- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Lodeve, Francia, 34800
- Clinique du Souffle La Vallonie
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Osséjà, Francia, 66340
- Clinique du Souffle la Solane
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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:
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Distance of six minute walking test (meter)
Lasso di tempo: Baseline
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Baseline
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Dyspnea during the 6 minute walking test
Lasso di tempo: Baseline
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Baseline
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Nelly N HERAUD, Pd-D, 5 Santé
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Fvie_RePox-1
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .