ClinicalTrials.gg
Status unknownNCT03275844Updated Sep 8, 2017

Physical Capacity and Activity in Children With Congenital Heart Disease

An observational study in Heart Defects, Congenital and Tetralogy of Fallot, sponsored by Rodrigo Torres. Status unknown. Open to participants aged 6 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-08.

Primary conditionTetralogy of FallotRegistry: Heart Defects, CongenitalReclassifiedWhy we changed it
Registry
Heart Defects, Congenital — the first condition term the registry derived for this study.
ClinicalTrials.gg
Tetralogy of Fallot
Why
  1. The study's listed conditions name Tetralogy of Fallot, a narrower term within Heart Defects, Congenital.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Rodrigo Torres · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
17
Ages
6 Years to 15 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Defects, Congenital
  • Tetralogy of Fallot

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Keywords

  • Physical activity
  • Physical capacity
  • Children
03

In context

Tetralogy of Fallot Reclassified

92 studies on the registry are indexed under Tetralogy of Fallot; 25 are open to participants now.

This study's planned enrollment of 17 is below the median of 150 across 40 observational studies indexed under Tetralogy of Fallot.

Browse Tetralogy of Fallot studies →

Lead sponsor

This is the only study on the registry with Rodrigo Torres as lead sponsor.

Compared within Tetralogy of Fallot, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Defects, Congenital. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
6 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children with congenital heart diseases

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Morbid obesity
  • Musculoskeletal disorders that impede physical activity
  • Neurological comorbidity
  • Respiratory comorbidity in the last 30 days.
  • Pacemaker users
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
17 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group 1

    Children with congenital heart disease

    Procedure: Physical activity assessment

  • Group 2

    Control healthy subjects

    Procedure: Physical activity assessment

Interventions

  • ProcedurePhysical activity assessment

    Assessment of Moderate-to-vigorous physical activity

06

What researchers measure

Primary outcomes

  1. Moderate-to-vigorous physical activity

    Time in minutes of Moderate-to-vigorous physical activity

    Time frame: 1 week

Secondary outcomes

  1. Six minute walking test

    Walked distance in six minute walking test

    Time frame: 1 hour

  2. Steps

    mean of number of steps per day

    Time frame: 1 week

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — Probably, All information will be public

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2017; primary completion for Mar 2018, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2017
First posted
Sep 8, 2017
StartEst.
Nov 1, 2017
Primary completionEst.
Mar 1, 2018
CompletionEst.
Sep 1, 2018
Last update
Sep 8, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03275844
Lead sponsor
Rodrigo Torres
Responsible party
Rodrigo Torres (Assistant Professor, University of Chile) — Sponsor-investigator
First posted
Sep 8, 2017
Start date
Nov 1, 2017 (estimated)
Primary completion
Mar 1, 2018 (estimated)
Completion
Sep 1, 2018 (estimated)
Last update
Sep 8, 2017

Study contacts

Roberto M Acosta, MSc
Contact
acostadighero@gmail.com
56984123384
Rodrigo Torres, MSc
Contact
klgorodrigotorres@gmail.com
56992431383
Homero Puppo, MSc
study chair · Univeridad de Chile

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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