Correction of Exercise-induced Desaturation by Acute Oxygen Supply and Exercise Responses in COPD (RePox-1)
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|ClinicalTrials.gov Identifier: NCT02055885|
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : July 8, 2015
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
|Condition or disease|
|Chronic Obstructive Pulmonary Disease Oxygen/Therapeutic Use|
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
|Study Type :||Observational|
|Actual Enrollment :||255 participants|
|Official Title:||Does Correction of Exercice-induced Desaturation by O2 Improve Systematically Exercise Tolerance in COPD Patients ?|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||July 2015|
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).
Negative responders(R-): patients exhibiting a decrease in the distance ≥ 10% and/or an increase in dyspnea ≥ 10%.
- Distance of six minute walking test (meter) [ Time Frame: Baseline ]
- Dyspnea during the 6 minute walking test [ Time Frame: Baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055885
|Clinique du Souffle La Vallonie|
|Lodeve, France, 34800|
|Clinique du Souffle La Solane|
|Osséjà, France, 66340|
|Study Director:||Nelly N HERAUD, Pd-D||5 Santé|