Physical Capacity and Activity in Children With Congenital Heart Disease

• Conditions: Heart Defects, Congenital; Tetralogy of Fallot
• Interventions: Procedure: Physical activity assessment

• Registration Number: NCT03275844
• Lead Sponsor: Rodrigo Torres

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2017-09
• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-05
• Last Update Submitted: 2017-09-05
• Study First Posted: 2017-09-08
• Last Update Posted: 2017-09-08
• Study Start: 2017-11-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Physical activity assessment	Children with congenital heart disease
Group 2	Physical activity assessment	Control healthy subjects

Primary Outcome Measures

Name	Time	Method
Moderate-to-vigorous physical activity	1 week	Time in minutes of Moderate-to-vigorous physical activity

Secondary Outcome Measures

Name	Time	Method
Six minute walking test	1 hour	Walked distance in six minute walking test
Steps	1 week	mean of number of steps per day