Inspiratory Training in Children After Fontan

NCT ID: NCT06580808

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-27
• Study Completion Date: 2024-06-10

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.

Conditions

Respiratory Muscle Weakness

Keywords

congenital heart disease; Fontan procedure; rehabilitation; physiotherapy; inspiratory muscle training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

The control group consisted of 18 healthy children. These children underwent cardiopulmonary testing, spirometry, chest ultrasound to assess the diaphragm, 6-minute walk test, respiratory muscle strength and quality of life. These tests were performed to assess the results of these tests in patients without previous illnesses.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Fontan Training Group

The Fonta training group consisted of 14 children in the late postoperative period of Fontan surgery. These children underwent cardiopulmonary testing, spirometry, chest ultrasound to assess the diaphragm, 6-minute walk test, respiratory muscle strength and quality of life. These tests were performed at the initial stage and after two months of inspiratory muscle training to assess the results of these in postoperative patients and what changes the training could bring. The training was performed with the Power Breath device, the carda was quantified at 40% of the force exerted at maximum inspiratory pressure by manovacuometry. The patient was asked to perform 3 sets of 20 repetitions twice over the course of 7 days of the week. Monitoring was done in person and virtually, and the carda was increased according to the evaluator's perception of the ease of the exercise or if the patient reported it to be easy. The training lasted 2 months.

Group Type: ACTIVE_COMPARATOR

Fontan Training Group

Intervention Type: OTHER

The Fonta training group consisted of 14 children in the late postoperative period of Fontan surgery. These children underwent cardiopulmonary testing, spirometry, chest ultrasound to assess the diaphragm, 6-minute walk test, respiratory muscle strength and quality of life. These tests were performed at the initial stage and after two months of inspiratory muscle training to assess the results of these in postoperative patients and what changes the training could bring. The training was performed with the Power Breath device, the carda was quantified at 40% of the force exerted at maximum inspiratory pressure by manovacuometry. The patient was asked to perform 3 sets of 20 repetitions twice over the course of 7 days of the week. Monitoring was done in person and virtually, and the carda was increased according to the evaluator's perception of the ease of the exercise or if the patient reported it to be easy. The training lasted 2 months.

Fonta Control Group

The Fonta Control Group consisted of 13 children in the late postoperative period of Fontan surgery. These children underwent cardiopulmonary testing, spirometry, chest ultrasound to assess the diaphragm, 6-minute walk test, respiratory muscle strength and quality of life. These tests were performed at the initial stage and after two months to assess the results of these tests in postoperative patients and whether there was any normal behavior.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fontan Training Group

The Fonta training group consisted of 14 children in the late postoperative period of Fontan surgery. These children underwent cardiopulmonary testing, spirometry, chest ultrasound to assess the diaphragm, 6-minute walk test, respiratory muscle strength and quality of life. These tests were performed at the initial stage and after two months of inspiratory muscle training to assess the results of these in postoperative patients and what changes the training could bring. The training was performed with the Power Breath device, the carda was quantified at 40% of the force exerted at maximum inspiratory pressure by manovacuometry. The patient was asked to perform 3 sets of 20 repetitions twice over the course of 7 days of the week. Monitoring was done in person and virtually, and the carda was increased according to the evaluator's perception of the ease of the exercise or if the patient reported it to be easy. The training lasted 2 months.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcelo B Jatene, Manager

Role: STUDY_DIRECTOR

Heart Institute, University of São Paulo

Joao Bruno PD Silveira, Execution

Role: PRINCIPAL_INVESTIGATOR

Heart Institute, University of São Paulo

Locations

Heart Intitute

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

38501214.8.0000.0068

Identifier Type: -

Identifier Source: org_study_id