Six Minutes Walk Test and Shuttle Walk Test in Eisenmenger Syndrome

NCT02752399 | Unknown

• 1 other identifier: 1.462.879
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to verify the applicability Six minutes walk test and Shuttle walk test in assessing functional capacity in patients with Eisenmenger Syndrome. Patients will undergo three functional tests, being the six-minute walk test, shuttle walk test and cardiopulmonary exercise test on a cycle ergometer, associated with evaluation of metabolic and ventilatory variables and cardiac monitoring throughout the test.

Conditions

Eisenmenger Complex; Pulmonary Hypertension; Congenital Heart Defects

Outcome Measures

Primary Outcomes (2)

• Six minute walk test to measure functional capacity in eisenmenger syndrome

  Six minute walk test will be done with metabolic and ventilatory monitoring and Compared to the cardiopulmonary exercise testing variables , seeing your similarity and if this first test is applicable to measurement functional capacity in Eisenmenger syndrome

  One day

• Shuttle walk test to measure functional capacity in Eisenmenger syndrome

  Shuttle walk test will be done with metabolic and ventilatory monitoring and Compared to the cardiopulmonary exercise testing variables , seeing your similarity and if this first test is applicable to measurement functional capacity in Eisenmenger syndrome

  One day

Secondary Outcomes (7)

• Oxygen uptake kinetics during six minute walk test in Eisenmenger syndrome

  one day

• Correlation between Functional capacity evaluate with six minute walk test and respiratory function evaluate with manovacuometry, spirometry and muscular respiratory endurance.

  one day

• Correlation between Functional capacity evaluate with six minute walk test and peripheric muscular function, evaluate with quadriceps dynamometry and strength of handgrip

  one day

• Correlation between Functional capacity evaluate with six minute walk test and autonomic function, evaluate with cardiofrequency

  one day

• Correlation between Functional capacity evaluate with six minute walk test and life quality evaluate with SF-36 health survey questionnaire

  one day

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with eisenmenger syndrome that do ambulatory monitoring of congenital heart of Federal University of São Paulo.

You may qualify if:

• Diagnosis of Eisenmenger syndrome
• To understand the realization of tests
• That do ambulatory monitoring of congenital heart of Federal University of São Paulo..

You may not qualify if:

• Donw Syndrome
• Changing pace or lower limbs
• Neuromuscular disease
• Pulmonary Obstructive disease

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Universidade Federal de São Paulo

São Paulo, São Paulo, 04021-001, Brazil

RECRUITING

MeSH Terms

Conditions

Eisenmenger Complex; Hypertension, Pulmonary; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Study Officials

• Solange Guizilini, mastermind

  Federal University of São Paulo

  STUDY CHAIR

Central Study Contacts

Bruna CM Garcia, principal

CONTACT

+5512 981254979; brunacaroline_fisio@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 27, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: April 27, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)