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Inspiratory Training in Children After Fontan

NCT06580808 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-08-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Marcelo B Jatene, Manager · Heart Institute, University of São Paulo

  • Joao Bruno PD Silveira, Execution · Heart Institute, University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-27
Primary Completion
2024-01-13
Completion
2024-06-10

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06580808 on ClinicalTrials.gov