Please select the arm or intervention descriptions that belong 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: Arm Label: Aerobic Exercise Training Group; Type: ACTIVE_COMPARATOR; Interventions: Other: Aerobic Exercise Training | Arm Label: Inspiratory Muscle Training Group; Type: ACTIVE_COMPARATOR; Interventions: Other: Inspiratory Muscle Training | Arm Label: No Exercise Trainint Group; Type: ACTIVE_COMPARATOR; Interventions: Other: No Exercise Training | Intervention Type: OTHER; Name: Aerobic Exercise Training; Assigned to Arm(s): Aerobic Exercise Training Group | Intervention Type: OTHER; Name: Inspiratory Muscle Training; Assigned to Arm(s): Inspiratory Muscle Training Group | Intervention Type: OTHER; Name: No Exercise Training; Assigned to Arm(s): No Exercise Trainint Group
B: Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: One active intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: an mHealth intervention | Arm Label: The other active intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: an mHealth intervention | Intervention Type: BEHAVIORAL; Name: an mHealth intervention; Assigned to Arm(s): One active intervention group, The other active intervention group
C: Arm Label: Fitbit Only; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Physical Activity Monitoring | Arm Label: Fitbit + Coaching Sessions; Type: EXPERIMENTAL; Interventions: Behavioral: Physical Activity Lifestyle Intervention, Behavioral: Physical Activity Monitoring | Intervention Type: BEHAVIORAL; Name: Physical Activity Lifestyle Intervention; Assigned to Arm(s): Fitbit + Coaching Sessions | Intervention Type: BEHAVIORAL; Name: Physical Activity Monitoring; Assigned to Arm(s): Fitbit + Coaching Sessions, Fitbit Only
D: Arm Label: Aerobic training only; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise training | Arm Label: Combined aerobic and strength training; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise training | Intervention Type: BEHAVIORAL; Name: Exercise training; Assigned to Arm(s): Aerobic training only, Combined aerobic and strength training

Answer: A