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

NCT06185140 | Not Yet Recruiting

• 1 other identifier: CardiorrespiUSAL
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Defects, Congenital

Keywords

Exercise; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Assessment of the respiratory musculature

  Baseline and immediately after the intervention

• Functional capacity

  Baseline and immediately after the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Cardiac rehabilitation program

Other: cardiac rehabilitation program

Control group

ACTIVE COMPARATOR

These patients will complete the program from their home through the TELEA platform that belongs to SERGAS. They go to the hospital once at the beginning of the program to learn the program with the Physiotherapist and once again after a month. The program will be carried out twice a week for their home. Patients will be monitored during physical exercise with Garmin® heart rate monitors. Patients will download heart rate and Borg scale data after each session and can establish contact through the TELEA platform with the nursing staff of the Cardiac RHB Unit at all times.

Other: TELEA platform

Interventions

cardiac rehabilitation program OTHER

Cardiac rehabilitation program

Intervention group

TELEA platform OTHER

TELEA platform

Control group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead

MeSH Terms

Conditions

Heart Defects, Congenital; Motor Activity

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Central Study Contacts

Juan Luis Sánchez González, Phd

CONTACT

660738949; juanluissanchez@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study evaluator will not know the assignment of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: parallel randomized controlled trial with a simply assignment (1:1)

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 29, 2023
• Study Start: January 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share