Effect of Exercises on Ventilatory Function in Adult With TOF

Официальное название

Effect of Combined Inspiratory Muscle Training and Aerobic Exercises on Ventilatory Function in Adults With Repaired Tetralogy of Fallot

Обзор

The goal of this clinical trial is to learn if combined inspiratory muscle training and aerobic exercise can improve ventilatory function in adults with repaired Tetralogy of Fallot (TOF). It will also learn if exercises work to raise functional capacity and Quality of life (QoL) . The main questions it aims to answer is: * Dose combined inspiratory muscle training and aerobic exercise (study group) improve ventilatory function in adults with repaired (TOF) more than aerobic exercise only (control group)? * Can combine inspiratory muscle training and aerobic exercise (study group) raise functional capacity and (QoL) in adults with repaired (TOF) more than aerobic exercise only (control group)? Researchers will compare between combination of inspiratory muscle training and aerobic exercise on one group and the aerobic exercise only on other group, on ventilatory function, functional capacity and (QoL) on adults with repaired TOF. Participants will: On study group , participants will perform respiratory muscle training in addition to moderate intensity aerobic exercise for 6 weeks. 3 times/week On controlled group , participants will perform moderate intensity aerobic exercise for 6 weeks. 3 times/week. all participants will test ventilatory function , functional capacity and will answer a survey questions about their quality of life before and after training

Вмешательства

• Другое aerobic exercise
  moderate intensity aerobic exercises on a treadmill: * Symptom-limited treadmill exercise training will be carried out at baseline for each participant following the modified Bruce protocol to estimate each participant's peak heart rate. * the target heart rate during training will be 50-60 % of each participant's heart rate reserve (moderate intensity exercise) * each session will have 5-10 min warm up, at least 20 min of moderate intensity aerobic exercise , and 5-10 min of cool down
• Другое respiratory muscle training
  respiratory muscle training via threshold inspiratory muscle trainer (IMT) device: * maximum inspiratory effort will be detected for each participant as the maximum resistance at which the participant can efficiently achieve 10 breathing cycles, via (Threshold IMT device) * the training will be initiated with a low-intensity load (20-30%) of the participant's maximum inspiratory effort via (Threshold IMT device). Then, the intensity will increase gradually by 5% according to the participant's t

Первичные конечные точки

• "Change from Baseline in Ventilatory function : Forced vital capacity (FVC) , Forced expiratory volume in 1 second (FEV1), expiratory vital capacity (EVC) and inspiratory vital capacity (IVC). [Срок оценки: At Baseline and after 6 weeks of training]

Вторичные конечные точки (2)

• Change from Baseline in Six-minute walk test (6MWT) [Срок оценки: At Baseline and after 6 weeks of training]
• changes from baseline in 36-Item Short Form Health Survey (SF-36) [Срок оценки: at Baseline and after 6 weeks of training]

Критерии участия

Критерии включения

• Diagnosed with TOF.
• Have surgical correction of the abnormality.
• Class II-III according to New York Heart Association (NYHA)
• Ejection fracture > 40
• Vitally stable during the study period

Критерии исключения

• Resent cardiopulmonary surgery or intervention "less than 6 months"
• Presence of pulmonary disease which is not a complication of TOF (eg:

bronchial asthma, lung fibrosis…..)

• Neuromuscular or musculoskeletal disease and severe scoliosis affecting pulmonary function or physical exercise.
• Mental or physical limitations
• active infection or systemic illness.
• Hemodynamic instability
• Mouth burn, injury, or deformities
• Implanted pacemaker

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07326228 · P.T.REC/012/005997

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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