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Not yet recruiting NCT06185140

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

No phase Interventional Heart Defects, Congenital

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cardiac rehabilitation program, TELEA platform.
Who it may be relevant to
Registry conditions: Heart Defects, Congenital. Basic parameters: 18 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of Rehabilitation Programme on Respiratory Function in Patients with Acquired and Intervened Congenital Heart Disease: a Randomized Controlled Trial

Overview

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.

Interventions

  • Other cardiac rehabilitation program
    Cardiac rehabilitation program
  • Other TELEA platform
    TELEA platform

Primary outcome measures

  • Assessment of respiratory function/spirometry [Time frame: Baseline and immediately after the intervention]
Secondary outcome measures (2)
  • Assessment of the respiratory musculature [Time frame: Baseline and immediately after the intervention]
  • Functional capacity [Time frame: Baseline and immediately after the intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06185140 · CardiorrespiUSAL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