Status:
COMPLETED
Inspiratory Training in Children After Fontan
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Respiratory Muscle Weakness
Eligibility:
All Genders
8-12 years
Phase:
NA
Brief 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...
Detailed Description
This study aims to evaluate physical capacity through cardiopulmonary testing, submaximal physical capacity testing by the 6-minute walk test, respiratory capacity by spirometry, respiratory muscle st...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06580808
Start Date
September 27 2017
End Date
June 10 2024
Last Update
August 30 2024
Active Locations (1)
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1
Heart Intitute
São Paulo, Brazil, 05403-900