- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Lodeve, Frankreich, 34800
- Clinique du Souffle la Vallonie
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Osséjà, Frankreich, 66340
- Clinique du Souffle la Solane
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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:
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Distance of six minute walking test (meter)
Zeitfenster: Baseline
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Baseline
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Dyspnea during the 6 minute walking test
Zeitfenster: Baseline
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Baseline
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Nelly N HERAUD, Pd-D, 5 Santé
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Fvie_RePox-1
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