Clinical trial NCT06580808: Inspiratory Training in Children After Fontan
Official title: Effects of Inspiratory Muscle Training in Children After Fontan Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Muscle Weakness
Keywords: congenital heart disease
Fontan procedure
rehabilitation
physiotherapy
inspiratory muscle training
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 45
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients in the Fontan group were randomized into the Fontan Training Group (FTG) and Fontan Control Group. The FTG performed inspiratory muscle training with the Power Breth device with an initial load of 40% of the maximum inspiratory pressure obtained by measuring the maximum inspiratory pressure by manovacuometry. The training lasted 2 months. The patient was asked to perform the training every day with 3 series of 20 breaths. The training was monitored in person and remotely by videoconference; the load was increased gradually when it was perceived that it was already easy or reported by the child.
Primary purpose: TREATMENT

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 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.

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 strength by manovacuometry, diaphragmatic mobility by ultrasound, quality of life by the AUQEI questionnaire. There are three groups, a healthy control group, a Fontan control group and a Fontan intervention group. The intervention will be done by respiratory muscle training using the Power Breath device.

Eligibility criteria: Inclusion Criteria:

* Age 8 to 12 years;
* Both sexes;
* No history of other heart disease;
* No history of lung and musculoskeletal diseases;
* \&gt;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.

Primary outcomes:
measure: Assessment of the diaphragm muscle
timeFrame: Baseline to 2 months
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: Baseline to 2 months
measure: Lung function test
timeFrame: Baseline to 2 months
measure: Six-minute walk test
timeFrame: Baseline to 2 months
measure: Change in quality of life measurement
timeFrame: Baseline to 2 months
measure: Improvement exercise tolerance and functional capacity (peak VO2)
timeFrame: Baseline to 2 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Intitute
Study officials:
affiliation: Heart Institute, University of São Paulo
name: Marcelo B Jatene, Manager
role: STUDY_DIRECTOR
affiliation: Heart Institute, University of São Paulo
name: Joao Bruno PD Silveira, Execution
role: PRINCIPAL_INVESTIGATOR
References: