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

Официальное название

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

Обзор

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.

Вмешательства

• Другое cardiac rehabilitation program
  Cardiac rehabilitation program
• Другое TELEA platform
  TELEA platform

Первичные конечные точки

• Assessment of respiratory function/spirometry [Срок оценки: Baseline and immediately after the intervention]

Вторичные конечные точки (2)

• Assessment of the respiratory musculature [Срок оценки: Baseline and immediately after the intervention]
• Functional capacity [Срок оценки: Baseline and immediately after the intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06185140 · CardiorrespiUSAL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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