Physical Rehabilitation in Patients With Complex Congenital Heart Disease

NCT ID: NCT07089264

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2025-12-31

Brief 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. 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.

Conditions

Congenital Heart Disease (CHD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical Rehabilitation

Physical Rehabilitation in 36 sessions

Group Type: OTHER

Physical rehabilitation

Intervention Type: OTHER

Physical Rehabilitation in 36 sessions

Interventions

Physical rehabilitation

Physical Rehabilitation in 36 sessions

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital do Coracao

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital do Coração

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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. 2024 Oct 21. doi: 10.1007/s00246-024-03666-8. Online ahead of print.

Reference Type: BACKGROUND

PMID: 39432096 (View on PubMed)

Other Identifiers

CAAE 22130219.0.0000.0060

Identifier Type: OTHER

Identifier Source: secondary_id

2025physicalrehab

Identifier Type: -

Identifier Source: org_study_id