Six Minutes Walk Test and Shuttle Walk Test in Eisenmenger Syndrome

Pulmonary Hypertension Clinical Trial

Official title:

Applicability of the Six Minutes Walk Test and Shuttle Walk Test and Evaluation of Peripheral and Respiratory Muscle Function, Autonomic Control, Quality of Life and Sleep, Inflammatory Markers and Tissue Perfusion in Eisenmenger Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02752399
• Other study ID #: 1.462.879
• Status: Recruiting
• Phase: N/A
• First received: April 18, 2016
• Last updated: April 22, 2016
• Start date: April 2016
• Est. completion date: June 2017

Study information

• Verified date: April 2016
• Source: Federal University of São Paulo
• Contact: Bruna CM Garcia, principal
• Phone: +5512 981254979
• Email: brunacaroline_fisio[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Description:

It has seen an increasing number of individuals with congenital heart diseases mainly due to the development of new diagnostic techniques, assessment and treatment, thereby contributing to longer survival. These individuals that survive to adulthood, many sometimes develop other secondary problems to the underlying pathology, one of Pulmonary Arterial Hypertension. The Syndrome Eisenmenger is the most advanced form of pulmonary hypertension secondary to congenital heart defects. It is known that patients with pulmonary hypertension secondary congenital heart disease have marked functional limitation and high risk of death. Among the various forms of assess exercise capacity, Walk Test Six Minutes (6MWT), Shuttle walking test and Cardiopulmonary Exercise Test are among the most applicable. Little has been studied about the patients with pulmonary hypertension secondary to congenital heart disease and Eisenmenger Syndrome. The characterization of this profile of patients against the effort becomes necessary and useful in determining strategies and identification of factors that may be limited to functional capacity and quality of life. Objectives: To verify the applicability Six minutes walk test and Shuttle walk test in assessing functional capacity in patients with Eisenmenger Syndrome. Methods: Cross-sectional study with patients diagnosed with Eisenmenger Syndrome, of both sexes, without changing pace or lower limbs, who have performed echocardiography in the last 6 months and clinical stability. 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. Also will be held assess respiratory endurance and strength, peripheral muscle strength and manual pinch, Heart rate variability, inflammatory mediators and blood lactate, besides questionnaires about quality of life, quality of sleep and daytime drowsiness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Eisenmenger syndrome

• To understand the realization of tests

• That do ambulatory monitoring of congenital heart of Federal University of São Paulo..

Exclusion Criteria:

• Donw Syndrome

• Changing pace or lower limbs

• Neuromuscular disease

• Pulmonary Obstructive disease

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Congenital Heart Defects
• Eisenmenger Complex
• Heart Defects, Congenital
• Hypertension, Pulmonary
• Pulmonary Hypertension

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Oxygen uptake kinetics during six minute walk test in Eisenmenger syndrome	Six minute walk test will be done with metabolic and ventilatory monitoring and we will go evaluate behavior of oxygen uptake kinetics in Eisenmenger Syndrome	one day	No
Secondary	Correlation between Functional capacity evaluate with six minute walk test and respiratory function evaluate with manovacuometry, spirometry and muscular respiratory endurance.		one day	No
Secondary	Correlation between Functional capacity evaluate with six minute walk test and peripheric muscular function, evaluate with quadriceps dynamometry and strength of handgrip		one day	No
Secondary	Correlation between Functional capacity evaluate with six minute walk test and autonomic function, evaluate with cardiofrequency		one day	No
Secondary	Correlation between Functional capacity evaluate with six minute walk test and life quality evaluate with SF-36 health survey questionnaire		one day	No
Secondary	Correlation between Functional capacity evaluate with six minute walk test and sleep quality, evaluate with pittsburgh questionnaire for sleep and Epworth Sleepiness Scale		one day	No
Secondary	Correlation between Functional capacity evaluate with six minute walk test and blood inflammatory mediators and blood lactate		one day	No