NCT07326228

Effect of Exercises on Ventilatory Function in Adult With TOF

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Tetralogy of Fallot (TOF)
• Adults With Repaired Tetralogy of Fallot

Interventions

Type	Name	Description
OTHER	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
OTHER	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 tolerance weekly until achieving 50% of maximum inspiratory effort. * the session will be formed of six sets, each set consisting of five deep breaths against the (Threshold IMT device), with a short interval of 1-2-minute rest between sets.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-31
• Completion: 2027-01-31
• First posted: 2026-01-08
• Last updated: 2026-01-08