Preliminary Efficacy of a Remote Cardiac Rehabilitation Program in Pediatric Patients With Complex Congenital Heart Disease

Measured by Cardiopulmonary Exercise Test (CPET) using the OSAKA protocol. It assesses the maximal amount of oxygen the body can utilize during exercise.

Health-related quality of life assessed by the PedsQL questionnaire. Total scores range from 0 to 100, where higher scores indicate a better outcome (higher health-related quality of life).

Calculated as the number of participated sessions divided by the total number of provided sessions (%).

Percentage of participants who dropped out related to the intervention

Measured by an accelerometer (GENEActiv) worn for 7 days and smartwatch data.

Assesses levels of physical activity in three domains (activity at work/school, travel to and from places, recreational activities) and sedentary behavior. The Global Physical Activity Questionnaire (GPAQ) calculates physical activity volume in Metabolic Equivalent of Task (MET)-minutes per week, with a minimum value of 0 and no defined maximum limit, where higher values indicate a better outcome (greater physical activity).

Assesses health-related quality of life of the pediatric patient from the perspective of the parents or guardians. Total scores range from 0 to 100, where higher scores indicate a better outcome (higher health-related quality of life).

A disease-specific module designed to measure health-related quality of life specifically in pediatric patients with heart disease. Total scores range from 0 to 100, where higher scores indicate a better outcome (better disease-specific quality of life).

A disease-specific module designed to measure health-related quality of life specifically in parent proxy-report of pediatric patients with heart disease. Total scores range from 0 to 100, where higher scores indicate a better outcome (better disease-specific quality of life).

Assesses the level of psychological resilience in children and adolescents. Total scores range from 37 to 185 (based on 37 items), where higher scores indicate a better outcome (greater psychological resilience).

Evaluates behavioral and emotional problems in children and adolescents, as reported by parents or guardians. Results are reported as T-scores typically ranging from 28 to 100, where higher scores indicate a worse outcome (more severe behavioral or emotional problems).

A self-report assessment to evaluate the presence and severity of depressive symptoms in children and adolescents. Scores range from 0 to 56, where higher scores indicate a worse outcome (more severe depressive symptoms).

A self-report instrument designed to assess the level and nature of anxiety in children and adolescents. Results are reported as scores typically ranging from 0 to 40, where higher scores indicate a worse outcome (greater severity of anxiety).

Proportion and rate of adverse events and serious adverse events occurring during exercise.

The volume of oxygen consumed per minute during the cardiopulmonary exercise test. Unit: L/min.

The volume of carbon dioxide produced per minute during the cardiopulmonary exercise test. Unit: L/min.

The ratio of carbon dioxide production to oxygen consumption during the cardiopulmonary exercise test. Unit: Ratio

The total volume of air inhaled and exhaled per minute during the cardiopulmonary exercise test. Unit: L/min.

The ratio of minute ventilation to oxygen consumption, reflecting ventilatory efficiency. Unit: Ratio

The ratio of minute ventilation to carbon dioxide production, reflecting ventilatory efficiency. Unit: Ratio

The amount of oxygen consumed per heart beat during the cardiopulmonary exercise test. Unit: mL/beat.

The blood oxygen saturation level measured via pulse oximetry during the cardiopulmonary exercise test. Unit: %.

The highest heart rate achieved during the cardiopulmonary exercise test. Unit: beats per minute (bpm).

The total weight of skeletal muscle in the body measured by bioelectrical impedance analysis. Unit: kg.

The total weight of fat in the body measured by bioelectrical impedance analysis. Unit: kg.

The percentage of total body weight that consists of fat, measured by bioelectrical impedance analysis. Unit: %.

The ratio of abdominal fat, evaluated by waist-to-hip circumference ratio via bioelectrical impedance analysis. Unit: %.

The ratio of extracellular water to total body water, measured by bioelectrical impedance analysis. Unit: %.

A measure of arterial stiffness derived from the radial artery pulse wave, standardized to a heart rate of 75 bpm (AIx@75). Unit: %.

The speed of the arterial pulse propagating from the carotid to the femoral artery, reflecting arterial stiffness. Unit: m/s.

The percentage increase in brachial artery diameter following a period of ischemia, assessing endothelial function. Unit: %.

The total distance a participant can walk on a flat, hard surface in exactly 6 minutes. Unit: meters (m).

The maximum isometric knee extension peak torque measured by an isokinetic dynamometer. Unit: Newton meters (N.m).

The total number of chair stand squats completed within exactly one minute. Unit: repetitions.

The maximum isometric handgrip strength measured using a hand dynamometer. Unit: kg.

The maximum distance reached forward while sitting with legs extended, assessing lower back and hamstring flexibility. Unit: cm.

The maximum pressure generated during inspiration against an occluded airway, assessing respiratory muscle strength. Unit: mmH2O.