- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07854171
The Effect of Telerehabilitation Exercises in Children With Congenital Heart Disease (CHD)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Gülşah Barğı, Assoc Prof
- 전화번호: +90 232 299 0739
- 이메일: gulsahbargi35@gmail.com
연구 연락처 백업
- 이름: Berfin Kişin Sarıoğlu, MSc, PT
- 전화번호: +905394671464
- 이메일: kisinberfin@gmail.com
연구 장소
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Izmir, 터키 (Türkiye), 35140
- Izmir Democracy University
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연락하다:
- Gülşah Barğı, Assoc Prof
- 전화번호: +905317938766
- 이메일: gulsah.bargi@idu.edu.tr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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. |
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간섭 없음: Controlled group
Participants in this group will continue with their routine daily lives. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Inspiratory Muscle Strength
기간: Baseline and after 8-week
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Inspiratory muscle strength will be assessed with a spirometer. The highest value for inspiratory pressure will be recorded. |
Baseline and after 8-week
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Expiratory Muscle Strength
기간: Baseline and after 8-week
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Expiratory muscle strength will be assessed with a spirometer. The highest value for expiratory pressure will be recorded. |
Baseline and after 8-week
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Quality of Life Score
기간: Baseline and after 8-week
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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
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Exercise Capacity measurement
기간: Baseline and after 8-week
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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
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Measurement of Functional Capacity
기간: Baseline and after 8-week
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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
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Grip strength measurement
기간: Baseline and after 8-week
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Grip strength will be measured using a standard, adjustable, and portable hydraulic hand dynamometer. |
Baseline and after 8-week
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Measurement of Back and Leg Strength
기간: Baseline and after 8-week
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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
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Forced vital capacity (FVC)
기간: Baseline and after 8-week
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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
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Forced expiratory volume in the first second (FEV1)
기간: Baseline and after 8-week
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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
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FEV1/FVC
기간: Baseline and after 8-week
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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
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Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
기간: Baseline and after 8-week
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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
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Peak flow rate (PEF)
기간: Baseline and after 8-week
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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
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공동 작업자 및 조사자
수사관
- 연구 책임자: Gülşah Barğı, Assoc Prof, Izmir Democracy University
- 수석 연구원: Berfin Kişin Sarıoğlu, MSc PT, Izmir Democracy University
- 수석 연구원: Sema Savcı, Prof, Acibadem University
- 수석 연구원: Mustafa Kır, Prof, Dokuz Eylul University
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .