Six Minutes Walk Test and Shuttle Walk Test in Eisenmenger Syndrome

• Conditions: Eisenmenger Complex; Congenital Heart Defects; Pulmonary Hypertension

• Registration Number: NCT02752399
• Lead Sponsor: Federal University of São Paulo

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.

Detailed 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.

Study Timeline

• Status Verified: 2016-04
• Study Start: 2016-04
• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-22
• Last Update Submitted: 2016-04-22
• Study First Posted: 2016-04-27
• Last Update Posted: 2016-04-27
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shuttle walk test to measure functional capacity in Eisenmenger syndrome	One day	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
Six minute walk test to measure functional capacity in eisenmenger syndrome	One day	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

Secondary Outcome Measures

Name	Time	Method
Correlation between Functional capacity evaluate with six minute walk test and life quality evaluate with SF-36 health survey questionnaire	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
Oxygen uptake kinetics during six minute walk test in Eisenmenger syndrome	one day	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
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 sleep quality, evaluate with pittsburgh questionnaire for sleep and Epworth Sleepiness Scale	one day
Correlation between Functional capacity evaluate with six minute walk test and blood inflammatory mediators and blood lactate	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

Trial Locations

Locations (1)

Universidade Federal de São Paulo; 🇧🇷 São Paulo, Brazil