Inspiratory Training in Children After Fontan

NCT06580808 | Completed

• 1 other identifier: 38501214.8.0000.0068
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Muscle Weakness

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Respiratory muscle strength

  Baseline to 2 months

• Lung function test

  Baseline to 2 months

• Six-minute walk test

  Baseline to 2 months

• Change in quality of life measurement

  Baseline to 2 months

• Improvement exercise tolerance and functional capacity (peak VO2)

  Baseline to 2 months

Study Arms (3)

Control Group

NO INTERVENTION

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.

Fontan Training Group

ACTIVE COMPARATOR

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

Fonta Control Group

NO INTERVENTION

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.

Interventions

Fontan Training Group 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.

Fontan Training Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Heart Intitute

São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Marcelo B Jatene, Manager

  Heart Institute, University of São Paulo

  STUDY DIRECTOR

• Joao Bruno PD Silveira, Execution

  Heart Institute, University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 30, 2024
• Study Start: September 27, 2017
• Primary Completion: January 13, 2024
• Study Completion: June 10, 2024
• Last Updated: August 30, 2024

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be available for possible checks at any time from now on.
• Access Criteria: To access the data, if necessary, simply make a formal request and describe the reason for doing so.

Locations

BR (1)