Please select the eligibility criteria that correspond to the clinical trial below.
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
Brief 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.


Options:
A: Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* age ≥ 18 years
* known cardiomyopathy from acquired heart disease (ischemic or dilated) or patients with complex CHD (cyanotic congenital heart disease, Fontan palliation, subaortic right ventricle or repaired tetralogy of Fallot)

Exclusion Criteria:

* Acute coronary syndrome, cardiac surgery or heart failure hospitalization within the previous 6 months
* chronic metabolic, orthopedic, or infectious disease; treatment with steroids, hormones, or cancer chemotherapy
* severe exercise-induced asthma
* professional singer or professionally performing a wind instrument
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
B: Inclusion Criteria:

* Any condition indicated for cardiac rehabilitation: Acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft +/- valve surgery or procedure (e.g., TAVI), heart transplant, ventricular assist device, heart failure, arrhythmia, rhythm device (i.e. implantable cardioverter-defibrillator, cardiac resynchronization therapy, pacemaker), congenital heart disease, minor non-disabling stroke or transient ischemic attack (i.e., can ambulate), peripheral vascular disease
* Proficiency in English language

Exclusion Criteria:

* Any musculoskeletal, neuromuscular, visual, cognitive or non-dysphoric psychiatric condition, or any serious or terminal illness not otherwise specified which would preclude CR eligibility based on CR guidelines
* Being discharged to long-term care
* Inability to ambulate (i.e. walk unaided at 2mph)
C: 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
D: Inclusion Criteria:

* Patient aged 13 to 25 years included
* With a congenital heart diseases (CHD) as defined in the international CHD classification.
* Recent (\< 3 months) cardio-pulmonary exercise test (CPET)with maximum oxygen uptake (VO2max) \<80% of theoretical values and/or first ventilatory anaerovic threshold (VAT) \<55% of VO2max.
* Consent of the adult patient or the parents or legal guardians of the minor patient.
* Beneficiary of the social security scheme.

Exclusion Criteria:

* Uncontrolled arrhythmia.
* Cardiac surgery planned during the rehabilitation program.
* Severe musculoskeletal disorders.
* Severe intellectual disability that does not allow the quality of life questionnaire to be completed.
* Pregnancy.
* Patient who already underwent cardiac rehabilitation in the last 24 months.
* All medical contraindications to perform a cardiorespiratory stress test.
* Uncontrolled heart failure (NYHA IV)
* Obesity (BMI \> 30)

Answer: C