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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Gülşah Barğı, Assoc Prof
- Numero di telefono: +90 232 299 0739
- Email: gulsahbargi35@gmail.com
Backup dei contatti dello studio
- Nome: Berfin Kişin Sarıoğlu, MSc, PT
- Numero di telefono: +905394671464
- Email: kisinberfin@gmail.com
Luoghi di studio
-
-
-
Izmir, Turchia (Türkiye), 35140
- Izmir Democracy University
-
Contatto:
- Gülşah Barğı, Assoc Prof
- Numero di telefono: +905317938766
- Email: gulsah.bargi@idu.edu.tr
-
-
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Nessun intervento: Controlled group
Participants in this group will continue with their routine daily lives. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Inspiratory Muscle Strength
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Quality of Life Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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%)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Gülşah Barğı, Assoc Prof, Izmir Democracy University
- Investigatore principale: Berfin Kişin Sarıoğlu, MSc PT, Izmir Democracy University
- Investigatore principale: Sema Savcı, Prof, Acibadem University
- Investigatore principale: Mustafa Kır, Prof, Dokuz Eylul University
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- Congenital Heart Disease
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .