Heart Defects, CongenitalNCT03275844
Physical Capacity and Activity in Children With Congenital Heart Disease
An observational study of Heart Defects, Congenital and Tetralogy of Fallot, run by Rodrigo Torres.
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… Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Defects, Congenital, Tetralogy of Fallot
- What is being tested?
- Physical activity assessment
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 1 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with congenital heart diseases
Who may be able to join
- Children with Tetralogy of Fallot corrected
- Age from 6 to 15 years
- Assistants to periodic control at HLCM Cardiovascular Center
Who cannot join
- Morbid obesity
- Musculoskeletal disorders that impede physical activity
- Neurological comorbidity
- Respiratory comorbidity in the last 30 days.
- Pacemaker users
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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
- Being tested
- Physical activity assessment
- Keywords
- Physical activity, Physical capacity, Children
- Medical subject headings
- Heart Defects, Congenital, Tetralogy of Fallot, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity assessmentProcedure or surgery
Assessment of Moderate-to-vigorous physical activity
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Children with congenital heart disease Receives: Procedure: Physical activity assessment | |
| Group 2 | Control healthy subjects Receives: Procedure: Physical activity assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate-to-vigorous physical activity
Time in minutes of Moderate-to-vigorous physical activity
Measured: 1 week
Secondary outcomes (2)
Six minute walking test
Walked distance in six minute walking test
Measured: 1 hour
Steps
mean of number of steps per day
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Mar 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rodrigo Torres
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rodrigo Torres, University of Chile
- Investigators
- Homero Puppo, MSc, Study chair, Univeridad de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275844
- Sponsor's protocol ID
- 2017-01
- Status last verified
- Sep 2017
- First submitted
- 5 Sep 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Probably, All information will be public
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Capacity and Activity in Children With Congenital Heart Disease in Chile
- ClinicalTrials.gov ID
- NCT03275844
- Acronym / sponsor ID
- 2017-01
- Conditions
- Heart Defects, Congenital, Tetralogy of Fallot
- Keywords
- Physical activity, Physical capacity, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Rodrigo TorresUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Physical activity assessmentChildren with congenital heart disease |
| Group 2 | – | Procedure: Physical activity assessmentControl healthy subjects |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with congenital heart diseases
Key inclusion criteria (3 listed)
- Children with Tetralogy of Fallot corrected
- Age from 6 to 15 years
- Assistants to periodic control at HLCM Cardiovascular Center
Key exclusion criteria (5 listed)
- Morbid obesity
- Musculoskeletal disorders that impede physical activity
- Neurological comorbidity
- Respiratory comorbidity in the last 30 days.
- Pacemaker users
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity assessmentAssessment of Moderate-to-vigorous physical activity | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Moderate-to-vigorous physical activity
Time frame: 1 week
Time in minutes of Moderate-to-vigorous physical activity
2 secondary outcomes
Six minute walking test
Time frame: 1 hour
Steps
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Individual participant dataSharing planned: Undecided. Probably, All information will be public
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Homero Puppo, MSc study chair
Univeridad de Chile
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Defects, Congenital and Tetralogy of Fallot, run by Rodrigo Torres.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto M Acosta, MSc (56984123384, acostadighero@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate-to-vigorous physical activity (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2017; AzTrials last refreshed its copy on 7 Nov 2026.