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Effects Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome

Primary Purpose

Eisenmenger Complex, Hypertension, Pulmonary

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oxygen Supplementation
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Eisenmenger Complex

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Abscence of heart failure and/or respiratory infection
  • Advanced therapy for pulmonary hypertension

Exclusion Criteria:

  • Lung, liver or connective tissue diseases
  • Neuromuscular diseases
  • Inability to perform a pulmonary function test and/or chronic lung disease
  • Inability to walk

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Oxygen Supplementation

    Arm Description

    Two six-minute walk tests, one with oxygen supplementation and another without were performed on different days. During the test with oxygen supplementation the delivery was continuous by mask at 40% and technician walked behind the patient with the oxygen source.

    Outcomes

    Primary Outcome Measures

    Distance walked during the six-minute walk tests
    Distance walked during the six-minute walk tests with and without oxygen supplementation were recorded and compared to each other to establish the impact of the intervention.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 20, 2016
    Last Updated
    January 22, 2016
    Sponsor
    Federal University of São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02661802
    Brief Title
    Effects Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome
    Official Title
    Acute Effects of 40% Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate the acute effects of oxygen supplementation during a submaximal exercise test in patients with Eisenmenger's Syndrome.
    Detailed Description
    Patients with Eisenmenger's syndrome were submitted to a submaximal exercise test (six-minute walking test) with and without supplemental oxygen. The distance walked during the two tests were compared to assess the impact of oxygen supplementation on the walking distance.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eisenmenger Complex, Hypertension, Pulmonary

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oxygen Supplementation
    Arm Type
    Experimental
    Arm Description
    Two six-minute walk tests, one with oxygen supplementation and another without were performed on different days. During the test with oxygen supplementation the delivery was continuous by mask at 40% and technician walked behind the patient with the oxygen source.
    Intervention Type
    Other
    Intervention Name(s)
    Oxygen Supplementation
    Intervention Description
    Oxygen delivery was continuous by mask at 40%
    Primary Outcome Measure Information:
    Title
    Distance walked during the six-minute walk tests
    Description
    Distance walked during the six-minute walk tests with and without oxygen supplementation were recorded and compared to each other to establish the impact of the intervention.
    Time Frame
    At enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Abscence of heart failure and/or respiratory infection Advanced therapy for pulmonary hypertension Exclusion Criteria: Lung, liver or connective tissue diseases Neuromuscular diseases Inability to perform a pulmonary function test and/or chronic lung disease Inability to walk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laion Gonzaga, PT
    Organizational Affiliation
    Federal University of Sao Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No participant data will be shared. However, all enrolled subjects were provided the principal investigator's phone number and e-mail address in order to receive test results and ask questions.

    Learn more about this trial

    Effects Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome

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