CompletedNot Applicable

Inspiratory Training in Children After Fontan

Brazil45 participantsStarted 2017-09-27

Plain-language summary

This study will assess physical and respiratory capacity, diaphragmatic mobility and quality of life. Healthy children and children who have undergone Fontan surgery will participate. Some children in the late postoperative period of Fontan surgery will be randomized to a group of inspiratory muscle training that will last for 2 months. Children after Fontan surgery will be evaluated twice, once at the beginning and again after two months of follow-up.

Who can participate

Age range

8 Years – 12 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: * Age 8 to 12 years; * Both sexes; * No history of other heart disease; * No history of lung and musculoskeletal diseases; * \>1 year post-operative Fontan Surgery; * Clinically stable; * Absence of serious arrhythmias; * Medical clearance to participate in the study; The legal guardian has agreed to participate in the research and the child has consented Exclusion Criteria: * Musculoskeletal alterations; * Patients with neurological sequelae; * Patients with genetic syndromes associated with cognitive or psychiatric disorders; * History of perioperative arrhythmias; * Patients with uncontrolled heart failure; * Recent angina; * Severe arrhythmia; * Hemoptysis; * Pulmonary hypertension; * Diaphragmatic plication; * Moderate to severe asthma.

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

Assessment of the diaphragm muscle

Timeframe: Baseline to 2 months

Trial details

NCT IDNCT06580808

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-13

View on ClinicalTrials.gov More Respiratory Muscle Weakness trials