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). |
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:
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 |
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 |
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. |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tristan Bonnevie, MsC | 02 65 59 29 70 ext +33 | rehabilitation@adir-hautenormandie.com |
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 |
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 | |||||||||||||||||||||||||||||||||||||
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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 |
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.
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Original Primary Outcome Measures | Same as current | ||||||||||||||||||||||||||||||||||||
Change History | |||||||||||||||||||||||||||||||||||||
Current Secondary Outcome Measures |
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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. |
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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:
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. |
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Study Type | Observational | ||||||||||||||||||||||||||||||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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 |
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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. |
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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).
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Publications * | Not Provided | ||||||||||||||||||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||||||||||||||||||
Recruitment Status | Recruiting | ||||||||||||||||||||||||||||||||||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||||||||||||||||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||||||||||
Contacts |
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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 |
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IPD Sharing Statement | Not Provided | ||||||||||||||||||||||||||||||||||||
Responsible Party | ADIR Association | ||||||||||||||||||||||||||||||||||||
Study Sponsor | ADIR Association | ||||||||||||||||||||||||||||||||||||
Collaborators | Not Provided | ||||||||||||||||||||||||||||||||||||
Investigators |
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PRS Account | ADIR Association | ||||||||||||||||||||||||||||||||||||
Verification Date | January 2021 |