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

27 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

32

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Berfin Kişin Sarıoğlu, MSc, PT
  • Numéro de téléphone: +905394671464
  • E-mail: kisinberfin@gmail.com

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

8 ans à 18 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.

Aucune intervention: Controlled group

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Inspiratory Muscle Strength
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Quality of Life Score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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%)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Directeur d'études: Gülşah Barğı, Assoc Prof, Izmir Democracy University
  • Chercheur principal: Berfin Kişin Sarıoğlu, MSc PT, Izmir Democracy University
  • Chercheur principal: Sema Savcı, Prof, Acibadem University
  • Chercheur principal: Mustafa Kır, Prof, Dokuz Eylul University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

1 juin 2028

Achèvement de l'étude (Estimé)

1 juin 2028

Dates d'inscription aux études

Première soumission

21 septembre 2026

Première soumission répondant aux critères de contrôle qualité

27 septembre 2026

Première publication (Réel)

2 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

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Informations sur les médicaments et les dispositifs, documents d'étude

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Étudie un produit d'appareil réglementé par la FDA américaine

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