An interventional study of aerobic exercise and respiratory muscle training in Tetralogy of Fallot (TOF) and Adults With Repaired Tetralogy of Fallot, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Cairo University · Not applicable, Interventional, and Supportive care
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:
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
93 studies on the registry are indexed under Tetralogy of Fallot; 26 are open to participants now.
This study's planned enrollment of 60 is above the median of 51 across 52 interventional studies indexed under Tetralogy of Fallot.
Browse Tetralogy of Fallot studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
bronchial asthma, lung fibrosis…..)
participants will receive respiratory muscle training via threshold IMT device in addition to moderate intensity aerobic exercise
Other: aerobic exercise · Other: respiratory muscle training
participants will receive moderate intensity aerobic exercise
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
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.
Also known as: Threshold inspiratory muscle training, inspiratory muscle training
"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).
Time frame: At Baseline and after 6 weeks of training
Change from Baseline in Six-minute walk test (6MWT)
Time frame: At Baseline and after 6 weeks of training
changes from baseline in 36-Item Short Form Health Survey (SF-36)
as an assessment of quality of live
Time frame: at Baseline and after 6 weeks of training
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Cairo University