Congenital Heart Disease (CHD)RehabkidsNCT07089264
Physical Rehabilitation in Patients With Complex Congenital Heart Disease
A study testing Physical rehabilitation in people with Congenital Heart Disease (CHD), run by Hospital do Coracao at 1 site in Brazil.
Trial summary
Studies have shown that patients with congenital heart disease have functional changes compared to healthy individuals. Several interventions can be performed to minimize these changes; physical rehabilitation is one of these possible treatments that can generate numerous benefits for patients. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Congenital Heart Disease (CHD)
- What is being tested?
- Physical rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2019to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- no previous or current history of other non-cardiological disease
- patients undergoing complex congenital heart surgeries with a minimum postoperative period of 1 year
- clinically stable; with no complex arrhythmia(s) in the last electrocardiogram or clinical evaluation
- with medical monitoring
- clinical clearance to carry out the protocols
- consent with the Free and Informed Consent Form (FICF) and Assent Form signed by the guardian and the patient respectively.
Who cannot join
- patients with musculoskeletal or neuropsychiatric alterations without the possibility of performing a functional test (ergospirometry test),
- hemodynamically unstable patients
- severe respiratory or metabolic conditions
- patients residing in regions far from São Paulo,
- patients which make frequent visits to the institution unfeasible
- patients who do not attend the rehabilitation program or those for whom it was not possible to maintain and update registration data.
Trial locations and contacts
1 site in 1 country.
About this study
Studies have shown that patients with congenital heart disease have functional changes compared to healthy individuals. Several interventions can be performed to minimize these changes; physical rehabilitation is one of these possible treatments that can generate numerous benefits for patients. The aim of this study is to evaluate the response to physical rehabilitation in patients after surgical correction of congenital heart disease.
Methods This cross-sectional study included patients with complex congenital heart disease who underwent surgical correction. Different examinations were performed: cardiopulmonary exercise was used; and the six-minute walk test was used to determine functional capacity, the quality of life cardiac version questionnaire was used to determine quality of life. Descriptive analysis of patients was performed for all the data.
Read the detailed description
Study design and population This cross-sectional study analyzed those patients with complex congenital heart disease who underwent surgical correction at Hospital do Coração, São Paulo - Brazil. The institutional ethics committees on human research approved . All the subjects signed consent forms before starting the protocol.
The survey of patients eligible for the physical rehabilitation protocol was conducted at the Congenital Cardiology Outpatient Clinic of the Hospital do Coração. Patients currently under clinical follow-up the investigators selected for inclusion in the study. The protocol was presented to the medical team, and patients who did not exhibit neuromuscular, pulmonary, or complex orthopedic conditions that could interfere with the performance of the assessments the investigators chosen.
Transthoracic echocardiography The transthoracic echocardiographic evaluation will be performed using the two-dimensional technique, always by an echocardiographer. All images will be obtained by software, using an appropriate transducer. Echocardiographic measurements will be made in accordance with the recommendations of the congenital heart disease consensus.
Cardiopulmonary exercise test The cardiopulmonary exercise test was performed using a treadmill exercise test equipped with a metabolic analyzer. This assessment aimed to determine the subject's maximal cardiopulmonary capacity.
Blood pressure measurements were taken at rest, every two minutes during exercise, and every minute during the recovery phase. All readings were taken by the same observer, using the auscultatory method to ensure consistency.
A customized ramp-up protocol based on the modified Balke approach was employed, featuring an increase in speed during the first 3 minutes, followed by a two percent rise increase in incline every minute until the participant reached exhaustion.
Ventilation, oxygen consumption, and carbon dioxide production were assessed using a breath-by-breath analysis technique, from which ventilatory thresholds were calculated. Maximal functional capacity was determined using absolute peak oxygen and relative peak oxygen, expressed as a percentage of predicted values for age- and sex-matched healthy individuals.
Additional parameters, including the oxygen uptake efficiency slope and the ventilatory equivalent for carbon dioxide, were also measured and analyzed.
Six-minute walk test A submaximal analysis of physical capacity was conducted using the six-minute walk test, following the protocol.
