LIving BEtteR with asThma studY (LIBERTY): a protocol for a pilot study investigating the effects of a structured responsive exercise training programme with psychological and behavioural support for patients with difficult asthma

<ns3:p>Background Difficult-to-treat (difficult) asthma remains a significant public health challenge, with poor control leading to increased exacerbations, reduced quality of life (QoL), and greater healthcare use. Physical inactivity, obesity, breathing pattern disorders, and psychological distress contribute to symptom burden and exacerbation risk. Exercise training, breathing retraining, dietary intervention, behavioural change and emotional self-management have shown benefits in improving asthma control, fitness, and QoL. However, engagement remains a challenge. This study will evaluate whether a structured, community-based multimodal intervention integrating supervised exercise, breathing retraining, and behaviour change support can improve asthma control and patient outcomes in individuals with difficult asthma. Methods LIBERTY is a single-centre pilot study evaluating the delivery and preliminary impact of a structured, community-based multimodal intervention in patients with difficult asthma. Participants will undertake a 24-week programme incorporating supervised exercise, breathing retraining, dietary intervention, behavioural change and emotional self-management. Participants will be recruited from severe asthma clinics and research databases. The pilot study will assess key process outcomes, including recruitment and retention rates, adherence, safety, and acceptability of the intervention. The primary clinical outcome is change in the Asthma Control Questionnaire (ACQ-6) and will be assessed to inform the design and sample size calculations for a future definitive trial. Secondary outcomes include quality of life, exercise capacity, symptom burden, and emotional wellbeing. Exploratory outcomes include mechanistic biomarker analysis. Participants will be followed up for six months after the intervention, to a total study duration of 12 months. Conclusions The LIBERTY pilot trial will assess whether a structured, multimodal intervention incorporating exercise, breathing retraining, behavioural change, and emotional self-management support, is feasible and accpetable to patients, and can improve clinical and patient-reported outcomes in patients with severe asthma.</ns3:p>