Congenital Heart DiseaseCHDNCT07854171
The Effect of Telerehabilitation Exercises in Children With Congenital Heart Disease
A study testing Inspiratory Muscle Training and Functional Inspiratory Muscle Training in people with Congenital Heart Disease and Telerehabilitation, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Congenital Heart Disease, Telerehabilitation, Functional Inspiratory Muscle Training
- What is being tested?
- Inspiratory Muscle Training and Functional Inspiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Izmir Democracy University
Izmir, 35140
Gülşah Barğı, Assoc Prof, +905317938766, gulsah.bargi@idu.edu.tr
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Inspiratory Muscle Training, Functional Inspiratory Muscle Training
- Keywords
- congenital heart disease, exercise, muscle strength, respiratory function tests, telerehabilitation, quality of life
- Medical subject headings
- Heart Defects, Congenital, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
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.
Functional Inspiratory Muscle TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Inspiratory Muscle Training; Other: Functional Inspiratory Muscle Training |
| Controlled group | No intervention | Participants in this group will continue with their routine daily lives. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory Muscle Strength
Inspiratory muscle strength will be assessed with a spirometer. The highest value for inspiratory pressure will be recorded.
Measured: 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.
Measured: Baseline and after 8-week
Secondary outcomes (10)
Quality of Life Score
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.
Measured: Baseline and after 8-week
Exercise Capacity measurement
Maximal exercise capacity will be assessed using the Incremental Shuttle Walk Test. The number of shuttles completed after the test will be recorded.
Measured: Baseline and after 8-week
Measurement of Functional Capacity
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.
Measured: Baseline and after 8-week
Grip strength measurement
Grip strength will be measured using a standard, adjustable, and portable hydraulic hand dynamometer.
Measured: Baseline and after 8-week
Measurement of Back and Leg Strength
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.
Measured: Baseline and after 8-week
Forced vital capacity (FVC)
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.
Measured: Baseline and after 8-week
Forced expiratory volume in the first second (FEV1)
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.
Measured: Baseline and after 8-week
FEV1/FVC
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.
Measured: Baseline and after 8-week
Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
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.
Measured: Baseline and after 8-week
Peak flow rate (PEF)
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.
Measured: Baseline and after 8-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsah Bargi, Izmir Democracy University
- Investigators
- Gülşah Barğı, Assoc Prof, Study director, Izmir Democracy UniversityBerfin Kişin Sarıoğlu, MSc PT, Principal investigator, Izmir Democracy UniversitySema Savcı, Prof, Principal investigator, Acibadem UniversityMustafa Kır, Prof, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854171
- Sponsor's protocol ID
- Congenital Heart Disease
- Acronym
- CHD
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42233987Haas 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.
PubMed 42648610Dorobantu 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.
PubMed 42526776
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07854171
- Acronym / sponsor ID
- CHD / Congenital Heart Disease
- Keywords
- congenital heart disease, exercise, muscle strength, respiratory function tests, telerehabilitation, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervention group | Experimental | Other: Inspiratory Muscle Training, Other: Functional Inspiratory Muscle TrainingThe 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. |
| Controlled group | No intervention | –Participants in this group will continue with their routine daily lives. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle TrainingModerate-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. | Other | İntervention group |
| Functional Inspiratory Muscle TrainingFollowing 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. | Other | İntervention group |
Primary outcome
Inspiratory Muscle Strength
Time frame: Baseline and after 8-week
Inspiratory muscle strength will be assessed with a spirometer. The highest value for inspiratory pressure will be recorded.
Expiratory Muscle Strength
Time frame: Baseline and after 8-week
Expiratory muscle strength will be assessed with a spirometer. The highest value for expiratory pressure will be recorded.
10 secondary outcomes
Quality of Life Score
Time frame: Baseline and after 8-week
Exercise Capacity measurement
Time frame: Baseline and after 8-week
Measurement of Functional Capacity
Time frame: Baseline and after 8-week
Grip strength measurement
Time frame: Baseline and after 8-week
Measurement of Back and Leg Strength
Time frame: Baseline and after 8-week
Forced vital capacity (FVC)
Time frame: Baseline and after 8-week
Forced expiratory volume in the first second (FEV1)
Time frame: Baseline and after 8-week
FEV1/FVC
Time frame: Baseline and after 8-week
Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Time frame: Baseline and after 8-week
Peak flow rate (PEF)
Time frame: Baseline and after 8-week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 42233987Arnouts 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.
- Background: PubMed 42648610Haas 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.
- Background: PubMed 42526776Dorobantu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gülşah Barğı, Assoc Prof study director
Izmir Democracy University
Berfin Kişin Sarıoğlu, MSc PT principal investigator
Izmir Democracy University
Sema Savcı, Prof principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training and Functional Inspiratory Muscle Training in people with Congenital Heart Disease and Telerehabilitation, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gülşah Barğı, Assoc Prof (+90 232 299 0739, gulsahbargi35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory Muscle Strength (time frame: Baseline and after 8-week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07854171, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.