The patients were instructed to walk as quickly as possible without running for six minutes, while the distance covered was recorded. Breaks during the walk were allowed if needed. The data analyzed included the distance covered in meters, heart rate, respiratory rate, peripheral oxygen saturation, blood pressure, and the fatigue. These measurements were taken at rest one minute before the test, immediately after the test, two minutes after the test if there was an interruption, and five minutes after the test.
Quality of life To evaluate quality of life, the investigators employed the Pediatric Quality of Life Inventory cardiac version questionnaire. This instrument encompasses various domains, including symptoms, treatment, physical appearance, anxiety related to treatment, challenges with understanding and communication. The questionnaire is completed by both the patient and their parents.
- Conditions
- Congenital Heart Disease (CHD)
- Being tested
- Physical rehabilitation
- Keywords
- congenital heart disease, quality of life, cardiopulmonary, six-minute walk test, physical rehabilitation
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical rehabilitationOther
Physical Rehabilitation in 36 sessions
| Study group | Role | What they receive |
|---|---|---|
| Physical Rehabilitation | Other | Physical Rehabilitation in 36 sessions Receives: Other: Physical rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the response to aerobic activity and peripheral muscle strength training in children with congenital heart disease.
Quantify the speed (which is the measurement of distance in kilometers divided by time in hours) of walking and running in km/h during aerobic exercises on a treadmill; evaluate the load capacity in kilograms in lower and upper limb exercises.
Measured: In 36 physical rehabilitation sessions, twice a week lasting about 4.5 weeks
Secondary outcomes (4)
Quality of life assessment
To assess quality of life, we used the Pediatric Quality of Life Inventory (PedsQL) questionnaire, cardiac version. This instrument covers several domains such as: symptoms, treatment, physical appearance, anxiety related to treatment and difficulties in understanding and communication. The questionnaire is completed by both the patient and their parents. These questions are presented in which the highest score (100) represents the best quality of life and the lowest score (0) represents the worst quality of life.
Measured: The test lasts approximately 10 minutes and will be performed on day 1 of care and on the last day - day 36.
The cardiopulmonary test - ergospirometry
The test was performed using an individualized ramp protocol on a treadmill, monitored by 12-lead electrocardiogram, heart rate in beats per minute (bpm), and blood pressure in millimeters of mercury (mmHg) using the digital method. The metabolic analyzer and exhaled gas collection during the rest, exercise, and recovery phases were performed using a mask connected to a gas analysis system, calibrated before each test. Direct measurements of minute ventilation in liters (L), peak oxygen consumption in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min), and carbon dioxide output as the partial pressure of carbon dioxide (PaCO2) were performed.
Measured: The test lasts approximately 30 minutes and will be performed on the first day - day 1 of care and on the last day - day 36 of care for discharge.
Submaximal exercise test - six-minute walk test
A submaximal analysis of physical capacity was conducted using the six-minute walk test (6MWT), following the protocol of the American Thoracic Society. The patients were instructed to walk as quickly as possible without running for six minutes, while the distance covered was recorded. Breaks during the walk were allowed if needed. The data analyzed included the distance covered in meters, heart rate, respiratory rate, peripheral oxygen saturation, blood pressure, and the Modified Borg Scale for Fatigue. These measurements were taken at rest one minute before the test, immediately after the test, two minutes after the test if there was an interruption, and five minutes after the test
Measured: The test lasts approximately 10 minutes and will be performed on day 1 of care and on the last day - day 36.
Assessment of cardiac function
Transthoracic echocardiographic assessment will be performed using the two-dimensional technique. Echocardiographic measurements will be made in accordance with the recommendations of the American Society of Echocardiography and the Congenital Heart Disease Consensus.
The assessment of atrioventricular valve function will be made based on the degree of stenosis through analysis of the mean diastolic gradient measured in millimeters of mercury (mmHg) and the assessment of the degree of regurgitation through color Doppler to identify the direction and extent of reverse blood flow. The severity of regurgitation can be classified as mild, moderate or severe.
