Status:
NOT_YET_RECRUITING
Effects of Rehabilitation Programme on Respiratory Function in Patients with Acquired and Intervened Congenital Heart Disease.
Lead Sponsor:
University of Salamanca
Conditions:
Heart Defects, Congenital
Eligibility:
All Genders
18-25 years
Phase:
NA
Brief Summary
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 new...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06185140
Start Date
January 1 2025
End Date
December 31 2025
Last Update
December 6 2024
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