Physical Rehabilitation in Patients With Complex Congenital Heart Disease (Rehabkids)

July 21, 2025 updated by: Hospital do Coracao

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04004-030
        • Hospital do Coracao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Physical Rehabilitation
Physical Rehabilitation in 36 sessions
Other: Physical rehabilitation
Physical Rehabilitation in 36 sessions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
In 36 physical rehabilitation sessions, twice a week lasting about 4.5 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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
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.

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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital do Coracao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025physicalrehab
  • CAAE 22130219.0.0000.0060 (Other Identifier: CEP - FMUSP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

If any researcher is interested in replicating the study, please contact us for further clarification.

IPD Sharing Time Frame

If any researcher is interested in replicating the study, please contact us for further clarification.

IPD Sharing Access Criteria

If any researcher is interested in replicating the study, please contact us for further clarification.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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