Measured: The test lasts approximately 30 minutes and will be performed on the first day - day 1 of care and on the last day - day 36 of care for discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Sep 2019
- Primary completion15 Jan 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart Disease (CHD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This cross-sectional study included 15 children with complex congenital heart disease who underwent surgical correction. Different examinations were performed: cardiopulmonary exercise was used; and the six-minute walk test (6MWT) was used to determine functional capacity, the Peds - QL cardiac version questionnaire was used to determine quality of life. Descriptive analysis of patients was performed for all the data.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089264
- Sponsor's protocol ID
- 2025physicalrehab
- Other IDs
- CAAE 22130219.0.0000.0060
- Acronym
- Rehabkids
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If any researcher is interested in replicating the study, please contact us for further clarification.
Publications
Silveira JBPDM, Turquetto ALR, Amato LP, Agostinho DR, Caneo LF, Binotto MA, da Costa Soares Lopes MI, Rodrigues JC, Santos MVB, Oliveira PA, TanaKa ACS, Jatene MB. Comparative Analysis of Respiratory and Functional Outcomes in Children Post-Fontan Procedure Versus Healthy Peers. Pediatr Cardiol. 2025 Dec;46(8):2379-2390. doi: 10.1007/s00246-024-03666-8. Epub 2024 Oct 21.
PubMed 39432096
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Rehabilitation in Patients With Complex Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT07089264
- Acronym / sponsor ID
- Rehabkids / 2025physicalrehab
- Conditions
- Congenital Heart Disease (CHD)
- Keywords
- congenital heart disease, quality of life, cardiopulmonary, six-minute walk test, physical rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Jul 2025 (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.
Studies have shown that patients with congenital heart disease have functional changes compared to healthy individuals. Several interventions can be performed to minimize these changes; physical rehabilitation is one of these possible treatments that can generate numerous benefits for patients. The aim of this study is to evaluate the response to physical rehabilitation in patients after surgical correction of congenital heart disease.
Methods This cross-sectional study included patients with complex congenital heart disease who underwent surgical correction. Different examinations were performed: cardiopulmonary exercise was used; and the six-minute walk test was used to determine functional capacity, the quality of life cardiac version questionnaire was used to determine quality of life. Descriptive analysis of patients was performed for all the data.
Detailed description
Study design and population This cross-sectional study analyzed those patients with complex congenital heart disease who underwent surgical correction at Hospital do Coração, São Paulo - Brazil. The institutional ethics committees on human research approved . All the subjects signed consent forms before starting the protocol.
The survey of patients eligible for the physical rehabilitation protocol was conducted at the Congenital Cardiology Outpatient Clinic of the Hospital do Coração. Patients currently under clinical follow-up the investigators selected for inclusion in the study. The protocol was presented to the medical team, and patients who did not exhibit neuromuscular, pulmonary, or complex orthopedic conditions that could interfere with the performance of the assessments the investigators chosen.
Transthoracic echocardiography The transthoracic echocardiographic evaluation will be performed using the two-dimensional technique, always by an echocardiographer. All images will be obtained by software, using an appropriate transducer. Echocardiographic measurements will be made in accordance with the recommendations of the congenital heart disease consensus.
Cardiopulmonary exercise test The cardiopulmonary exercise test was performed using a treadmill exercise test equipped with a metabolic analyzer. This assessment aimed to determine the subject's maximal cardiopulmonary capacity.
Blood pressure measurements were taken at rest, every two minutes during exercise, and every minute during the recovery phase. All readings were taken by the same observer, using the auscultatory method to ensure consistency.
A customized ramp-up protocol based on the modified Balke approach was employed, featuring an increase in speed during the first 3 minutes, followed by a two percent rise increase in incline every minute until the participant reached exhaustion.
Ventilation, oxygen consumption, and carbon dioxide production were assessed using a breath-by-breath analysis technique, from which ventilatory thresholds were calculated. Maximal functional capacity was determined using absolute peak oxygen and relative peak oxygen, expressed as a percentage of predicted values for age- and sex-matched healthy individuals.
Additional parameters, including the oxygen uptake efficiency slope and the ventilatory equivalent for carbon dioxide, were also measured and analyzed.
