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NCT Number: NCT06185140

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac rehabilitation program

Other

Cardiac rehabilitation program

TELEA platform

Other

TELEA platform

Primary outcomes

  1. Assessment of respiratory function/spirometry

    Time frame: Baseline and immediately after the intervention

    Spirometry is the study of choice in pulmonary function laboratories. The parameters it measures are the volume of air that the child breathes in or out in absolute value or related to time, and is shown in the volume/time curve. The most useful functional parameters obtained after spirometry are forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), PEF and the FEV1 /FVC ratio

Secondary outcomes

  1. Assessment of the respiratory musculature

    Time frame: Baseline and immediately after the intervention

    Volumetric Incentivator: The child will be placed in a seated position with feet on the floor and keeping the device in an upright position. The physiotherapist will ask the patient to exhale slowly and prolonged until the RV is reached and then perform a maximum inspiration through the mouthpiece ensuring lip sealing. The highest value of three procedures performed will be recorded as a reference for the intervention.

  2. Functional capacity

    Time frame: Baseline and immediately after the intervention

    Pediatric treadmill ergospirometry will be used. This test is able to noninvasively evaluate the functional capacity of the child and to a lesser extent for the diagnosis of ischemic events

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Luis Sánchez González, Phd

CONTACT

[email protected]

660738949

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 29, 2023
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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