Inspiratory Training in Children After Fontan

Effects of Inspiratory Muscle Training in Children After Fontan Surgery.

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Muscle Weakness
• Intervention / Treatment: Other: Fontan Training Group

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-900
    • Heart Intitute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Active Comparator: 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.	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the diaphragm muscle	The mobility and thickness of the diaphragm muscle were assessed using ultrasound in M mode. Both variables were analyzed during spontaneous, relaxed breathing in terms of both tidal volume and deep breathing at vital capacity. Muscle mobility was examined along the right and left mid-axillary and parasternal lines with volunteers in both the supine and sitting positions. Muscle thickness was measured while the patients were in the supine position along the mid-axillary lines during both natural, relaxed and deep breathing. Measurements were taken in centimeters, with the largest value selected from at least three reproducible measurements.	Baseline to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory muscle strength	Respiratory muscle strength was measured using maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) with a digital manometer calibrated beforehand. The MIP was determined by the maximal inspiratory effort from the residual volume (RV), and the MEP was determined by the maximal expiratory effort from the total lung capacity (TLC). At least three reproducible maneuvers were performed, with the largest value used unless it did not exceed the previous value by more than 20%.	Baseline to 2 months
Lung function test	Pulmonary volume and capacity were evaluated using the spirometer protocol as recommended by the American Thoracic Society guidelines. For spirometry, at least three acceptable and reproducible maneuvers at each stage were performed using encouragement and positive reinforcement to obtain maximum values. Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and the FEV1/FVC ratio were studied, and the predicted values were calculated from previously reported equations	Baseline to 2 months
Six-minute walk test	A submaximal analysis of physical capacity was conducted using the six-minute walk test (6MWT), following the protocol of the American Thoracic Society[16]. The patients were instructed to walk as quickly as possible without running for six minutes, while the distance covered was recorded. Breaks during the walk were allowed if needed. The data analyzed included the distance covered in meters, heart rate, respiratory rate, peripheral oxygen saturation, blood pressure, and the Modified Borg Scale for Fatigue. These measurements were taken at rest one minute before the test, immediately after the test, two minutes after the test if there was an interruption, and five minutes after the test.	Baseline to 2 months
Change in quality of life measurement	The evaluation of quality of life was conducted using the Self-imaginary Questionnaire on Children's Quality of Life (Autoquestionnaire Qualité de Vie Enfant Imagé). This scale consists of closed questions about the point of view for children aged 4 to 12 years, and their answers are directed toward 'very happy', 'happy', 'unhappy', or 'very unhappy', supported by an image of a child in these emotional states. The survey included 26 analysis items related to socialization, family relationships, activities, health, isolation, and other functions. The items were divided into factors such as autonomy, leisure, functions, family, and the legal value of the answers. The sum of all the questions generates a score with a maximum of 78. Scores less than 48 are considered to indicate a loss in quality of life. The questionnaire was validated and translated by Assumpçao et al.	Baseline to 2 months
Improvement exercise tolerance and functional capacity (peak VO2)	Change in functional capacity will be performed by cardiopulmonary exercise test and will be expressed by Peak VO2 and Predicted Peak VO2 (%). After the training program, an increase in the peak VO2(mL/kg/min) value between 10 to 15% is expected in relation to the baseline value.	Baseline to 2 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Study Director: Marcelo B Jatene, Manager, Heart Institute, University of São Paulo; Principal Investigator: Joao Bruno PD Silveira, Execution, Heart Institute, University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2017
• Primary Completion (Actual): January 13, 2024
• Study Completion (Actual): June 10, 2024

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: rehabilitation; physiotherapy; inspiratory muscle training; congenital heart disease; Fontan procedure
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Respiratory Aspiration; Muscle Weakness
• Other Study ID Numbers: 38501214.8.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: If any researcher has any questions about the research or wants to replicate it, I am available to clarify them. If any agency or entity has any questions about the results, they can be made available based on their confidentiality and ethical responsibility to be reanalyzed and reproduced.
• IPD Sharing Time Frame: The data will be available for possible checks at any time from now on.
• IPD Sharing Access Criteria: To access the data, if necessary, simply make a formal request and describe the reason for doing so.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No