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
About this trial
This is an interventional supportive care trial for Eisenmenger Complex
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
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
NCT ID
NCT02661802
First Posted
January 20, 2016
Last Updated
January 22, 2016
Sponsor
Federal University of São Paulo
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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