Congenital Heart Disease Clinical Trial
Official title:
Cardiovascular, Pulmonary and Skeletal Muscle Evaluation in Patients With Univentricular Physiology in the Late Postoperative Period of the Fontan Surgery: Effects of Exercise Training
Verified date | December 2022 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 30, 2020 |
Est. primary completion date | January 30, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 30 Years |
Eligibility | Inclusion Criteria: - Both gender, aged between 12 and 30 years - Patients undergoing the Fontan operation with time postoperatively =5 years - Clinically stable patients, no arrhythmia in the last electrocardiogram or clinical assessment - Consent by the cardiologist - Patients who voluntarily signed the consent form. Exclusion Criteria: - Patients with hypoplastic left heart syndrome - Changes that reduce musculoskeletal walking skills - Neurological sequelae, patients with associated genetic syndrome, disturbance cognitive or psychiatric - Patients with a history of ventricular arrhythmias, cardio respiratory arrest, users of anti-arrhythmic drugs and / or underwent implantation of pacemaker - Atrial arrhythmia requiring treatment in the last 6 months - Patients with heart failure not controlled by medications and lung hypertension - Patients with protein-losing enteropathy - Severe hypoxemia (oxygen saturation <80% at rest) - Symptomatic patients with a diagnosis of diaphragmatic paresis or paralysis postoperative patients, with or without plication - Patients with moderate to severe asthma - Patients who live outside the area of Sao Paulo |
Country | Name | City | State |
---|---|---|---|
Brazil | InCor Heart Institute | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Improvement in the functional capacity post exercise training program | Increase at least 20% cardiopulmonary exercise test parameters: VO2 peak, oxygen pulse and VE/VCO2 slope | baseline and 4 months | |
Other | Improvement in pulmonary function post physical exercise program | Achieve at least 80% of predicted values for age at pulmonary function testing: spirometry, plethysmography, carbon monoxide diffusion capacity and maximal inspiratory pressure | baseline and 4 months | |
Other | Change in autonomic function post exercise training program | Decrease bursts/min and bursts per 100 heart beats by at least 20% from baseline by directly measured by microneurography : direct muscle sympathetic nerve activity (MSNA) | baseline and 4 months | |
Other | Improvement in peripheral blood flow post exercise training program | Increase forearm blood flow in mL/min/100mL | baseline and 4 months | |
Other | Change in the plasma epinephrine level post exercise training program | Decrease of plasma epinephrine level from baseline | baseline and 4 months | |
Other | Change in muscle metabolism post exercise training program | Increase of the amplitudes of the phosphocreatine, inorganic phosphate and ATP from baseline by 31P-MRS: Quadriceps femoral 31P-MRS | baseline and 4 months | |
Primary | Improvement exercise tolerance and physical capacity | Change in parameters by cardiopulmonary exercise test; increase in lung volumes and capacities; improvement by neurovascular control and skeletical muscle metabolism | Baseline and 4 months |
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