Not Yet RecruitingNot Applicable

Effect of Exercises on Ventilatory Function in Adult With TOF

60 participantsStarted 2026-01-01

Plain-language 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

Who can participate

Age range

18 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

"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).

Timeframe: At Baseline and after 6 weeks of training

Trial details

NCT IDNCT07326228

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Tetralogy of Fallot (TOF) trials