Physical Capacity and Activity in Children With Congenital Heart Disease

NCT03275844 | Unknown DMC

• 1 other identifier: 2017-01
• Study Type: observational
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Defects, Congenital; Tetralogy of Fallot

Keywords

Physical activity; Physical capacity; Children

Outcome Measures

Primary Outcomes (1)

• Moderate-to-vigorous physical activity

  Time in minutes of Moderate-to-vigorous physical activity

  1 week

Secondary Outcomes (2)

• Six minute walking test

  1 hour

• Steps

  1 week

Study Arms (2)

Group 1

Children with congenital heart disease

Procedure: Physical activity assessment

Group 2

Control healthy subjects

Procedure: Physical activity assessment

Interventions

Physical activity assessment PROCEDURE

Assessment of Moderate-to-vigorous physical activity

Group 1; Group 2

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with congenital heart diseases

You may qualify if:

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

You may not qualify if:

• Morbid obesity
• Musculoskeletal disorders that impede physical activity
• Neurological comorbidity
• Respiratory comorbidity in the last 30 days.
• Pacemaker users

Sponsors & Collaborators

• Rodrigo Torres: lead

MeSH Terms

Conditions

Heart Defects, Congenital; Tetralogy of Fallot; Motor Activity

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Officials

• Homero Puppo, MSc

  Univeridad de Chile

  STUDY CHAIR

Central Study Contacts

Roberto M Acosta, MSc

CONTACT

56984123384; acostadighero@gmail.com

Rodrigo Torres, MSc

CONTACT

56992431383; klgorodrigotorres@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 8, 2017
• Study Start: November 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 8, 2017

Record last verified: 2017-09