Skip to content

Six Minutes Walk Test and Shuttle Walk Test in Eisenmenger Syndrome

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02752399
Enrollment
60
Registered
2016-04-27
Start date
2016-04-30
Completion date
2017-06-30
Last updated
2016-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Defects, Eisenmenger Complex, Pulmonary Hypertension

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.

Interventions

None listed

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Six minute walk test to measure functional capacity in eisenmenger syndromeOne daySix 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
Shuttle walk test to measure functional capacity in Eisenmenger syndromeOne dayShuttle 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

MeasureTime frameDescription
Correlation between Functional capacity evaluate with six minute walk test and respiratory function evaluate with manovacuometry, spirometry and muscular respiratory endurance.one day
Correlation between Functional capacity evaluate with six minute walk test and peripheric muscular function, evaluate with quadriceps dynamometry and strength of handgripone day
Correlation between Functional capacity evaluate with six minute walk test and life quality evaluate with SF-36 health survey questionnaireone day
Correlation between Functional capacity evaluate with six minute walk test and sleep quality, evaluate with pittsburgh questionnaire for sleep and Epworth Sleepiness Scaleone day
Correlation between Functional capacity evaluate with six minute walk test and blood inflammatory mediators and blood lactateone day
Correlation between Functional capacity evaluate with six minute walk test and autonomic function, evaluate with cardiofrequencyone day
Oxygen uptake kinetics during six minute walk test in Eisenmenger syndromeone daySix minute walk test will be done with metabolic and ventilatory monitoring and we will go evaluate behavior of oxygen uptake kinetics in Eisenmenger Syndrome

Countries

Brazil

Contacts

Primary ContactBruna CM Garcia, principal
brunacaroline_fisio@hotmail.com+5512 981254979

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026