Skip to main content
Clinical Trials/NCT02752399
NCT02752399
Unknown
Not Applicable

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

Federal University of São Paulo1 site in 1 country60 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Eisenmenger Complex
Sponsor
Federal University of São Paulo
Enrollment
60
Locations
1
Primary Endpoint
Shuttle walk test to measure functional capacity in Eisenmenger syndrome
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
June 2017
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Federal University of São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Bruna Caroline Matos Garcia

Physiotherapist

Federal University of São Paulo

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

Outcomes

Primary Outcomes

Shuttle walk test to measure functional capacity in Eisenmenger syndrome

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)
  • 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)

Study Sites (1)

Loading locations...

Similar Trials