Correction of Exercise-induced Desaturation by Acute Oxygen Supply and Exercise Responses in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

— RePox-1  

Official title:

Does Correction of Exercice-induced Desaturation by O2 Improve Systematically Exercise Tolerance in COPD Patients ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055885
• Other study ID #: Fvie_RePox-1
• Status: Completed
• Phase: N/A
• First received: February 4, 2014
• Last updated: July 7, 2015
• Start date: February 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: 5 Santé
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministère de l'Enseignement supérieur et de la Recherche
• Study type: Observational

Clinical Trial Summary

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 :

1. 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.

2. To identify the predictive factors among the clinical data (i.e., anthropometric, spirometric and gazometric data) and/or functional data recorded during rehabilitation program

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: July 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Oxygen/Therapeutic Use
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
France	Clinique du Souffle La Vallonie	Lodeve
France	Clinique du Souffle La Solane	Osséjà

Sponsors (1)

Lead Sponsor	Collaborator
5 Santé

Country where clinical trial is conducted

France, 

References & Publications (1)

Héraud N, Préfaut C, Durand F, Varray A. Does correction of exercise-induced desaturation by O(2) always improve exercise tolerance in COPD? A preliminary study. Respir Med. 2008 Sep;102(9):1276-86. doi: 10.1016/j.rmed.2008.04.005. Epub 2008 Jul 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance of six minute walking test (meter)		Baseline	No
Secondary	Dyspnea during the 6 minute walking test		Baseline	No