Clinical trial NCT02752399: Six Minutes Walk Test and Shuttle Walk Test in Eisenmenger Syndrome
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eisenmenger Complex
Pulmonary Hypertension
Congenital Heart Defects
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with eisenmenger syndrome that do ambulatory monitoring of congenital heart of 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.

Eligibility criteria: 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

Primary outcomes:
measure: Six minute walk test to measure functional capacity in eisenmenger syndrome
timeFrame: One day
measure: Shuttle walk test to measure functional capacity in Eisenmenger syndrome
timeFrame: One day
Secondary outcomes:
measure: Oxygen uptake kinetics during six minute walk test in Eisenmenger syndrome
timeFrame: one day
measure: Correlation between Functional capacity evaluate with six minute walk test and respiratory function evaluate with manovacuometry, spirometry and muscular respiratory endurance.
timeFrame: one day
measure: Correlation between Functional capacity evaluate with six minute walk test and peripheric muscular function, evaluate with quadriceps dynamometry and strength of handgrip
timeFrame: one day
measure: Correlation between Functional capacity evaluate with six minute walk test and autonomic function, evaluate with cardiofrequency
timeFrame: one day
measure: Correlation between Functional capacity evaluate with six minute walk test and life quality evaluate with SF-36 health survey questionnaire
timeFrame: one day
measure: Correlation between Functional capacity evaluate with six minute walk test and sleep quality, evaluate with pittsburgh questionnaire for sleep and Epworth Sleepiness Scale
timeFrame: one day
measure: Correlation between Functional capacity evaluate with six minute walk test and blood inflammatory mediators and blood lactate
timeFrame: one day
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Solange Guizilini, mastermind
role: STUDY_CHAIR
References: