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

Heart Defects, Congenital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06185140
• Other study ID #: CardiorrespiUSAL
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University of Salamanca
• Contact: Juan Luis Sánchez González, Phd
• Phone: 660738949
• Email: juanluissanchez[@]usal.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: December 31, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of respiratory function/spirometry	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	Baseline and immediately after the intervention
Secondary	Assessment of the respiratory musculature	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.	Baseline and immediately after the intervention
Secondary	Functional capacity	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	Baseline and immediately after the intervention