- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02055885
Correction of Exercise-induced Desaturation by Acute Oxygen Supply and Exercise Responses in COPD (RePox-1)
Does Correction of Exercice-induced Desaturation by O2 Improve Systematically Exercise Tolerance in COPD Patients ?
In the literature, the effects of acute oxygen administration on exercise tolerance and related symptoms have often appeared to be contradictory. Some investigations have reported benefits from acute oxygen supply during exertion, including increased exercise performance, reduced dyspnea, and better cardiorespiratory adaptations, whereas other studies have reported no improvement. Recently, we advanced then the hypothesis that some patients would be non-responders and even worsen under oxygen treatment. The preliminary results confirmed our hypothesis since we demonstrated that while 56% of the patients were improved with supplemental oxygen, 16% were non-responders and 28% were negative-responders (decreased performance and increased dyspnea during endurance exercise with supplemental oxygen). However, this was a pilot study offering preliminary insights and tentative conclusions that must be confirmed in a larger case series.
The aims of this retrospective study was :
- To confirm on cohorte and with clinical test (the 6-minute walking test - 6WT) the deleterious responses to acute oxygen supplementation in LTOT (long terme oxygenotherapy treatment) and non-LTOT patients who exhibit exercise desaturation.
- To identify the predictive factors among the clinical data (i.e., anthropometric, spirometric and gazometric data) and/or functional data recorded during rehabilitation program
Aperçu de l'étude
Statut
Les conditions
Description détaillée
During this study, a retrospective data collection will be carried out using the informations contained in the medical folders of patients admitted in our centers for pulmonary rehabiliation program.
We will select patients who meet the following criteria:
A) patients having two 6WT early in their program B) who desaturate (SpO2 <90% for 3 consecutive min) during the first 6WT and who will have been properly corrected with a supply of oxygen during the second walk test.
The analyzed parameters will be distance and dyspnea during the tests
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Lodeve, France, 34800
- Clinique du Souffle La Vallonie
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Osséjà, France, 66340
- Clinique du Souffle la Solane
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Obstructive airflow limitation defined by FEV1/CVF < 70% and FEV1 < 80 %
- Patients with or without long terme oxygenotherapy
- Patients exhibited during the first test, an exercise-induced desaturation, defined by SaO2 < 90% for 3 consecutive minutes during the 6-minute walking test in the air condition for non-LTOT or with the flow normally recommended during exercise for LTOT patients (i.e., flow rate of rest + 1L/min)
- Patients with no desaturation during the test with oxygen supply
Exclusion Criteria:
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Positive responders
Positive responders (R+): patients exhibiting an increase in the 6WT distance ≥ 10% and/or a decrease in dyspnea ≥ 10% (i.e., ≥ 1 point on the visual analogue scale).
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negative responders
Negative responders(R-): patients exhibiting a decrease in the distance ≥ 10% and/or an increase in dyspnea ≥ 10%.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Distance of six minute walking test (meter)
Délai: Baseline
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Baseline
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Dyspnea during the 6 minute walking test
Délai: Baseline
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Baseline
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Nelly N HERAUD, Pd-D, 5 Santé
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Fvie_RePox-1
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