Physical Capacity and Activity in Children With Congenital Heart Disease

Heart Defects, Congenital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03275844
• Other study ID #: 2017-01
• Status: Not yet recruiting
• Phase: N/A
• First received: September 5, 2017
• Last updated: September 5, 2017
• Start date: November 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: September 2017
• Source: University of Chile
• Contact: Roberto M Acosta, MSc
• Phone: 56984123384
• Email: acostadighero[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 17
• Est. completion date: September 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital
• Heart Diseases
• Tetralogy of Fallot

Intervention

Procedure:
• Physical activity assessment
Assessment of Moderate-to-vigorous physical activity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rodrigo Torres

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderate-to-vigorous physical activity	Time in minutes of Moderate-to-vigorous physical activity	1 week
Secondary	Six minute walking test	Walked distance in six minute walking test	1 hour
Secondary	Steps	mean of number of steps per day	1 week