Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 5, 2025
Date Accepted: Sep 22, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effects of aerobic training versus behavioral intervention to increase physical activity in controlling disease in patients with asthma: a randomized trial protocol
ABSTRACT
Background:
Aerobic training (AT) and behavioral interventions to increase physical activity (BI) provide numerous benefits to patients with asthma. However, the comparison of both interventions in the clinical control of this disease is poorly known.
Objective:
To compare the effects of AT and BI in clinical control in individuals with moderate to severe asthma.
Methods:
This is a randomized two-arm clinical trial with blind evaluation. The study will include 56 physically inactive adult patients with non-controlled asthma despite optimized medication. Eligible patients will be randomized into aerobic training (ATG) or behavioral intervention (BIG) groups. The AT will be performed on a treadmill for eight weeks (2xweek; 45 min for each session), and the intensity will be determined by the maximum heart rate established in the cardiopulmonary exercise test (CPET). The BI will be based on social cognitive theory and behavior change stages that will last eight weeks (1xweek, 90 min per session). All interventions will last a total of 12 hours. Pre- and post-intervention and 16 weeks later assessments will include physical activity daily life level (PADL, triaxial accelerometry), body composition (octopolar bioimpedance), barriers to PADL (questionnaire), clinical asthma control (asthma control questionnaire, ACQ), quality of life (asthma quality of life questionnaire, AQLQ), anxiety and depression levels (hospital anxiety and depression scale, HADS), and number of exacerbations. Time and group interactions will be evaluated using analysis of variance with repeated two-way measurements. The significance will be adjusted to 5% P values < 0.05.
Results:
The results will be clinically relevant because they will provide relevant information to clinicians.
Conclusions:
Despite the results, it will be possible to identify if one of these interventions better improve clinical control. Clinical Trial: NCT05364632
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