Effects of Rehabilitation Programme on Respiratory Function in Patients with Acquired and Intervened Congenital Heart Disease.
Launched by UNIVERSITY OF SALAMANCA · Dec 14, 2023
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how a special rehabilitation program can help improve breathing and overall health in children who have congenital heart defects (CHDs) or have had heart transplants. CHDs are heart problems that babies are born with, and they can lead to serious health issues. The study aims to see if the rehabilitation program can help these young patients who have had surgery or other treatments in the past and still have some heart-related challenges.
To participate in the trial, children aged 6 to 15 years who have had certain heart procedures at least six months ago may be eligible. They need to be stable in their heart health and show some limitations in their ability to exercise. Before joining, their doctors will ensure it's safe for them to participate. Participants can expect to take part in a structured rehabilitation program designed to help them strengthen their lungs and heart. It’s important to note that children with infections or recent surgeries won't be able to join the study. Overall, this trial hopes to find new ways to support children with heart conditions in living healthier lives.
Gender
ALL
Eligibility criteria
- 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.
About University Of Salamanca
The University of Salamanca, one of the oldest and most prestigious universities in Spain, is a leading institution in academic research and clinical trials. With a strong commitment to advancing healthcare and medical science, the university engages in innovative research initiatives that address critical health challenges. Its clinical trial programs are characterized by rigorous scientific methodology, interdisciplinary collaboration, and a focus on ethical standards, ensuring high-quality outcomes that contribute to the advancement of medical knowledge and patient care. The University of Salamanca fosters partnerships with healthcare professionals and industry leaders, positioning itself at the forefront of clinical research and education.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported