Comparison between breathing and aerobic exercise on clinical control in patients with moderate-to-severe asthma: protocol of a randomized trial

Karen B Evaristo, Milene G Saccomani, Milton A Martins, Alberto Cukier, Rafael Stelmach, Marcos R Rodrigues, Danilo F Santaella, Celso R F Carvalho, Karen B Evaristo, Milene G Saccomani, Milton A Martins, Alberto Cukier, Rafael Stelmach, Marcos R Rodrigues, Danilo F Santaella, Celso R F Carvalho

Abstract

Background: Asthma is a chronic inflammatory airway disease characterized by reversible obstruction, inflammation and hyperresponsiveness to different stimulus. Aerobic and breathing exercises have been demonstrated to benefit asthmatic patients; however, there is no evidence comparing the effectiveness of these treatments.

Methods/design: This is a prospective, comparative, blinded, and randomized clinical trial with 2 groups that will receive distinct interventions. Forty-eight asthmatic adults with optimized medical treatment will be randomly divided into either aerobic (AG) or breathing exercises (BG). Patients will perform breathing or aerobic exercise twice a week for 3 months, totalizing 24 sessions of 40 minutes each. Before intervention, both groups will complete an educational program consisting of 2 educational classes. Before and after interventions, the following parameters will be quantified: clinical control (main outcome), health related quality of life, levels of anxiety and depression, daily living physical activity and maximal exercise capacity (secondary outcome). Hyperventilation syndrome symptoms, autonomic nervous imbalance, thoracoabdominal kinematics, inflammatory cells in the sputum, fraction of exhaled nitric oxide (FENO) and systemic inflammatory cytokines will also be evaluated as possible mechanisms to explain the benefits of both interventions.

Discussion: Although the benefits of breathing and aerobic exercises have been extensively studied, the comparison between both has never been investigated. Furthermore, the findings of our results will allow us to understand its application and suitability to patients that will have more benefits for every intervention optimizing its effect.

Trial registration: Clinicaltrials.gov; Identifier: NCT02065258.

Figures

Figure 1
Figure 1
Study flow chart: after inclusion, patients will be evaluated twice. In visit one clinical control, pulmonary and systemic inflammation and psychosocial variables will be measured and in visit two pulmonary function, maximal exercise capacity, thoracoabdominal kinematics and autonomic control will be assessed; afterwards subjects will begin the educational program, consisting of two classes: one related to the disease and skills concerning medication and self-monitoring, and other related to control of external factors and peak flow meter usage. Only then, subjects will be randomized into aerobic or breathing group for 24 sessions, after which they will be revaluated.

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