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

NCT ID: NCT06185140

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Defects, Congenital

Keywords

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Exercise Physiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel randomized controlled trial with a simply assignment (1:1)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The study evaluator will not know the assignment of participants.

Study Groups

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Intervention group

Cardiac rehabilitation program

Group Type EXPERIMENTAL

cardiac rehabilitation program

Intervention Type OTHER

Cardiac rehabilitation program

Control group

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.

Group Type ACTIVE_COMPARATOR

TELEA platform

Intervention Type OTHER

TELEA platform

Interventions

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cardiac rehabilitation program

Cardiac rehabilitation program

Intervention Type OTHER

TELEA platform

TELEA platform

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Salamanca

OTHER

Sponsor Role lead

Responsible Party

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Juan Luis Sanchez Gonzalez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Juan Luis Sánchez González, Phd

Role: CONTACT

Phone: 660738949

Email: [email protected]

Other Identifiers

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CardiorrespiUSAL

Identifier Type: -

Identifier Source: org_study_id