The Effect of Telerehabilitation Exercises in Children With Congenital Heart Disease

NCT07854171 | Not Yet Recruiting DMC

• 1 other identifier: Congenital Heart Disease
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Disease; Telerehabilitation; Functional Inspiratory Muscle Training

Keywords

congenital heart disease; exercise; muscle strength; respiratory function tests; telerehabilitation; quality of life

Outcome Measures

Primary Outcomes (2)

• Inspiratory Muscle Strength

  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

  Expiratory muscle strength will be assessed with a spirometer. The highest value for expiratory pressure will be recorded.

  Baseline and after 8-week

Secondary Outcomes (10)

• Quality of Life Score

  Baseline and after 8-week

• Exercise Capacity measurement

  Baseline and after 8-week

• Measurement of Functional Capacity

  Baseline and after 8-week

• Grip strength measurement

  Baseline and after 8-week

• Measurement of Back and Leg Strength

  Baseline and after 8-week

Study Arms (2)

İntervention group

EXPERIMENTAL

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.

Other: Inspiratory Muscle Training; Other: Functional Inspiratory Muscle Training

Controlled group

NO INTERVENTION

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

Interventions

Inspiratory Muscle Training OTHER

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.

İntervention group

Functional Inspiratory Muscle Training OTHER

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.

İntervention group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Izmir Democracy University

Izmir, 35140, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 42233987 BACKGROUND

• 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.

  PMID: 42648610 BACKGROUND

• 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.

  PMID: 42526776 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital; Motor Activity

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Officials

• Gülşah Barğı, Assoc Prof

  Izmir Democracy University

  STUDY DIRECTOR

• Berfin Kişin Sarıoğlu, MSc PT

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Sema Savcı, Prof

  Acibadem University

  PRINCIPAL INVESTIGATOR

• Mustafa Kır, Prof

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gülşah Barğı, Assoc Prof

CONTACT

+90 232 299 0739; gulsahbargi35@gmail.com

Berfin Kişin Sarıoğlu, MSc, PT

CONTACT

+905394671464; kisinberfin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In the double-blind study, the participants and the statistician were not informed about whether they were in the study group or the control group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: October 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)