Effects of a pulmonary rehabilitation program on physical capacity, peripheral muscle function and inflammatory markers in asthmatic children and adolescents: study protocol for a randomized controlled trial.

Background: Individuals with chronic lung disease are more susceptible to present reduction in exercise tolerance and muscles strength not only due to pulmonary limitations but also due systemic repercussions of the pulmonary disease. The aim of this study is to assess the physical capacity, peripheral muscle function, physical activity in daily life, and the inflammatory markers in children and adolescents with asthma after pulmonary rehabilitation program.

Method: This is a study protocol of randomized controlled trial in asthmatic patients between 6 to 18 years old. The assessments will be conducted in three different days and will be performed at the beginning and at the end of the protocol. First visit: quality of life questionnaire, asthma control questionnaire, pre- and post-bronchodilator spirometry (400 μcg salbutamol), inflammatory assessment (blood collection), and cardiopulmonary exercise test on a cycle ergometer to determine aerobic capacity. Second visit: assessment of strength and endurance of the quadriceps femoris and biceps brachii muscles with concomitant electromyography to assess peripheral muscle strength. Third visit: incremental shuttle walk test (ISWT) and accelerometer to evaluate functional capacity and physical activity in daily life during 7 days. Then, the volunteers will be randomized to receive pulmonary rehabilitation program (intervention group) or chest physiotherapy + stretching exercises (control group). Both groups will have a supervised session, twice a week, each session will have 60 minutes duration, with minimum interval of 24 hours, for a period of 8 weeks. Intervention group: aerobic training (35 minutes) intensity between 60 to 80 % of the maximum workload of cardiopulmonary exercise testing or of ISWT; strength muscle training will be applied to the quadriceps femoris, biceps brachii and deltoid muscles (intensity: 40 to 70 % of maximal repetition, 3 x 8 repetition); finally the oral high-frequency oscillation device (Flutter®) will be used for 5 minutes. The control group: oral high-frequency oscillation device (Flutter®) for 10 minutes followed by the stretching of upper and lower limbs for 40 minutes. It is expected to observe the improvement in aerobic capacity, physical activity in daily life, muscle strength and quality of life of patients in the intervention group, and reduction in inflammatory markers.

Clinical Trial Number: NCT02383069. Data of registration: 03/03/2015.