[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658667":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":54,"studyPopulation":43,"armGroups":55,"interventions":67,"overallOfficials":76,"centralContacts":89,"locations":98,"responsibleParty":113,"collaborators":43,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":43,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":137,"overallStatus":144,"whyStopped":43,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Izmir Democracy University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":43},[9,13],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":15,"timeFrame":12},"Expiratory Muscle Strength","Expiratory muscle strength will be assessed with a spirometer. The highest value for expiratory pressure will be recorded.",[17,20,23,26,29,32,35,37,39,41],{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":12},"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.",{"measure":27,"description":28,"timeFrame":12},"Grip strength measurement","Grip strength will be measured using a standard, adjustable, and portable hydraulic hand dynamometer.",{"measure":30,"description":31,"timeFrame":12},"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.",{"measure":33,"description":34,"timeFrame":12},"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.",{"measure":36,"description":34,"timeFrame":12},"Forced expiratory volume in the first second (FEV1)",{"measure":38,"description":34,"timeFrame":12},"FEV1\u002FFVC",{"measure":40,"description":34,"timeFrame":12},"Flow rate 25-75% of forced expiratory volume (FEF 25-75%)",{"measure":42,"description":34,"timeFrame":12},"Peak flow rate (PEF)",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":43,"primaryPurpose":47,"observationalModel":43,"timePerspective":43,"maskingInfo":48},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":49,"maskingDescription":50,"whoMasked":51},"DOUBLE","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.",[52,53],"PARTICIPANT","OUTCOMES_ASSESSOR","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.",[56,63],{"label":57,"type":58,"description":59,"interventionNames":60},"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.",[61,62],"Other: Inspiratory Muscle Training","Other: Functional Inspiratory Muscle Training",{"label":64,"type":65,"description":66,"interventionNames":43},"Controlled group","NO_INTERVENTION","Participants in this group will continue with their routine daily lives.",[68,72],{"type":6,"name":69,"description":70,"armGroupLabels":71,"otherNames":43},"Inspiratory Muscle Training","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.",[57],{"type":6,"name":73,"description":74,"armGroupLabels":75,"otherNames":43},"Functional Inspiratory Muscle Training","Following basic IMT, simultaneous exercises (wall plank, wall lateral bridge, wall bridge, shoulder flexion\u002Fabduction, 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\u002Fsets (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.",[57],[77,80,83,86],{"name":78,"affiliation":5,"role":79},"Gülşah Barğı, Assoc Prof","STUDY_DIRECTOR",{"name":81,"affiliation":5,"role":82},"Berfin Kişin Sarıoğlu, MSc PT","PRINCIPAL_INVESTIGATOR",{"name":84,"affiliation":85,"role":82},"Sema Savcı, Prof","Acibadem University",{"name":87,"affiliation":88,"role":82},"Mustafa Kır, Prof","Dokuz Eylul University",[90,94],{"name":78,"role":91,"phone":92,"phoneExt":43,"email":93},"CONTACT","+90 232 299 0739","gulsahbargi35@gmail.com",{"name":95,"role":91,"phone":96,"phoneExt":43,"email":97},"Berfin Kişin Sarıoğlu, MSc, PT","+905394671464","kisinberfin@gmail.com",[99],{"facility":5,"status":43,"city":100,"state":43,"zip":101,"country":102,"countryCode":43,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"Izmir","35140","Turkey (Türkiye)",{"type":104,"coordinates":105},"Point",[106,107],27.13838,38.41273,{"lat":107,"lon":106},[110],{"name":78,"role":91,"phone":111,"phoneExt":43,"email":112},"+905317938766","gulsah.bargi@idu.edu.tr",{"type":82,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Gulsah Bargi","Associate Professor Dr","100658667","the-effect-of-telerehabilitation-exercises-in-children-with-congenital-heart-disease-100658667",false,"NCT07854171","The Effect of Telerehabilitation Exercises in Children With Congenital Heart Disease","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","CHD","Inclusion Criteria:\n\n* Having been diagnosed with CHD,\n* Being between 8 and 18 years of age,\n* Being in stage I, II, or III according to the New York Heart Association (NYHA) classification,\n* Having a stable clinical condition,\n* Volunteering to participate in the study.\n\nExclusion Criteria:\n\n* Having a history of any orthopedic or neurological disease that could interfere with the tests and exercises to be performed,\n* Having a history of any mental or psychological disease that could interfere with the tests and exercises to be performed,\n* Having any infection that could interfere with the tests and exercises to be performed,\n* Having undergone cardiac surgery within the last 6 months,\n* Having a contraindication for the exercise test.","ALL","8 Years","18 Years",{"count":128,"type":129},32,"ESTIMATED","INTERVENTIONAL",[132],"NA","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.",[135,136,73],"Congenital Heart Disease","Telerehabilitation",[138,139,140,141,142,143],"congenital heart disease","exercise","muscle strength","respiratory function tests","telerehabilitation","quality of life","NOT_YET_RECRUITING","2026-09-27",{"date":147,"type":148},"2026-10-02","ACTUAL",{"date":150,"type":129},"2026-10-01",{"date":152,"type":129},"2028-06-01",{"name":5,"class":6},1]