Physical Rehabilitation in Patients With Complex Congenital Heart Disease (NCT07089264) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Physical Rehabilitation in Patients With Complex Congenital Heart Disease
Brazil20 participantsStarted 2019-09-01
Plain-language summary
Studies have shown that patients with congenital heart disease have functional changes compared to healthy individuals. Several interventions can be performed to minimize these changes; physical rehabilitation is one of these possible treatments that can generate numerous benefits for patients. The aim of this study is to evaluate the response to physical rehabilitation in patients after surgical correction of congenital heart disease.
Methods This cross-sectional study included patients with complex congenital heart disease who underwent surgical correction. Different examinations were performed: cardiopulmonary exercise was used; and the six-minute walk test was used to determine functional capacity, the quality of life cardiac version questionnaire was used to determine quality of life. Descriptive analysis of patients was performed for all the data.
Who can participate
Age range
4 Years – 18 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:
* no previous or current history of other non-cardiological disease
* patients undergoing complex congenital heart surgeries with a minimum postoperative period of 1 year
* clinically stable; with no complex arrhythmia(s) in the last electrocardiogram or clinical evaluation
* with medical monitoring
* clinical clearance to carry out the protocols
* consent with the Free and Informed Consent Form (FICF) and Assent Form signed by the guardian and the patient respectively.
Exclusion Criteria:
* patients with musculoskeletal or neuropsychiatric alterations without the possibility of performing a functional test (ergospirometry test),
* hemodynamically unstable patients
* severe respiratory or metabolic conditions
* patients residing in regions far from São Paulo,
* patients which make frequent visits to the institution unfeasible
* patients who do not attend the rehabilitation program or those for whom it was not possible to maintain and update registration data.
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
1
Evaluate the response to aerobic activity and peripheral muscle strength training in children with congenital heart disease.
Timeframe: In 36 physical rehabilitation sessions, twice a week lasting about 4.5 weeks