- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07854171
The Effect of Telerehabilitation Exercises in Children With Congenital Heart Disease (CHD)
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
Statut
Les conditions
Intervention / Traitement
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
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Gülşah Barğı, Assoc Prof
- Numéro de téléphone: +90 232 299 0739
- E-mail: gulsahbargi35@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Berfin Kişin Sarıoğlu, MSc, PT
- Numéro de téléphone: +905394671464
- E-mail: kisinberfin@gmail.com
Lieux d'étude
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Izmir, Turquie (Türkiye), 35140
- Izmir Democracy University
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Contact:
- Gülşah Barğı, Assoc Prof
- Numéro de téléphone: +905317938766
- E-mail: gulsah.bargi@idu.edu.tr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
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
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 |
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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. |
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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 |
|---|---|---|
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Inspiratory Muscle Strength
Délai: Baseline and after 8-week
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Inspiratory muscle strength will be assessed with a spirometer. The highest value for inspiratory pressure will be recorded. |
Baseline and after 8-week
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Expiratory Muscle Strength
Délai: Baseline and after 8-week
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Expiratory muscle strength will be assessed with a spirometer. The highest value for expiratory pressure will be recorded. |
Baseline and after 8-week
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Quality of Life Score
Délai: Baseline and after 8-week
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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
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Exercise Capacity measurement
Délai: Baseline and after 8-week
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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
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Measurement of Functional Capacity
Délai: Baseline and after 8-week
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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
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Grip strength measurement
Délai: Baseline and after 8-week
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Grip strength will be measured using a standard, adjustable, and portable hydraulic hand dynamometer. |
Baseline and after 8-week
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Measurement of Back and Leg Strength
Délai: Baseline and after 8-week
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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
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Forced vital capacity (FVC)
Délai: Baseline and after 8-week
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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
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Forced expiratory volume in the first second (FEV1)
Délai: Baseline and after 8-week
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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
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FEV1/FVC
Délai: Baseline and after 8-week
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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
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Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Délai: Baseline and after 8-week
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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
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Peak flow rate (PEF)
Délai: Baseline and after 8-week
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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
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Collaborateurs et enquêteurs
Parrainer
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
Publications générales
- Arnouts EC, Drysdale ND, Gerstner Saucedo J, Gonzalez de Alba C, Malone LJ, Fonseca B, DiMaria MV, Browne LP, Barker AJ. Examination of elevated myocardial extracellular volume and exercise capacity in pediatric Fontan patients at moderate altitude. Pediatr Radiol. 2026 Sep;56(10):2260-2271. doi: 10.1007/s00247-026-06675-2. Epub 2026 Jun 3.
- Haas SD, van der Hulst AE, Widyanti AP, van Schuppen J, Oosterlaan J, van den Aardweg JG, Ten Harkel ADJ, Kuipers IM, Blom NA. Cardiorespiratory fitness in children with surgically corrected congenital heart disease: Exercise testing profiles and biventricular function. Am Heart J. 2026 Aug 26;303:107590. doi: 10.1016/j.ahj.2026.107590. Online ahead of print.
- Dorobantu DM, van de Bruaene A, Budts W, Cifra B, Friedberg MK, Fritsch P, Khoury M, Muller J, Opotowsky A, Sanatani S, Williams C, Hansmann G, Pieles GE. Sports and Supervised Exercise Programmes for Children and Young Adults with Pulmonary Hypertension. 2026 Consensus Statement from the European Pediatric Pulmonary Vascular Disease Network (EPPVDN) and the Association for European Paediatric and Congenital Cardiology (AEPC). J Heart Lung Transplant. 2026 Jul 29:S1053-2498(26)02015-2. doi: 10.1016/j.healun.2026.07.026. Online ahead of print.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Congenital Heart Disease
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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