Effects Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome

Acute Effects of 40% Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome


Lead Sponsor: Federal University of São Paulo

Source Federal University of São Paulo
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.

Overall Status Completed
Start Date 2012-01-01
Completion Date 2014-06-01
Primary Completion Date 2014-06-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Distance walked during the six-minute walk tests At enrollment
Enrollment 30

Intervention Type: Other

Intervention Name: Oxygen Supplementation

Description: Oxygen delivery was continuous by mask at 40%

Arm Group Label: Oxygen Supplementation



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



Minimum Age:

18 Years

Maximum Age:

60 Years

Healthy Volunteers:


Overall Official
Last Name Role Affiliation
Laion Gonzaga, PT Principal Investigator Federal University of Sao Paulo
Verification Date


Responsible Party

Type: Principal Investigator

Investigator Affiliation: Federal University of São Paulo

Investigator Full Name: Laion rodrigo do Amaral Gonzaga

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Oxygen Supplementation

Type: Experimental

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.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

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