Abstract
BACKGROUND: Aerobic training (AT) and behavioral intervention (BI) aimed at increasing physical activity provide numerous benefits to patients with asthma. However, the comparison between the two interventions in the clinical control of this disease is poorly understood. OBJECTIVE: This study aims to compare the effects of AT and BI on disease control in people with moderate to severe asthma. METHODS: This is a randomized 2-arm clinical trial with a blinded evaluation. The study will include 56 physically inactive adults with uncontrolled asthma despite optimized medication. Eligible patients will be randomized into either the AT group or the BI group. AT will be performed on a treadmill for 8 weeks (2 sessions per week, 45 minutes each), and the intensity will be determined by the maximum heart rate established in the cardiopulmonary exercise test. BI will be based on social cognitive theory and behavioral change stages that will last 8 weeks (1 session per week, 90 minutes per session). All interventions will last a total of 12 hours. Assessments will be conducted pre- and postintervention and again 16 weeks later and will include physical activity in daily life (PADL; assessed using triaxial accelerometry) level, body composition (measured using octopolar bioimpedance), barriers to PADL (questionnaire), clinical asthma control (Asthma Control Questionnaire), quality of life (Asthma Quality of Life Questionnaire), anxiety and depression levels (Hospital Anxiety and Depression Scale), and number of exacerbations. Time and group interactions will be evaluated using 2-way repeated measures ANOVA. The significance level will be set at P<.05. RESULTS: As of October 2025, 52 participants had been recruited. This study was funded by the São Paulo Research Foundation and the National Council for Scientific and Technological Development. Clinical trial registration was granted in May 2022. Recruitment and data collection for the trial are ongoing, and the results of this study are expected to be available by the end of December 2026. CONCLUSIONS: This is the first study to compare the effects of AT versus BI on increasing physical activity for clinical asthma control. Therefore, the results obtained in the proposed protocol may provide essential information for health care professionals when recommending these approaches to people with asthma. TRIAL REGISTRATION: ClinicalTrials.gov NCT05364632; https://clinicaltrials.gov/study/NCT05364632. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/78603.