CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Aerobic Exercise Training +2 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02283255
NCT02283255N/ACompleted

Cardiovascular, Pulmonary and Skeletal Muscle Evaluation in Patients With Univentricular Physiology in the Late Postoperative Period of the Fontan Surgery: Effects of Exercise Training

University of Sao Paulo·interventional·Posted Nov 5, 2014·Updated Dec 7, 2022

In Brief

A clinical study evaluating Aerobic Exercise Training, Inspiratory Muscle Training, and 1 other intervention for Congenital Heart Disease and 2 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Introduction: The Fontan operation is the surgical treatment in most patients with either anatomic or functional single ventricles. In this operation, the subpulmonary ventricle is bypassed, connecting the systemic veins directly to the pulmonary arteries. The lack of a subpulmonary ventricle is associated with a nonpulsatile pulmonary flow and triggers a sequence of adaptive mechanisms along the life of these patients. The most frequent consequence of these adaptative mechanisms is the reduction in functional capacity, objectively measured by the decrease in peak oxygen consumption (VO2). So, cardiovascular and pulmonary functioning and skeletal muscle alterations can explain exercise intolerance in these patients. Objectives: 1. To compare the cardiovascular, pulmonary, and musculoskeletal system variables in clinically stable Fontan patients with Healthy subjects; 2. To correlate the variables of the cardiovascular, pulmonary, and skeletal muscle with the functional capacity in Fontan patients; 3. To identify predictors of low functional capacity in this population; 4. To evaluate four-month aerobic exercise and inspiratory muscle training on functional capacity, pulmonary function, and autonomic control in patients after Fontan operation and compare to the group with no exercise training. Methods: All subjects were submitted to cardiovascular, pulmonary, and skeletal muscle evaluation at baseline to perform a cross-sectional study comparing Fontan Patients (FP) with Healthy Controls (HC). In addition, the FP accepted to participate in the longitudinal clinical trial to evaluate exercise programs were randomized into three groups: Aerobic Exercise Training (AET), Inspiratory Muscle Training (IMT), and Non-exercise Training Group (NET, a control group). All patient groups (AET, IMT, NET) were reassessed after four months of training or under usual care. Expected Outcomes: This study expects to demonstrate that impaired pulmonary function, altered neurovascular control, and reduced skeletal muscle could be an additional potential mechanism for reducing functional capacity in clinically stable Fontan patients. And this impairment could be diminished by exercise training, enhancing physical capacity, and exercise tolerance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 5, 2014
Enrollment StartJan 31, 2013
Primary CompletionJan 30, 2016
Study CompletionOct 30, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 11.7 years ago

Interventions

Aerobic Exercise Trainingother

Supervised aerobic and light muscle resistance exercise training

Inspiratory Muscle Trainingother

Inspiratory muscle training with POWERbreathe device

No Exercise Trainingother

Usual care