Clinical trial NCT06185140: Effects of Rehabilitation Programme on Respiratory Function in Patients with Acquired and Intervened Congenital Heart Disease.
Official title: Effects of Rehabilitation Programme on Respiratory Function in Patients with Acquired and Intervened Congenital Heart Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Defects, Congenital
Keywords: Exercise
Physiotherapy
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel randomized controlled trial with a simply assignment (1:1)
Primary purpose: TREATMENT

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 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.


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.

Primary outcomes:
measure: Assessment of respiratory function/spirometry
timeFrame: Baseline and immediately after the intervention
Secondary outcomes:
measure: Assessment of the respiratory musculature
timeFrame: Baseline and immediately after the intervention
measure: Functional capacity
timeFrame: Baseline and immediately after the intervention
Other outcomes:
Locations:
Study officials:
References: