Skip to main content
OpenTrials
Completed

NCT Number: NCT02055885

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique du Souffle La Vallonie, Lodève, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Distance of six minute walking test (meter)

    Time frame: Baseline

Secondary outcomes

  1. Dyspnea during the 6 minute walking test

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

5 Santé

Other

Registry information

Official study title

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

Acronym: RePox-1

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Feb 5, 2014
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.