Physical Rehabilitation in Patients With Complex Congenital Heart Disease

NCT07089264 | Active Not Recruiting DMC

• 2 other identifiers: 2025physicalrehabCAAE 22130219.0.0000.0060
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease (CHD)

Keywords

congenital heart disease; quality of life; cardiopulmonary; six-minute walk test; physical rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  In 36 physical rehabilitation sessions, twice a week lasting about 4.5 weeks

Secondary Outcomes (4)

• Quality of life assessment

  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 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

  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

  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.

Study Arms (1)

Physical Rehabilitation

OTHER

Physical Rehabilitation in 36 sessions

Other: Physical rehabilitation

Interventions

Physical rehabilitation OTHER

Physical Rehabilitation in 36 sessions

Physical Rehabilitation

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital do Coracao: lead

Study Sites (1)

Hospital do Coração

São Paulo, São Paulo, 04004-030, Brazil

Location

Related Publications (1)

• 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.

  PMID: 39432096 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: July 28, 2025
• Study Start: September 1, 2019
• Primary Completion: January 15, 2025
• Study Completion: December 31, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: If any researcher is interested in replicating the study, please contact us for further clarification.
• Access Criteria: If any researcher is interested in replicating the study, please contact us for further clarification.

Locations

BR (1)