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 cardiopulmonary exercise testing to determine both the optimal training settings as well as any cardiopulmonary contraindications to pulmonary rehabilitation. However, this 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 6-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 aim of this study was to develop and validate a prediction equation to set rehabilitation intensity for patients with severe to very severe chronicle obstructive pulmonary disease attending pulmonary rehabilitation, with the use of a simple, readily available field test. Therefore the investigators sought to determine, if it exists, a relationship between the plateau heart rate from the first and last 3 minutes of the 6-minute stepper test and the heart rate from the first ventilatory threshold from the cardiopulmonary exercise testing in order to individualize pulmonary rehabilitation in patients with severe to very severe chronicle obstructive pulmonary disease.
Condition or disease | Intervention/treatment |
---|---|
Chronic Obstructive Pulmonary Disease Pulmonary Rehabilitation 6-minute Stepper Test | Other: 2 times : 6-minute stepper test with a rest of 20min between each test. |
Experimental design:
The validation of the six-minute stepper test to prescribe endurance training in severe to very severe chronicle obstructive pulmonary disease involves two steps :
Patients with severe to very severe chronicle obstructive pulmonary disease who performed an incremental cardiopulmonary exercise testing and are referred to pulmonary rehabilitation will be approached to participate in the study.
Eligible patients who agree to participate in the study and sign informed consent will perform two six-minute stepper test. Their performance and heart rate (first and last 3minutes) will be compared with those obtained at the first ventilatory threshold from the previously performed incremental cardiopulmonary exercise testing (usually used for the prescription of endurance training in pulmonary rehabilitation) using multiple regression in order to derive a predictive equation.
Study Type : | Observational |
Estimated Enrollment : | 80 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Use of the 6-minute Stepper Test to Individualise Pulmonary Rehabilitation in Patients With Severe to Very Severe 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 the 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. |
Other: 2 times : 6-minute stepper test with a rest of 20min between each test.
Patients will perform two 6-minute stepper tests separated by a rest period of at least 20 minutes. The second test will begin when the heart rate and the transcutaneous oxygen saturation values will be returned to baseline values. Standardization of the instructions for the test will be based on the actual guidelines for the 6-minute walk test. The test will be performed in an isolated room in order to avoid noise or external stimuli which can affect performance. The stepper will be placed near a door and the patient was allowed to put a hand on it if out of balance or exhausted. The height of the step will be fixed to 20 cm. A step was defined as the rise and lowering of one foot. The patient was informed of the time each minute. No other encouragement was given. Heart rate and transcutaneous oxygen saturation will be continuously recorded by a pulse oximetry. |
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 | |||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date | June 27, 2019 | ||||||||||||||||||||||||||||||||||||
First Posted Date | July 2, 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 |
Relation between plateau heart rate (bpm) from the first and last 3 minutes of the 6-minute stepper test and heart rate (bpm) from first ventilatory threshold from cardiopulmonary exercise testing. [ Time Frame: Heart rate (bpm) will be assessed during cardiopulmonary exercise testing with electrocardiogram. During the 2 6-minute stepper test, heart will be assessed with oximeter. All theses tests wil be carried out in a total time frame of 3 month maximum. ] Outcome (heart rate) during different tests will be continuously recorded. Relation will be adjusted for age and step count.
|
||||||||||||||||||||||||||||||||||||
Original Primary Outcome Measures | Same as current | ||||||||||||||||||||||||||||||||||||
Change History | |||||||||||||||||||||||||||||||||||||
Current Secondary Outcome Measures |
|
||||||||||||||||||||||||||||||||||||
Original Secondary Outcome Measures |
|
||||||||||||||||||||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||||||||||||||||||
Brief Title | 6-minute Stepper Test and Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronicle Obstructive Pulmonary Disease | ||||||||||||||||||||||||||||||||||||
Official Title | Use of the 6-minute Stepper Test to Individualise Pulmonary Rehabilitation in Patients With Severe to Very Severe 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 cardiopulmonary exercise testing to determine both the optimal training settings as well as any cardiopulmonary contraindications to pulmonary rehabilitation. However, this 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 6-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 aim of this study was to develop and validate a prediction equation to set rehabilitation intensity for patients with severe to very severe chronicle obstructive pulmonary disease attending pulmonary rehabilitation, with the use of a simple, readily available field test. Therefore the investigators sought to determine, if it exists, a relationship between the plateau heart rate from the first and last 3 minutes of the 6-minute stepper test and the heart rate from the first ventilatory threshold from the cardiopulmonary exercise testing in order to individualize pulmonary rehabilitation in patients with severe to very severe chronicle obstructive pulmonary disease. |
||||||||||||||||||||||||||||||||||||
Detailed Description |
Experimental design: The validation of the six-minute stepper test to prescribe endurance training in severe to very severe chronicle obstructive pulmonary disease involves two steps :
|
||||||||||||||||||||||||||||||||||||
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 severe to very severe chronicle obstructive pulmonary disease reffered for pulmonary rehabilitation. | ||||||||||||||||||||||||||||||||||||
Condition |
|
||||||||||||||||||||||||||||||||||||
Intervention | Other: 2 times : 6-minute stepper test with a rest of 20min between each test.
Patients will perform two 6-minute stepper tests separated by a rest period of at least 20 minutes. The second test will begin when the heart rate and the transcutaneous oxygen saturation values will be returned to baseline values. Standardization of the instructions for the test will be based on the actual guidelines for the 6-minute walk test. The test will be performed in an isolated room in order to avoid noise or external stimuli which can affect performance. The stepper will be placed near a door and the patient was allowed to put a hand on it if out of balance or exhausted. The height of the step will be fixed to 20 cm. A step was defined as the rise and lowering of one foot. The patient was informed of the time each minute. No other encouragement was given. Heart rate and transcutaneous oxygen saturation will be continuously recorded by a pulse oximetry. |
||||||||||||||||||||||||||||||||||||
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 the 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. Intervention: Other: 2 times : 6-minute stepper test 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 |
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:
|
||||||||||||||||||||||||||||||||||||
Sex/Gender |
|
||||||||||||||||||||||||||||||||||||
Ages | 18 Years and older (Adult, Older Adult) | ||||||||||||||||||||||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||||||||||
Contacts |
|
||||||||||||||||||||||||||||||||||||
Listed Location Countries | France | ||||||||||||||||||||||||||||||||||||
Removed Location Countries | |||||||||||||||||||||||||||||||||||||
Administrative Information | |||||||||||||||||||||||||||||||||||||
NCT Number | NCT04004689 | ||||||||||||||||||||||||||||||||||||
Other Study ID Numbers | 6STaR-2 | ||||||||||||||||||||||||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||||||||||||||||||||||||
U.S. FDA-regulated Product |
|
||||||||||||||||||||||||||||||||||||
IPD Sharing Statement |
|
||||||||||||||||||||||||||||||||||||
Responsible Party | ADIR Association | ||||||||||||||||||||||||||||||||||||
Study Sponsor | ADIR Association | ||||||||||||||||||||||||||||||||||||
Collaborators | Not Provided | ||||||||||||||||||||||||||||||||||||
Investigators |
|
||||||||||||||||||||||||||||||||||||
PRS Account | ADIR Association | ||||||||||||||||||||||||||||||||||||
Verification Date | January 2021 |