Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02661802
Recruitment Status : Completed
First Posted : January 22, 2016
Last Update Posted : January 25, 2016
Sponsor:
Information provided by (Responsible Party):
Laion rodrigo do Amaral Gonzaga, 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.

Condition or disease Intervention/treatment Phase
Eisenmenger Complex Hypertension, Pulmonary Other: Oxygen Supplementation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Acute Effects of 40% Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome
Study Start Date : January 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Oxygen Supplementation
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.
Other: Oxygen Supplementation
Oxygen delivery was continuous by mask at 40%




Primary Outcome Measures :
  1. Distance walked during the six-minute walk tests [ Time Frame: At enrollment ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02661802


Sponsors and Collaborators
Federal University of São Paulo
Investigators
Layout table for investigator information
Principal Investigator: Laion Gonzaga, PT Federal University of Sao Paulo
Layout table for additonal information
Responsible Party: Laion rodrigo do Amaral Gonzaga, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02661802    
Other Study ID Numbers: 13473813.1.0000.5505
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension, Pulmonary
Eisenmenger Complex
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities