Effects of Rehabilitation Programme on Respiratory Function in Patients with Acquired and Intervened Congenital Heart Disease.

University of Salamanca

Status: Not yet enrolling

Conditions: Heart Defects, Congenital

Treatments: Other: cardiac rehabilitation program; Other: TELEA platform

Study type: Interventional

Funder types: Other

Identifiers

NCT06185140

CardiorrespiUSAL

Details and patient eligibility

About

Congenital heart defects (CHDs) are heart malformations that occur before birth, and they represent one of the leading causes of neonatal morbidity and mortality. they occur in approximately 1% of newborns and are associated with high morbidity and mortality rates. The etiology of these cardiac anomalies is mostly unknown. around 70-80% of cases are generated by the involvement of multiple affected genes combined with an environmental trigger that, when acting on a susceptible individual, promotes the expression of the damaged genome. maternal diseases during pregnancy or exposure to teratogenic substances are also implicated in the etiology.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patients with a history of cardiac transplantation or acquired congenital heart disease who have undergone at least one interventional procedure or surgical intervention at least 6 months before the start of the program in a state of clinical stability, hemodynamic stability, and ECG stability. They should have residual hemodynamic defects of sufficient severity that potentially restrict participation, and their perception of fragility may be influenced by the social, family, school environment, or by the patient themselves.
• Children aged 6-15 years at the start of the study.
• Children with maximum predicted oxygen consumption (VO2 max) values <80%, as measured in ergospirometry 6 months before the start of the intervention program.
• Patients for whom consultation with a pediatric cardiology specialist and pediatric rehabilitation specialist has not revealed contraindications for exercise.
• Children and their legal representatives should have provided informed consent and the ability to travel to the hospital center for in-person intervention.

Exclusion criteria

• Patients with acute, inflammatory, or infectious health conditions that could pose a risk to them during the course of the program.
• Patients who have undergone at least one interventional procedure or surgical intervention within a period of less than 6 months before the start of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Intervention group

Experimental group

Description:

Cardiac rehabilitation program

Treatment:

Other: cardiac rehabilitation program

Control group

Active Comparator group

Description:

These patients will complete the program from their home through the TELEA platform that belongs to SERGAS. They go to the hospital once at the beginning of the program to learn the program with the Physiotherapist and once again after a month. The program will be carried out twice a week for their home. Patients will be monitored during physical exercise with Garmin® heart rate monitors. Patients will download heart rate and Borg scale data after each session and can establish contact through the TELEA platform with the nursing staff of the Cardiac RHB Unit at all times.

Treatment:

Other: TELEA platform