6-minute Stepper Test and Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronicle Obstructive Pulmonary Disease
NCT ID: NCT04004689
Last Updated: 2023-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
80 participants
OBSERVATIONAL
2019-08-01
2023-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
6-minute Stepper Test and Pulmonary Rehabilitation in Patients With Chronicle Obstructive Pulmonary Disease
NCT02842463
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
NCT04008615
The Six-minute Stepper Test as an Outcome Measure of Exercise Tolerance During Pulmonary Rehabilitation in With Chronic Obstructive Pulmonary Disease (COPD) Patients(STEPPER)?
NCT01759199
Respiratory Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease
NCT03453606
Assessing Functional Capacity in Directly and Remotely Monitored Home-based Settings: A Protocol for a Multinational Validation Study in Individuals With Chronic Respiratory Diseases
NCT06447831
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The validation of the six-minute stepper test to prescribe endurance training in severe to very severe chronicle obstructive pulmonary disease involves two steps :
1. 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.
2. The validity of this predictive equation will be assessed in an independent cross-validation group issued from a completed multicenter observational study (NCT03244137). This cross-validation group will be formed with those patients of this cohort who performed both the incremental cardiopulmonary exercise testing (and had a determined first ventilatory threshold) and the six-minute stepper test. The heart rate prescription for endurance training from the direct measurement of the the first ventilatory threshold will be compared to the heart rate derived from the 6minute-stepper test using the predictive equation determined in step 1. Data will be compared using the mean absolute difference between both prescriptions and a Bland-Altman analysis.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Chronicle obstructive pulmonary disease stage III/IV (FEV1 \< 50%) ;
* Weight ≤ 90kg ;
* Eligible for pulmonary rehabilitation ;
* A first ventilatory threshold has been identified during a previously performed incremental cardiopulmonary exercise testing.
Exclusion Criteria
* 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.).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ADIR Association
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Debeaumont, MD
Role: PRINCIPAL_INVESTIGATOR
CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Catherine Tardif, MD
Role: STUDY_CHAIR
CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
Antoine Cuvelier, Prof, PhD
Role: STUDY_CHAIR
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.
Tristan Bonnevie, MsC
Role: STUDY_CHAIR
ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
Francis-Edouard Gravier, PT
Role: STUDY_CHAIR
ADIR Association, Bois-Guillaume, France
Catherine Viacroze, MD
Role: STUDY_CHAIR
CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
Jean-François Muir, Prof, PhD
Role: STUDY_CHAIR
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
Bouchra Lamia, Prof, PhD
Role: STUDY_CHAIR
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
Jean Quieffin, MD
Role: STUDY_CHAIR
Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Guillaume Prieur, PT, MsC
Role: STUDY_CHAIR
Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
Clément Médrinal, PT, MsC
Role: STUDY_CHAIR
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
Pierre-Alexandre Hauss, MD
Role: STUDY_CHAIR
Service de pneumologie, Centre Hosptalier Intercommunal Elbeuf-Louviers-Val de Reuil
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ADIR Association
Bois-Guillaume, , France
Centre Hostalier Intercommunal Elbeuf-Louviers-Val de Reuil
Elbeuf, , France
Groupe Hospitalier du Havre
Le Havre, , France
Centre Hospitalier de Morlaix
Morlaix, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Pierre-Alexandre Hauss, MD
Role: primary
Clément Médrinal, MD
Role: primary
Marc Beaumont, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6STaR-2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.