Informations générales (source: ClinicalTrials.gov)
Use of the 6-minute Stepper Test to Individualise Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronicle Obstructive Pulmonary Disease (6STaR-2)
Observational
ADIR Association (Voir sur ClinicalTrials)
août 2019
septembre 2023
08 février 2025
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier de Morlaix - Morlaix - France | Marc Beaumont, PhD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| ADIR Association - Bois-Guillaume - France | Tristan Bonnevie | Contact (sur clinicalTrials) | |||
| Centre Hostalier Intercommunal Elbeuf-Louviers-Val de Reuil - Elbeuf - France | Pierre-Alexandre Hauss, MD | Contact (sur clinicalTrials) | |||
| Groupe Hospitalier du Havre - Le Havre - France | Clément Médrinal, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Age > 18 ans ;
- 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.
- Age > 18 ans ;
- 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.
- 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.).