Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

The Effect of Telerehabilitation Exercises in Children With Congenital Heart Disease (CHD)

27 de septiembre de 2026 actualizado por: Gulsah Bargi, Izmir Democracy University

The Effect of Telerehabilitation-based Functional Inspiratory Muscle Training on Respiratory Function, Muscle Strength, Exercise Capacity, and Quality of Life in Children With Congenital Heart Disease

This study aims to investigate the effects of functional inspiratory muscle training on physical performance and quality of life in pediatric patients with congenital heart disease.

Descripción general del estudio

Descripción detallada

Congenital heart disease (CHD) is a common condition in newborns. As a congenital disorder, CHD is the leading cause of infant mortality. Recent advances in medical treatment and surgical procedures have improved survival rates among children with CHD. However, despite these developments, children with CHD may still exhibit muscle weakness, physical inactivity, reduced performance in activities of daily living, and a decline in health-related quality of life. Therefore, this study aims to investigate the effects of functional inspiratory muscle training on physical performance and quality of life in pediatric patients with CHD.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

32

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Gülşah Barğı, Assoc Prof
  • Número de teléfono: +90 232 299 0739
  • Correo electrónico: gulsahbargi35@gmail.com

Copia de seguridad de contactos de estudio

  • Nombre: Berfin Kişin Sarıoğlu, MSc, PT
  • Número de teléfono: +905394671464
  • Correo electrónico: kisinberfin@gmail.com

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

8 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Having been diagnosed with CHD,
  • Being between 8 and 18 years of age,
  • Being in stage I, II, or III according to the New York Heart Association (NYHA) classification,
  • Having a stable clinical condition,
  • Volunteering to participate in the study.

Exclusion Criteria:

  • Having a history of any orthopedic or neurological disease that could interfere with the tests and exercises to be performed,
  • Having a history of any mental or psychological disease that could interfere with the tests and exercises to be performed,
  • Having any infection that could interfere with the tests and exercises to be performed,
  • Having undergone cardiac surgery within the last 6 months,
  • Having a contraindication for the exercise test.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: İntervention group

The telerehabilitation program will last a total of 8 weeks and will consist of two parts: 4 weeks of inspiratory muscle training and 4 weeks of functional inspiratory muscle training. The training program will be held every day of the week, with 3 of those days conducted under the supervision of a physiotherapist.

Moderate-intensity basic inspiratory muscle training will be provided using a threshold pressure loading device (POWERBreathe) for the first four weeks, starting at 30% of MIP and gradually increasing to 50% depending on the participant's tolerance. The training will be conducted twice daily, 15 minutes in the morning and 15 minutes in the evening, for a total of 30 minutes. With the device, the patient will perform 5-10 deep breathing cycles, then remove the device and perform 3-5 calm breaths to control their breathing. At the end of each day, the physiotherapist will communicate with the patients to assess their progress in the exercise and record it in the exercise log.

Following basic IMT, simultaneous exercises (wall plank, wall lateral bridge, wall bridge, shoulder flexion/abduction, elbow flexion, trunk rotation, squat-stand, standing leg raise, walking) will be performed for 4 weeks. Abdominal muscle activation will be taught at the beginning of the training, and functional exercises, paying attention to abdominal stabilization, will continue throughout the training sessions. Moderate intensity IMT will be applied, starting from 30% of the MIP and increasing up to 50% depending on the participant's tolerance. While using the device, the patient will take 5-10 deep breaths and simultaneously perform the functional exercises in sequence, each with 5-10 repetitions/sets (1-3 sets per day). Then, they will remove the device from their mouth and practice breath control by taking 3-5 calm breaths. Exercises that the patient cannot perform will be recorded.

Sin intervención: Controlled group

Participants in this group will continue with their routine daily lives.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Inspiratory Muscle Strength
Periodo de tiempo: Baseline and after 8-week

Inspiratory muscle strength will be assessed with a spirometer. The highest value for inspiratory pressure will be recorded.

Baseline and after 8-week
Expiratory Muscle Strength
Periodo de tiempo: Baseline and after 8-week

Expiratory muscle strength will be assessed with a spirometer. The highest value for expiratory pressure will be recorded.

Baseline and after 8-week

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Quality of Life Score
Periodo de tiempo: Baseline and after 8-week

The Pediatric Quality of Life Inventory 3.0 Cardiac Module will be assessed using Turkish versions of the 8-12 and 13-18 year old child and parent forms. A minimum score of 0 and a maximum score of 100 can be obtained on the scale; a higher score indicates a higher quality of life.

Baseline and after 8-week
Exercise Capacity measurement
Periodo de tiempo: Baseline and after 8-week

Maximal exercise capacity will be assessed using the Incremental Shuttle Walk Test. The number of shuttles completed after the test will be recorded.

Baseline and after 8-week
Measurement of Functional Capacity
Periodo de tiempo: Baseline and after 8-week

Functional capacity will be assessed using the 1-minute sit-to-stand test, and the number of sit-to-stand repetitions performed in one minute will be recorded.

Baseline and after 8-week
Grip strength measurement
Periodo de tiempo: Baseline and after 8-week

Grip strength will be measured using a standard, adjustable, and portable hydraulic hand dynamometer.

Baseline and after 8-week
Measurement of Back and Leg Strength
Periodo de tiempo: Baseline and after 8-week

Back and leg strength will be measured using a Saehan standard platform back-leg-chest dynamometer. The best value recorded from the dynamometer after three trials will be noted in kilograms.

Baseline and after 8-week
Forced vital capacity (FVC)
Periodo de tiempo: Baseline and after 8-week

Lung function will be assessed with a spirometer. The highest value of the three measurements will be used and interpreted according to gender, age, weight and height.

Baseline and after 8-week
Forced expiratory volume in the first second (FEV1)
Periodo de tiempo: Baseline and after 8-week

Lung function will be assessed with a spirometer. The highest value of the three measurements will be used and interpreted according to gender, age, weight and height.

Baseline and after 8-week
FEV1/FVC
Periodo de tiempo: Baseline and after 8-week

Lung function will be assessed with a spirometer. The highest value of the three measurements will be used and interpreted according to gender, age, weight and height.

Baseline and after 8-week
Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Periodo de tiempo: Baseline and after 8-week

Lung function will be assessed with a spirometer. The highest value of the three measurements will be used and interpreted according to gender, age, weight and height.

Baseline and after 8-week
Peak flow rate (PEF)
Periodo de tiempo: Baseline and after 8-week

Lung function will be assessed with a spirometer. The highest value of the three measurements will be used and interpreted according to gender, age, weight and height.

Baseline and after 8-week

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Director de estudio: Gülşah Barğı, Assoc Prof, Izmir Democracy University
  • Investigador principal: Berfin Kişin Sarıoğlu, MSc PT, Izmir Democracy University
  • Investigador principal: Sema Savcı, Prof, Acibadem University
  • Investigador principal: Mustafa Kır, Prof, Dokuz Eylul University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

1 de junio de 2028

Finalización del estudio (Estimado)

1 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

21 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de septiembre de 2026

Publicado por primera vez (Actual)

2 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir