Six Minutes Walk Test and Shuttle Walk Test in Eisenmenger Syndrome

NCT ID: NCT02752399

Last Updated: 2016-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Eisenmenger Complex Pulmonary Hypertension Congenital Heart Defects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Bruna Caroline Matos Garcia

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Solange Guizilini, mastermind

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

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Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Bruna CM Garcia, principal

Role: CONTACT

+5512 981254979

Facility Contacts

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Bruna C Matos Garcia

Role: primary

(+5512) 981254979

Other Identifiers

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1.462.879

Identifier Type: -

Identifier Source: org_study_id

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