RePox-1: Correction of Exercise-induced Desaturation by Acute Oxygen Supply and Exercise Responses in COPD

Sponsor
5 Santé (Other)
Overall Status
Completed
CT.gov ID
NCT02055885
Collaborator
(none)
255
2
16.9
127.5
7.5

Study Details

Study Description

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 Intervention/Treatment Phase

    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:
    1. 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 Design

    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 :
    Feb 1, 2014
    Actual Primary Completion Date :
    Feb 1, 2014
    Actual Study Completion Date :
    Jul 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    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%.

    Outcome Measures

    Primary Outcome Measures

    1. Distance of six minute walking test (meter) [Baseline]

    Secondary Outcome Measures

    1. Dyspnea during the 6 minute walking test [Baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinique du Souffle La Vallonie Lodeve France 34800
    2 Clinique du Souffle La Solane Osséjà France 66340

    Sponsors and Collaborators

    • 5 Santé

    Investigators

    • Study Director: Nelly N HERAUD, Pd-D, 5 Santé

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    5 Santé
    ClinicalTrials.gov Identifier:
    NCT02055885
    Other Study ID Numbers:
    • Fvie_RePox-1
    First Posted:
    Feb 5, 2014
    Last Update Posted:
    Jul 8, 2015
    Last Verified:
    Jul 1, 2015

    Study Results

    No Results Posted as of Jul 8, 2015