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

27. september 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

32

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

8 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Ingen inngripen: Controlled group

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Inspiratory Muscle Strength
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quality of Life Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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%)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. juni 2028

Studiet fullført (Antatt)

1. juni 2028

Datoer for studieregistrering

Først innsendt

21. september 2026

Først innsendt som oppfylte QC-kriteriene

27. september 2026

Først lagt ut (Faktiske)

2. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

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NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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