Physical Capacity and Activity in Children With Congenital Heart Disease

Physical Capacity and Activity in Children With Congenital Heart Disease in Chile

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.

Study Overview

• Status: Unknown
• Conditions: Heart Defects, Congenital; Tetralogy of Fallot
• Intervention / Treatment: Procedure: Physical activity assessment

• Study Type: Observational
• Enrollment (Anticipated): 17

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with congenital heart diseases

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Children with congenital heart disease	Procedure: Physical activity assessment; Assessment of Moderate-to-vigorous physical activity
Group 2; Control healthy subjects	Procedure: Physical activity assessment; Assessment of Moderate-to-vigorous physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate-to-vigorous physical activity	Time in minutes of Moderate-to-vigorous physical activity	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six minute walking test	Walked distance in six minute walking test	1 hour
Steps	mean of number of steps per day	1 week

Collaborators and Investigators

• Sponsor: Rodrigo Torres
• Investigators: Study Chair: Homero Puppo, MSc, Univeridad de Chile

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 8, 2017
• Last Update Submitted That Met QC Criteria: September 5, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Children; Physical activity; Physical capacity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Tetralogy of Fallot; Heart Defects, Congenital
• Other Study ID Numbers: 2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Probably, All information will be public

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No