Six-minute walk test A submaximal analysis of physical capacity was conducted using the six-minute walk test, following the protocol.
The patients were instructed to walk as quickly as possible without running for six minutes, while the distance covered was recorded. Breaks during the walk were allowed if needed. The data analyzed included the distance covered in meters, heart rate, respiratory rate, peripheral oxygen saturation, blood pressure, and the fatigue. These measurements were taken at rest one minute before the test, immediately after the test, two minutes after the test if there was an interruption, and five minutes after the test.
Quality of life To evaluate quality of life, the investigators employed the Pediatric Quality of Life Inventory cardiac version questionnaire. This instrument encompasses various domains, including symptoms, treatment, physical appearance, anxiety related to treatment, challenges with understanding and communication. The questionnaire is completed by both the patient and their parents.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This cross-sectional study included 15 children with complex congenital heart disease who underwent surgical correction. Different examinations were performed: cardiopulmonary exercise was used; and the six-minute walk test (6MWT) was used to determine functional capacity, the Peds - QL cardiac version questionnaire was used to determine quality of life. Descriptive analysis of patients was performed for all the data.
| Arm | Type | Receives |
|---|---|---|
| Physical Rehabilitation | Other | Other: Physical rehabilitationPhysical Rehabilitation in 36 sessions |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- no previous or current history of other non-cardiological disease
- patients undergoing complex congenital heart surgeries with a minimum postoperative period of 1 year
- clinically stable; with no complex arrhythmia(s) in the last electrocardiogram or clinical evaluation
- with medical monitoring
- clinical clearance to carry out the protocols
Key exclusion criteria (6 listed)
- patients with musculoskeletal or neuropsychiatric alterations without the possibility of performing a functional test (ergospirometry test),
- hemodynamically unstable patients
- severe respiratory or metabolic conditions
- patients residing in regions far from São Paulo,
- patients which make frequent visits to the institution unfeasible
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 rehabilitationPhysical Rehabilitation in 36 sessions | Other | Physical Rehabilitation |
Primary outcome
Evaluate the response to aerobic activity and peripheral muscle strength training in children with congenital heart disease.
Time frame: In 36 physical rehabilitation sessions, twice a week lasting about 4.5 weeks
Quantify the speed (which is the measurement of distance in kilometers divided by time in hours) of walking and running in km/h during aerobic exercises on a treadmill; evaluate the load capacity in kilograms in lower and upper limb exercises.
4 secondary outcomes
Quality of life assessment
Time frame: The test lasts approximately 10 minutes and will be performed on day 1 of care and on the last day - day 36.
The cardiopulmonary test - ergospirometry
Time frame: The test lasts approximately 30 minutes and will be performed on the first day - day 1 of care and on the last day - day 36 of care for discharge.
Submaximal exercise test - six-minute walk test
Time frame: The test lasts approximately 10 minutes and will be performed on day 1 of care and on the last day - day 36.
Assessment of cardiac function
Time frame: The test lasts approximately 30 minutes and will be performed on the first day - day 1 of care and on the last day - day 36 of care for discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Background: PubMed 39432096Silveira JBPDM, Turquetto ALR, Amato LP, Agostinho DR, Caneo LF, Binotto MA, da Costa Soares Lopes MI, Rodrigues JC, Santos MVB, Oliveira PA, TanaKa ACS, Jatene MB. Comparative Analysis of Respiratory and Functional Outcomes in Children Post-Fontan Procedure Versus Healthy Peers. Pediatr Cardiol. 2025 Dec;46(8):2379-2390. doi: 10.1007/s00246-024-03666-8. Epub 2024 Oct 21.
- Individual participant dataSharing planned: Yes. If any researcher is interested in replicating the study, please contact us for further clarification.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical rehabilitation in people with Congenital Heart Disease (CHD), run by Hospital do Coracao at 1 site in Brazil.
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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the response to aerobic activity and peripheral muscle strength training in children with congenital heart disease. (time frame: In 36 physical rehabilitation sessions, twice a week lasting about 4.5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07089264, which also lists 1 linked publication.
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 28 Jul 2025.