DUGi

The implementation of a cardiac rehabilitation program adapted to child’s requirements in paediatric population with congenital heart disease: a randomized, controlled, and open-label clinical trial

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BACKGROUND. Congenital heart diseases are the most frequent malformation that occur during birth. Due to the extraordinary advances in diagnosis and treatment, nowadays, a huge number of children reach adulthood, however, evidence demonstrates that these children are involved in some functional and cognitive limitations, outlining lower physical condition and quality of life. Implementing a cardiac rehabilitation program for those patients has shown an improvement of quality of life and cardiopulmonary endurance, even though, an insignificant percentage of children around the world take part in what of them. This may be explained by a lack of adaptation to the interest of the child, thus decreasing his motivation. OBJECTIVE. This clinical trial aims to assess whether a game-based outdoor cardiac rehabilitation program based on Nordic walking and plyometrics improves the health-related quality of life in congenital heart disease paediatrics population, in comparison to those who participate in a conventional cardiac rehabilitation program. DESIGN. A prospective, randomized, controlled and open-label intervention clinical trial, carried out in Cardiac Rehabilitation Unit in Parc Hospitalari Martí i Julià. PARTICIPANTS. Participants included in this study are children from 8 to 12 years old with a diagnosis of congenital heart disease in the Region of Girona. The sample size will be 106 patients, with 53 in each group. METHODS. 106 patients will be recruited in a random simple sampling from the Hospital database, and contacted with their legal guardians by phone. Patients will be randomized into two groups, an experimental group that will be undergoing a game-based outdoor cardiac rehabilitation program based on Nordic walking and plyometrics; and a control group that will take part in a conventional cardiac rehabilitation program. Apart from the training exercise, both programs will be equally. Patients will be assessed for measure endpoints of the study before starting the program, in 6-week, finishing the program (12-week), in 6- month and 12-month follow-ups. Results will be analysed and compared in both groups