Working... Menu

Physical Capacity and Activity in Children With Congenital Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03275844
Recruitment Status : Not yet recruiting
First Posted : September 8, 2017
Last Update Posted : September 8, 2017
Information provided by (Responsible Party):
Rodrigo Torres, University of Chile

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.

Condition or disease Intervention/treatment
Heart Defects, Congenital Tetralogy of Fallot Procedure: Physical activity assessment

Layout table for study information
Study Type : Observational
Estimated Enrollment : 17 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Physical Capacity and Activity in Children With Congenital Heart Disease in Chile
Estimated Study Start Date : November 1, 2017
Estimated Primary Completion Date : March 1, 2018
Estimated Study Completion Date : September 1, 2018

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

Primary Outcome Measures :
  1. Moderate-to-vigorous physical activity [ Time Frame: 1 week ]
    Time in minutes of Moderate-to-vigorous physical activity

Secondary Outcome Measures :
  1. Six minute walking test [ Time Frame: 1 hour ]
    Walked distance in six minute walking test

  2. Steps [ Time Frame: 1 week ]
    mean of number of steps per day

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children with congenital heart diseases

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03275844

Layout table for location contacts
Contact: Roberto M Acosta, MSc 56984123384
Contact: Rodrigo Torres, MSc 56992431383

Sponsors and Collaborators
Rodrigo Torres
Layout table for investigator information
Study Chair: Homero Puppo, MSc Univeridad de Chile

Layout table for additonal information
Responsible Party: Rodrigo Torres, Assistant Professor, University of Chile Identifier: NCT03275844     History of Changes
Other Study ID Numbers: 2017-01
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Probably, All information will be public

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rodrigo Torres, University of Chile:
Physical activity
Physical capacity

Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Heart Defects, Congenital
Congenital Abnormalities
Tetralogy of Fallot
Cardiovascular Diseases
Cardiovascular Abnormalities