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

27 september 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

32

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

8 jaar tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.

Geen tussenkomst: Controlled group

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Inspiratory Muscle Strength
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Quality of Life Score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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%)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie directeur: Gülşah Barğı, Assoc Prof, Izmir Democracy University
  • Hoofdonderzoeker: Berfin Kişin Sarıoğlu, MSc PT, Izmir Democracy University
  • Hoofdonderzoeker: Sema Savcı, Prof, Acibadem University
  • Hoofdonderzoeker: Mustafa Kır, Prof, Dokuz Eylul University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 juni 2028

Studie voltooiing (Geschat)

1 juni 2028

Studieregistratiedata

Eerst ingediend

21 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 september 2026

Eerst geplaatst (Werkelijk)

2 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

27 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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