Physical Capacity and Activity in Children With Congenital Heart Disease

NCT ID: NCT03275844

Last Updated: 2017-09-08

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

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-09-01

Brief Summary

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Congenital malformations correspond to defects in organ morphogenesis identifiable at birth or intrauterine life, affecting 2-3% of births. Inside of these malformations, Congenital Heart Disease corresponds, in particular, to structural defects of the heart or major blood vessels thereof may or may not be associated with other types of syndromes.The resolution is usually surgical.

Also, these patients present a decrease in physical fitness, psychological imbalance, lower quality of life and risk significant morbidity and mortality from respiratory infections among other problems.

This can have severe consequences for health in the medium and long term. The habits acquired during childhood and adolescence are determinant for the adult life, being relevant levels of activity and physical condition, especially in children with pathologies.

In this way, it is vital to know from childhood parameters that indicate the baseline state of these patients according to the levels of physical activity, exercise capacity, nutritional status and quality of life. These will be key indicators to take into account in the future, to adapt rehabilitation plans that will reduce the effects of their condition.

The objective of this protocol is To characterize the levels of Activity, and Physical Capacity of children with congenital heart disease regularly treated at the Cardiovascular Center of Dr. Luis Hospital Calvo Mackenna, compared to healthy children matched by age and sex.

Detailed Description

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Conditions

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Heart Defects, Congenital Tetralogy of Fallot

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1

Children with congenital heart disease

Physical activity assessment

Intervention Type PROCEDURE

Assessment of Moderate-to-vigorous physical activity

Group 2

Control healthy subjects

Physical activity assessment

Intervention Type PROCEDURE

Assessment of Moderate-to-vigorous physical activity

Interventions

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Physical activity assessment

Assessment of Moderate-to-vigorous physical activity

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children with Tetralogy of Fallot corrected
* Age from 6 to 15 years
* Assistants to periodic control at HLCM Cardiovascular Center

Exclusion Criteria

* Morbid obesity
* Musculoskeletal disorders that impede physical activity
* Neurological comorbidity
* Respiratory comorbidity in the last 30 days.
* Pacemaker users
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rodrigo Torres

OTHER

Sponsor Role lead

Responsible Party

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Rodrigo Torres

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Homero Puppo, MSc

Role: STUDY_CHAIR

Univeridad de Chile

Central Contacts

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Roberto M Acosta, MSc

Role: CONTACT

56984123384

Rodrigo Torres, MSc

Role: CONTACT

56992431383

Other Identifiers

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2017-01

Identifier Type: -

Identifier Source: org_study_id

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