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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
Sponsor:
Information provided by (Responsible Party):
5 Santé

Brief 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

Condition or disease
Chronic Obstructive Pulmonary Disease Oxygen/Therapeutic Use

Detailed 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

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Study Type : Observational
Actual Enrollment : 255 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

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Group/Cohort
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).
negative responders
Negative responders(R-): patients exhibiting a decrease in the distance ≥ 10% and/or an increase in dyspnea ≥ 10%.



Primary Outcome Measures :
  1. Distance of six minute walking test (meter) [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Dyspnea during the 6 minute walking test [ Time Frame: Baseline ]


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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic obstructive pulmonary disease and exhibiting an exercise-induced desaturation during six minute walkink test.
Criteria

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:


Information from the National Library of Medicine

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


Locations
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France
Clinique du Souffle La Vallonie
Lodeve, France, 34800
Clinique du Souffle La Solane
Osséjà, France, 66340
Sponsors and Collaborators
5 Santé
Investigators
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Study Director: Nelly N HERAUD, Pd-D 5 Santé

Publications:
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Responsible Party: 5 Santé
ClinicalTrials.gov Identifier: NCT02055885    
Other Study ID Numbers: Fvie_RePox-1
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases