to the difference between VO2ss and VO2rest.

A curve by curve analysis will be performed across participants and parameters (time constant, span and steady state oxygen consumption) will be compared according to the stage of severity.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with chronicle obstructive pulmonary disease reffered for pulmonary rehabilitation.
Condition
  • Chronic Obstructive Pulmonary Disease
  • Pulmonary Rehabilitation
  • 6-minute Stepper Test
Intervention Other: 2 times : 6-minute stepper test with cardiorespiratory parameters and gaz exchange monitoring (with a rest of 20min between each test).

For the 6-minute stepper test, please refer to NCT02842463 and NCT04004689. Gaz exchange analyzer will be calibrate before every test. Data will be recorded breath by breath.

Heart rate will be monitored using a 12-lead electrocardiogram. Transcutaneous oxygen saturation will be assessed using a pulse oxymetry system at the earlobe.

Study Groups/Cohorts Prospective observational cohort

Every patient referred to pulmonary rehabilitation program will be eligible. They will perform cardiopulmonary exercise testing prior to join rehabilitation program.

During the first session of pulmonary rehabilitation, they will perform 2 6-minute stepper test with a rest of 20 minutes minimum between each test.

For the purpose of this study, patients will be offered to participate in an additional exercise session in which they will repeat the same procedure (two 6-minute stepper test) but but monitoring cardiopulmonary parameters and gaz exchanges using a face mask, a pneumotachograph and a gaz analyser (indirect calorimetry).

Intervention: Other: 2 times : 6-minute stepper test with cardiorespiratory parameters and gaz exchange monitoring (with a rest of 20min between each test).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 2, 2019)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age > 18 ans ;
  • Chronicle obstructive pulmonary disease stage I/IV ;
  • Weight ≤ 90kg ;
  • Eligible for pulmonary rehabilitation.

Exclusion Criteria:

  • Require during exercise oxygen ;
  • Pregnant woman or likely to be ;
  • Patient under guardianship ;
  • Contraindication to cardiopulmonary exercise testing ;
  • Patient medically treated with heart rate modulator (excluding oral B2-agonist) ;
  • Patient treated with pacemaker or defibrillator ;
  • History of lower limb impairment (i.e. peripheral artery disease, orthopedic disorder etc.).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Tristan Bonnevie, MsC 02 65 59 29 70 ext +33 rehabilitation@adir-hautenormandie.com
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04008615
Other Study ID Numbers PH-6MST
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party ADIR Association
Study Sponsor ADIR Association
Collaborators Not Provided
Investigators
Principal Investigator: David Debeaumont, MD CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Study Chair: Catherine Tardif, MD CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Study Chair: Antoine Cuvelier, Prof, PhD CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.
Study Chair: Tristan Bonnevie, MsC ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
Study Chair: Francis-Edouard Gravier, PT ADIR Association, Bois-Guillaume, France
Study Chair: Catherine Viacroze, MD CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
Study Chair: Jean-François Muir, Prof, PhD CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; ADIR Association, Bois-Guillaume, France
Study Chair: Bouchra Lamia, Prof, PhD UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Study Chair: Jean Quieffin, MD Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Study Chair: Guillaume Prieur, PT, MsC Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Study Chair: Clément Médrinal, PT, MsC UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France. Service de réanimation, Groupe Hospitalier du Havre, France
Study Chair: Pierre-Alexandre Hauss, MD Service de pneumologie, Centre Hosptalier Intercommunal Elbeuf-Louviers-Val de Reuil
PRS Account ADIR Association
Verification Date January 2021

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